Job Openings | 3 Key Consulting

Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15110) - Thousand Oaks, CA

Wed, 11 Mar 2026 14:36:31 GMT

Job Title: Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15110)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Physical Methods Development, Modelling and Emerging Methods
Duration: 12+ months with likely extensions and/or conversion to permanent
Rate: $36-41/Hr. - W2 with benefits
Posting Date: 02/18/2026
Notes: Will be onsite at least 2x/ week

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: 2 Years of Experience, hands on engineering, validation and qualifying equipment.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.

Skills:

Previous intern experience is a plus
Experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.

Top Must Have Skills:

Method Development and Validation
New equipment validation IQ OQ PQ
Supported lifecycle documentation
Gauge Repeatability and Reproducibility studies.

Day to Day Responsibilities:
Executed equipment and method validation activities, including development and execution of
IQ/OQ protocols, equipment characterization studies, and performance qualification support in a regulated manufacturing environment.

Red Flags:
No Medical Device experience

Basic Qualification
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Interview process:
2 Rounds for virtual interviews.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Drug Product Manufacturing Data Analysis – REMOTE (JP15113) - Thousand Oaks, CA

Wed, 11 Mar 2026 12:03:18 GMT

Job Title: Associate Engineer, Drug Product Manufacturing Data Analysis – REMOTE (JP15113)
Location: Thousand Oaks, CA. 91320 OR Cambridge, MA. 02181 (REMOTE)
Employment Type: Contract
Business Unit: Commercial DP - Digital Tech and Data Sciences
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/11/26
Pay Rate: $32 - $35/hour W2
Notes: Only qualified candidates need apply. This position is remote but preferably someone who is located near Thousand Oaks or Cambridge sites for occasional onsite Dayshift 8AM - 5PM.

3 Key Consulting is hiring an Associate Engineer, Drug Product Manufacturing Data Analysis for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Remote but preferably someone who is located near Thousand Oaks or Cambridge sites for occasional onsite
Dayshift 8AM - 5PM.

Our ideal candidate will have some industry experience through internship or research projects with bachelors degree, Educational background in engineering, data sciences, biology, chemistry, or related discipline. Drug product experience in Fill finish or inspection. Experience with Excel, statistical process control, Spotfire or Tableau

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:
Ideal candidate: some industry experience through internship or research projects with bachelors degree, Educational background in engineering, data sciences, biology, chemistry, or related discipline. Drug product experience in Fill finish or inspection. Experience with Excel, statistical process control, Spotfire or Tableau

Educational background in engineering, biology, chemistry, or related discipline
Manufacturing experience; strongly preferable for this experience to be in drug product/ pharmaceutical field Manufacturing experience in other fields also may be considered, depending on relevance of skills involved and transferability/applicability to this position
Experience with data entry, verification, analysis, and/or data management IS systems

Day to Day Responsibilities:

Implementation/enhancement of digital systems and automated analysis/visualization tools (Spotfire) that are utilized for streamlining data management and data monitoring
Data extraction, verification, analysis, and technical reports for process monitoring
Supporting investigations of adverse signals identified through process data monitoring
Integration of new products and processes to data monitoring business process and quality management system
Support for other ad hoc studies and projects as applicable (e.g. technology transfers of processes to new sites

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Red Flags:

Lack of consistency, focus, or direction (in terms of career trajectory and interests)
Lack of clear interest in or motivation for taking on this specific role

Interview process:
1) Preliminary phone interview
2) Team video interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Automation Engineer, Biotech Facilities & Engineering (JP15096) - Thousand Oaks, CA

Mon, 09 Mar 2026 12:07:09 GMT

Job Title: Automation Engineer, Biotech Facilities & Engineering (JP15096)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities & Engineering
Employment Type: Contract
Duration: 3 years with possible conversion to FTE
Rate: $58 - $68/hour - W2 with benefits or Market Rate for highly qualified candidates.
Posting Date: 3/9/2028.
Note: Fully Onsite - Standard 8am-5pm Working hours.

3 Key Consulting is hiring! We are recruiting a Principal Automation/Control Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal candidate: Must have background in within Life sciences specifically Biotechnology and Biomedical Engineering. Emerson Delta-V DCS Programming Experience, Rockwell Automation SCADA and PLC Experience, Compliance with regulatory requirements such as 21 CFR Part 11, Minimum of Bachelors Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.

The company Manufacturing and Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, is looking for Engineers to support Clinical & Commercial Plant Automation programs and Capital projects, including complex and challenging automation initiatives that require a solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, product lifecycle management, and operational excellence. They will require an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.

Job Description & Responsibilities:

Support automation capital project software development testing, commissioning activities etc.
Support day to day operations of the plant for automation related issues including on call rotation every 7-8 weeks.=
Support Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with cross functional teams.
Support Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
Support Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and Amgen CMDB systems.
Ensure compliance to Amgen Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

Preferred Qualifications:

Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product plant operations.
Has five or more years combined experience with the following automation systems:
- Emerson Delta-V DCS system.
- Rockwell Automation SCADA and PLC Platform.
- ABB Robot and Mitsubishi roller bottle machine
- Emerson Delta-V DCS system.
- Electronic Batch Reporting Systems Design and implementation experience.
- Process Control Network design including network segregation.
- Process Control Systems: Virtual Infrastructure design and implementation.
- System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
- Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.

Top Must Have Skill Sets:
1. Must have direct programming experience in Rockwell and/or Emerson and/or HMI and/or Allen Bradley
2. Life Sciences GMP experience
3. Experience with supporting automation capital projects (qualification, testing)

Basic Qualifications:
Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience

Why is the Position Open?
Supplement additional workload on team

Interview Process:
One Phone screen with Hiring Manager and One Panel Interview with team. Both Virtual.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076) - Thousand Oaks, CA

Thu, 05 Mar 2026 14:41:07 GMT

Job Title: Engineer, Upstream/Downstream Drug Substance Process Development & Tech Transfer – REMOTE (JP15076)
Location: Thousand Oaks, CA. 91320 (100% Remote)
Employment Type: Contract
Business Unit: Drug Substance Technology Engineering
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/5/26
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. Remote - EST preferred - Open to all US remote candidates

3 Key Consulting is hiring an Engineer, Upstream/Downstream Drug Substance Process Development for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate will have 3+ years of experience in tech transfer of Biologics Drug Substance upstream and/or downstream required (Cell Culture, Harvest, Chromatography, filtration, UFDF unit ops), Knowledge of upstream and downstream processes/equipment; scale-up factors, process deviations, quality attributes. GMP or lab experience is a nice to have. Strong problem solving and troubleshooting experience would be a plus.

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Cambridge, MA. site. Providing strong process engineering/ technology transfer support of human therapeutic products in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Engineer will apply process engineering knowledge in support of upstream and/or downstream technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer.

Why is the Position Open?
Supplement to the teams ongoing needs.

Top Must Have Skills:

At least 2 years of Biologics / Drug Substance tech transfer experience required (Cell culture/ harvest/ Chromatography/ filtration/ UFDF unit ops).
At least 2 years of experience in the lab scale development work or in the manufacturing environment (pilot plant or GMP)
Strong analytical capability, troubleshooting, and problem solving skills

Day to Day Responsibilities:
Under guidance of senior staff, the Engineer will perform the following:

Transfer processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities
Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
Assist in troubleshooting clinical and commercial runs
Execute data trending and statistical process analysis
Support technical direction for process-related deviations, CAPAs, and change controls
Identify and support process-related operational excellence opportunities
Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

Basic Qualifications:
Master’s degree
OR
Bachelor’s degree and 2 years of Engineering or Operations experience
Associate’s degree and 7 years of Engineering or Operations experience
OR
High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications:

Master’s Degree in Chemical or Biochemical Engineering
1+ years of Process Engineering experience preferably related to upstream and/or downstream purification of commercial cGMP manufacturing facilities
Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
Biologics process knowledge: Knowledge of processes (cell culture, harvest, chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill) and equipment; scale-up factors, process deviations, quality attributes
Strong analytical capability, troubleshooting, and problem solving
Independently motivated with ability to multi-task and work in teams, especially if remote or hybrid.
Excellent written and verbal communication skills with technical writing and presentation experience

Red Flags:

Too much experience (15+ years)
Many job changes within a year or less

Interview process:
1. Teams screening first
2. Panel interviews second

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Substance Bioprocessing/Process Development & Optimization – REMOTE (JP15073) - Thousand Oaks, California

Wed, 25 Feb 2026 11:38:35 GMT

Job Title: Engineer, Drug Substance Bioprocessing/Process Development & Optimization – REMOTE (JP15073)
Location: Thousand Oaks, CA. 91320 (100% REMOTE)
Employment Type: Contract
Business Unit: Drug Substance Technologies Business Operations
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 02/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. Fully remote.

3 Key Consulting is hiring an Engineer, Drug Substance Bioprocessing/Process Development & Optimization for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

IDEAL QUALIFICATIONS:

Drug Substance Bioprocessing background required.
2+ years Prior experience in process development/ /Process Engineering environment, clinical or commercial scale manufacturing, or tech transfer, with specific experience in the implementation, scale up, and support of biopharmaceutical manufacturing processes.
Experience leading or supporting process optimization/ continuous improvement projects
Some understanding of regulatory and cGMP requirements.
Experience with project management. Has the ability to manage projects independently, break down high level projects into smaller incremental tasks, and elevate relevant issues to project lead and line management.
Some experience with digital tools and/or data visualization software (e.g. Tableau, Spotfire, Smartsheet, Sharepoint, AI tools).
Excellent written and verbal communication.
Able to adapt to changing business needs and operational requirements.
Experience with issue resolution and ability to influence across support organizations.
Bachelor’s degree (Chemical Engineering, Bioengineering or Biotechnology, computer science, or other quantitative discipline)

IDEAL BEHAVIORS:

Enjoys tackling challenges, working in teams, and excels at organizing information from numerous sources to provide well-constructed deliverables.
High attention to detail and quality in work.
Ability to collaborate well cross-functionally between departments and work closely with team members to accomplish larger tasks.
Passion for proactively identifying opportunities and solutions through creative data analysis.
Intellectual curiosity with ability to learn new concepts/frameworks and technology rapidly as needs arise.
Ability to problem solve, conceptualize solutions independently, escalate issues appropriately, and integrate feedback.
Ability to ask clarifying questions and seek guidance when necessary.
Ability to manage multiple projects simultaneously and deliver results in a timely fashion.
Accountable, Self starter, and quick learner

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Drug Substance Bioprocessing/Pharmaceutical background. Preference for candidates with previous experience in tech transfer, process development, clinical or commercial scale manufacturing,
Experience leading or supporting business process optimization/ continuous improvement projects
Soft Skills – Communication, self starter/ independent, quick learner, project management

Day to Day Responsibilities:

Optimization of business processes related to Drug Substance pharmaceutical manufacturing, such as technology transfer.
Generate business process documentation such as Guidelines, job aids, templates, and Standard Operating Procedures (SOPs), with feedback from SMEs and management.
Collaborate with partner organizations to develop and deploy digital business process solutions to facilitate knowledge management and business process execution.
Support strategy development to identify tech transfer business process pain points and deploy solutions to improve processes.
Collaborating with multiple stakeholders to understand project timelines, create a project plan, and execute the project deliverables in a timely fashion.
Develop visualization dashboards to communicate OKRs, metrics, and process improvements. Deliver presentations to management and cross-functional partners.

No Drug substance tech transfer/ engineering experience
No experience with continuous improvement
No experience with cross functional teams
No independent leadership. Roles are purely task based

Interview process:
Phone and WebEx interviews. Up to 3 interviews (Manager & 2 x panel of 3 or 4 team members)

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Validation Engineer (CSV), Biotechnology - (JP15063) - Holly Springs, NC

Mon, 23 Feb 2026 12:31:23 GMT

Job Title: Senior Validation Engineer (CSV), Biotechnology - (JP15063)
Location: Holly Springs, NC. 27540
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 9+ months (with likely extensions and/or conversion to permanent)
Posting Date: 02/23/26
Pay Rate: $60 - $70/hour W2 with benefits
Notes: Only qualified candidates need apply. Fully Onsite. Standard Working Hours 8:00AM - 5:00PM

3 Key Consulting is hiring a Senior Validation Engineer (CSV), Biotechnology for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues. Additional responsibilities will include support in development of audit readiness materials and gmp documentation generation and review. This is an on site position.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:
Inspection
Shut down
Validation

Day to Day Responsibilities:
General validation and commissioning support, generation and management of documents, support of audit readiness, other engineering support tasks.

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Preferred Qualifications:

Employee Value Proposition:

Red Flags:
No pharmaceutical experience
Job Hopping without valid explanation

Interview process:
One video interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Rockwell / Allen Bradley PLC troubleshooting - (JP15048) - New Albany, OH

Mon, 23 Feb 2026 10:32:22 GMT

Job Title: Associate Engineer, Rockwell / Allen Bradley PLC troubleshooting - (JP15048)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Systems Engineering
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 02/23/26
Pay Rate: $28 - $32/hour W2 with benefits
Notes: Only qualified candidates need apply. Fully onsite New Albany, OH. Shift details: PM shift 6:00 pm – 6:30 am, 2-2-3 schedule.

3 Key Consulting is hiring an Associate Engineer, Rockwell / Allen Bradley PLC troubleshooting for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Ideal candidate is an Automation Technician (2 years) with strong hands-on PLC troubleshooting skills, ladder logic reading, HMI familiarity, and packaging equipment experience. Able to collaborate with mechanical techs, and adept at diagnosing electrical/automation issues in a GMP manufacturing environment. Industry background is flexible; key requirement is practical automation experience. Strong communication and problem-solving skills are essential.

In this role, you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area in Non-Standard Shifts structure.

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Rockwell / Allen Bradley PLC troubleshooting experience. Must be able to login and use the PLC program to do basic troubleshooting.
Troubleshooting production equipment. Must be able to use a multimeter and read electrical schematics.
Strong communication skills are essential.

Day to Day Responsibilities:

Support production by quickly troubleshooting and resolving issues on packaging equipment.
Most equipment is controlled by Rockwell / Allen-Bradley controls. Others include Siemens and B&R controls.
Sub-systems on equipment include Systech serialization, Cognex cameras, SCADA.
Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Support cGMP validation of equipment and processes.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and client policies.
Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for equipment/systems.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program troubleshoot and repair equipment/system failures.
Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
Support Operations using Current Good Manufacturing Practices (cGMP).
Support Operations in non-standard shifts that include weekends and/or holidays as determined by the business.

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Red Flags:

No demonstrated PLC experience.
Poor communication.

Interview process:

2 interviews, both via Microsoft Teams.

The first will be a brief one-on-one interview with hiring manager. 15-25 minutes.
The second will be a panel interview with two or three people. 30 - 45 minutes

Engineer, Complaints Technical Investigator, Medical Devices (JP15046) - Thousand Oaks, CA

Thu, 19 Feb 2026 11:10:41 GMT

Job Title: Engineer, Complaints Technical Investigator, Medical Devices (JP15046)
Location: Thousand Oaks, CA. 91320
Business Unit: Complaints Investigations
Employment Type: Contract
Duration: 12 months (with likely extensions and/or conversion to permanent!)
Rate: $36 - $42/hour W2 with Benefits
Posting Date: 2/19/2026
Notes: NO RELOCATION CANDIDATES - Local role, hybrid onsite to ATO is required 3 times per week.

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company. automotive manufacturing and services company.

The ideal candidate for this role will have at least 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices. They should be proficient with ISO systems, risk analysis processes, and protocol or report writing. A bachelor's degree in engineering or sciences such as chemistry, physics, or biology is strongly preferred, though candidates with other educational backgrounds who possess robust laboratory experience will also be considered. Experience working in biohazard lab settings is a plus, but not mandatory. Excellent written and verbal communication skills, along with strong presentation abilities, are essential as the role involves regular presentations to internal teams.

Candidates must have a background in medical devices, biotech, or biopharma industries and must be local, able to commute onsite 2–3 days per week (ideally residing within Los Angeles, Orange, or Ventura Counties). This role will begin as a one-year contract, with the potential for extension.

Job Description:
Seeking an Engineer - Complaints Technical Investigator supporting Complaints Trending and Investigation group, a diverse team working to continuously improve clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of client’s packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.

JOB RESPONSIBILITIES:

Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends
Provide input to engineering for product improvements
Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms
Lead root cause analysis to identify the failure mode for client’s products and associated components due to product complaint
Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, “5 Whys”, risk assessments such as FMEA’s, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.
Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation
Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

PREFERRED QUALIFICATIONS

Master’s Degree in Science
5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
Understand customer / patient use of client’s packaged and/or distributed products
Understand manufacturing processes for client’s packaged and/or distributed products
Proven experience with medical devices
Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
Experience with protocol and report writing, process and test development and execution, and design of experiments
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Strong technical writing and interpersonal skills

Top Must Have Skill Sets:

Experience with protocol and report writing, process and test development and execution, and design of experiments
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Strong technical writing and interpersonal skills

Why is the Position Open?
Supplement additional workload on team.

Red Flags: Must be local. No relocation.

Interview Process:
Three members of CTI/Complaints/Operations | All Virtual Meetings

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15044) - Thousand Oaks, CA

Wed, 18 Feb 2026 11:46:28 GMT

Job Title: Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15044)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Physical Methods Development, Modelling and Emerging Methods
Duration: 12+ months with likely extensions and/or conversion to permanent
Rate: $36-41/Hr. - W2 with benefits
Posting Date: 02/18/2026
Notes: Will be onsite at least 2x/ week

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: 2 Years of Experience, hands on engineering, validation and qualifying equipment.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.

Skills:

Previous intern experience is a plus
Experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.

Job Details:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for container closure integrity testing (CCIT) related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. Assist with project definition by performing engineering studies and assessment for CCIT system installations. Perform field evaluations of existing systems and provide engineering design recommendations and support development of CCIT technologies.

Basic Qualification
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Top Must Have Skills:

Nice to have skills: (manager would like to see but not all skills are a hard requirement)
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership. 
Statistical analysis, and knowledge of Gage R&R,  
Knowledge of Optical measurement devices, force testers, BLE testing. 
Test method development, CAD design, SolidWorks, mechanical modeling. 
Manufacturing experience, IQ, OQ, and PQ.

Day to Day Responsibilities:

Equipment and Method validation principles, generation of Lifecycle
Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies. 
Troubleshooting of various lab instruments and automation systems, which will require learning the specific software controlling the instruments and integrated systems from vendor manuals, and site documents.

Red Flags:
No hands on Engineering experiences or credited

Interview process:
2 Rounds for interviews.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

Sr. Associate Facilities – Licensed Electrician – (JP15037) - Thousand Oaks, California

Tue, 17 Feb 2026 11:14:55 GMT

Job Title: Sr. Associate Facilities – Licensed Electrician – (JP15037)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Drug Product Maintenance & Utilities
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 02/17/26
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring a Sr. Associate Facilities – Licensed Electrician for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate will be a licensed Electrician with the must have skills sets listed below.

The Sr. Associate Facilities for a Final Drug Product Operation Facility will be part of the Facilities & Engineering team responsible for providing maintenance leadership and technical expertise in support of safe and reliable facility infrastructure, facility equipment/systems, electrical systems, instrument standards, utility systems, and/or production suites and ensures:

Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.
Supports the efficient operation of site facility infrastructure systems (to include all utility systems, electrical systems, etc.).
Monitors all system status and analyzes to identify trends.
Develops maintenance strategies and programs (preventative, corrective, predictive etc.) to ensure cost effective and reliable operation of all plant equipment and systems.
Facilitates business units' capability to perform their functions.
Working in a regulated cGxP environment, identifies engineering needs for site facilities.
Defines projects, develops innovative solutions, determines engineered solutions, develops project documentation, obtains capital or expense resources.
Represent site as Facilities SME.
Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures (SOPs).
Lead technical root cause analysis, incident investigations and troubleshooting issues related to facility equipment/systems.
Solving complex problems, project management, equipment lifecycle management and operational excellence.
Drawing management for Facilities and Supporting areas.
Determining facility and equipment specifications.

Top Must Have Skills:

Experience in an FDA (GMP) or comparable regulated environment preferably Pharmaceutical and/or Biotechnology industry
Strong knowledge in facilities operations with emphasis on electrical and utilities supporting pharmaceutical facility.
Experience with installation, troubleshooting, maintenance, repair and testing of electrical facility and utilities equipment.

Day to Day Responsibilities:
See Above.

Basic Qualifications:

Bachelor’s degree in Engineering (Mechanical, Electrical or Chemical) + 2 years Engineering and/or Facilities Maintenance work experience.
High school/GED + 8 years Engineering and/or Facilities Maintenance work experience OR
Associate’s + 4 years Engineering and/or Facilities Maintenance work experience.

Red Flags:
Need electrical background. Licensed electrician experience preferred.

Interview process:
Webex or MS Teams Interviews

1 initial screening
Panel Interviews

Engineer, Drug Product Process Development and Tech Transfer Project Support - (JP15004) - Thousand Oaks, California

Tue, 10 Feb 2026 14:15:28 GMT

Job Title: Engineer, Drug Product Process Development and Tech Transfer Project Support - (JP15004)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Drug Product Process Development
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 02/10/26
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. 100% onsite

3 Key Consulting is hiring a Engineer, Drug Product Process Development and Tech Transfer Project Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate for this role should have a bachelor’s degree in any scientific or engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. The candidate should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills.

This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop over time.

As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple client products to the aseptic fill finish manufacturing plants within their Thousand Oaks facilities and which includes various production lines.

The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff.

The candidate will be responsible for interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of client products. The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Have the ability to author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents.
Ability to work independently and as part of a team with internal and external partners.
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies.

Day to Day Responsibilities:

Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
Support development and maintenance of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
Development of digital tools and models by leveraging data analytics and programming skills
Support at scale characterization and/or process validation runs as person in plant

B.S. in scientific or engineering discipline with 1‒3 years’ experience or M.S. in scientific or engineering discipline with 0‒2 years’ experience
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude

Red Flags:
Fresh out of college, no corporate or industry experience

Interview process:
Interview with Manager
Interview with Sr. Engineer
Interview with Sr. Director

Engineer, Drug Product Manufacturing Process Development (JP14993) - Thousand Oaks, California

Mon, 02 Feb 2026 12:40:54 GMT

Job Title: Engineer, Drug Product Manufacturing Process Development (JP14993)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 1+ year(s) – (with likely extensions and/or conversion to permanent)
Posting Date: 02/02/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring an Engineer, Drug Product Manufacturing Process Development for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
We are seeking a skilled Process Development Engineer who can work independently to support technical projects. The ideal candidate will have expertise in laboratory testing, drug product fill finish processing, holistic drug product process knowledge, technical transfer, and drug product manufacturing. Excellent communication skills and proficiency in technical writing are essential for this role.

The Process Development Engineer will:

Author, data verify, and review guideline documents, technical protocols, reports, product impact assessments.
Execute laboratory analytical testing such as: viscosity, protein concentration, pH, osmolality.
Execute laboratory experiments such as pipetting, formulation, filtration.
Provide technical support for drug product process development, including formulation, filtration, and filling (vials/syringes/devices) of parenteral products.
Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.
Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.

Why is the Position Open?
Backfill.

Top Must Have Skills:

Post graduation experience required
Laboratory experience using analytical equipment
Evidence of good communication e.g. writing documents and sharing results
College degree in engineering or similar (chemical engineer, bio engineer, pharmaceutical science, etc)

Day to Day Responsibilities:

On site laboratory work, for example testing viscosity with a rheometer
Maintaining good documentation practices with a laboratory notebook
Analyzing and summarizing results to be communicated out
Documentation and data verification

No recent relevant experience with analytical equipment
Poor communication / organization in resume
Must be based in the US

Interview process:
MS Teams Interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Primary/Secondary Packaging -Regulatory Compliance, Design and Qualification - (JP14964) - Thousand Oaks, California

Fri, 30 Jan 2026 15:57:55 GMT

Job Title: Engineer, Primary/Secondary Packaging -Regulatory Compliance, Design and Qualification - (JP14964)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 01/30/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This position reports into the Clinical and Platform Packaging Engineering group under Combination Products Operations in Thousand Oaks, CA. This position will apply engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and material science is essential to the position.

The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environments.

Why is the Position Open?
Backfill.

Top Must Have Skills:

Regulatory Compliance experience, Design and qualification experience, and Cross-functional collaboration

Day to Day Responsibilities:

Support for testing and evaluation leading to recommendation and selection of primary and secondary packaging materials.
Familiarity with Material Testing standards, requirements and equipment is essential.
Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components.
Writing technical specifications, creating engineering drawings, and developing artwork templates.
Competent with AutoCAD, Illustrator, or similar software application to create, modify and approve engineering drawings.
Support line trials and packaging validation activities prior to introduction of any new or change in components/processes.
Collaborate with cross-functional teams (i.e. Quality, Device Engineering, Supply Chain, Artwork, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
No technical experience. We are not looking for project managers.

Interview process:
MS Teams interview with manager, then likely interview with 2 other senior managers and 1 Sr. Engineer

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Synthetic Kilo Laboratory and Analytical Chemistry Support - (JP14942) - Thousand Oaks, California

Fri, 23 Jan 2026 14:14:32 GMT

Job Title: Engineer Senior, Synthetic Kilo Laboratory and Analytical Chemistry Support - (JP14942)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Mechanical Design Engineering
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 01/24/26
Pay Rate: $46 - $51/hour W2
Notes: Only qualified candidates need apply. Onsite Work Schedule: 8AM - 5PM

3 Key Consulting is hiring an Engineer Senior, Synthetic Kilo Laboratory and Analytical Chemistry Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate holds a bachelor’s degree with four years of relevant industry experience, a master’s degree with two years of experience, or a PhD in Chemical Engineering, Chemistry, or a related discipline, with experience supporting small-molecule API drug substance development.

This role reports to the Associate Director of Engineering and provides on-site laboratory support and scientific contribution. The candidate will work in a highly collaborative, team-based environment alongside process development of chemists, chemical engineers, and analytical scientists. The role also interfaces with Environmental, Health, Safety & Sustainability (EHSS), Facilities & Engineering, laboratory management, and external vendors.

This is a laboratory-focused position requiring strong technical aptitude, curiosity, and motivation to advance synthetic laboratory operations, automation, and data-driven experimentation. The successful candidate will be capable of working independently on defined objectives while contributing effectively within a fast-paced, cross-functional team.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Hands-on execution and support of synthetic chemistry experiments, kilo-lab operations, equipment use, and EHSS-compliant laboratory practices.
Design, execution, and interpretation of HTE workflows for reaction, solubility, and crystallization screening, including use of automation and data-driven experimentation.
Application of analytical and solid-state tools (HPLC, XRPD, DSC/TGA) alongside kinetic modeling and PAT awareness to translate experimental data into process understanding.

Day to Day Responsibilities:
Synthetics Lab Operations and Scientific Support:

Support day-to-day operations of the Synthetics Lab through hands-on experimental execution and technical support.
Operate lab equipment and accessories in compliance with safety and operational procedures; develop increasing proficiency as a lab superuser.
Execute synthetic experiments with minimal supervision and escalate technical or safety concerns as appropriate.
Collaborate with process development of chemists and engineers to generate, interpret, and document experimental data.
Contribute to cross-functional project teams by delivering experimental results aligned with project timelines and objectives.
Author and support review of technical documentation, including process descriptions, batch records, SOPs, and safety documentation.
Review various documentation and mine data using statistical tools.

High-Throughput Experimentation, Automation, and Solid-State Support

Design and execute high-throughput experimentation (HTE) studies for reaction screening and solubility/crystallization screening under project guidance.
Support development and operation of automated HTE workflows to enable efficient and reproducible experimentation.
Execute solubility and crystallization of screening experiments and assist in interpretation of results to inform process development decisions.
Perform solid-state and analytical characterization using techniques such as HPLC, XRPD, DSC/TGA, and related methods.
Document, analyze, and communicate HTE and solid-state data to project teams.
Support the use of kinetic modeling platforms and PAT tools for process understanding and optimization.

Equipment, Lab Operations, and Inventory Support:

Assist with equipment scheduling and coordination to support experimental demands.
Support routine equipment maintenance, troubleshooting, and preventative maintenance activities.
Operate and support maintenance of lab equipment and utilities, including reactors, filtration systems, heat transfer units, and chillers.
Assist with laboratory inventory management, including monitoring usage, ordering consumables, and restocking supplies.
Follow established procedures for equipment handling, maintenance, and repair, escalating complex issues as needed.

Lab Improvements, Training, and EHSS:

Participate in laboratory improvement initiatives, including equipment upgrades, workflow optimization, and automation efforts.
Support development and maintenance of training materials for lab operations and equipment.
Complete required training and support training compliance through the client training system.
Participate in core team meetings and contribute experimental data and technical updates.
Support EHSS risk assessments, safety reviews, and implementation of mitigation actions under guidance from senior staff.

Basic Qualifications:

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
The candidate should demonstrate a solid foundation in chemical synthesis, synthetic laboratory operations, and scale-relevant safety practices.
Strong written, verbal, and presentation skills are required.
Experience with high-throughput experimentation (HTE) for reaction screening, solubility assessment, and crystallization screening is desirable.
Familiarity with automated HTE workflows and solid-state characterization techniques is a plus. Hands-on experience with analytical tools such as HPLC, XRPD, and thermal analysis (DSC/TGA) is advantageous.
Exposure to kinetic modeling platforms and process analytical technology (PAT) tools is preferred.
Proficiency with standard office software (Microsoft Word, Excel, PowerPoint, and Outlook) is required.
Experience with Dynochem or similar process modeling and simulation tools is a plus.

Red Flags:

This is not a remote position; the candidate must be physically present and actively working in the laboratory environment.

Interview process:
Two rounds of interview minimum. Phone screening and zoom/onsite interview. Available immediately to interview as soon as candidates are available to screen.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Drug Manufacturing and Clinical Supply (JP14936) - Thousand Oaks, CA

Fri, 23 Jan 2026 00:02:29 GMT

Job Title: Associate Engineer, Drug Manufacturing and Clinical Supply (JP14936)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Drug Product Supply
Duration: 6 months with likely extensions and/or conversion to permanent
Posting Date: 01/22/2025
Pay Rate: $30 - $35/hour W2 with benefits

3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
In this role you will be joining the Drug Product Pilot Plant team within the Manufacturing and Clinical Supply (MCS) organization Process Development. The team’s mission is to leverage industry-leading pilot plant capabilities for robust, efficient filling process characterization; support company’s drug product manufacturing network, including driving and supporting continuous improvement initiatives related to the filling unit operation; and produce Not for Human Use (NHU) material, freeing up capacity within the GMP plants.

Responsibilities include, but are not limited to, the following:

Set up and operate fill/stoppering equipment for drug product dispensing
Perform format changeovers and material preparation
Lead material generation runs for vial and syringe formats
Execute fill process characterization studies following protocols
Prepare lab notebooks, reports, and documentation
Manage pilot plant raw materials
Draft standard operating procedures (SOPs)
Apply scientific and engineering principles to improve processes
Present study results to management and product teams
Support safety and compliance initiatives

Why is the Position Open?
Planned Project

Top Must Have Skills:

Biopharma Manufacturing (fill-finish) Filling vials and syringes
Equipment Engineering
Problem Solving
Strong Communication

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience.

Employee Value Proposition:
Dynamic team

Interview process:
Phone interviews with Drug Processing Pilot Plant Team

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Biologics Drug Substance PPQ support (JP14922) - Holly Springs, NC

Thu, 22 Jan 2026 13:05:41 GMT

Job Title: Engineer – Biologics Drug Substance PPQ support (JP14922)
Location: Holly Springs, NC. 27540
Employment Type: Contract
Business Unit: ANC PD Site Lead
Duration: 1+ year with likely extensions and/or conversion to permanent
Posting Date: 1/22/2026
Pay Rate: $34 - $38/hour W2
Notes: Hybrid onsite 3-5 days onsite. Standard hours

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: B.S and 1-3 YOE, M.S. with some experience is ideal. Nice to have: Chemical engineering or bioprocessing experience. Process validation or development experience. Technical platforms: Spotfire, Excel, Smartsheet.

Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for process validation scope. Employ basic engineering/validation skills and practices to gather process validation acceptance criteria, process parameter data, and performance indicator data to support PPQ campaigns.

Assist with process validation documentation by documentation reviews and data verification of protocols and reports. Perform process validation floor support as needed for sample management verification. Assist in developing sample packages to support MFG, validation datasheets, raw material inventory for studies, and supporting supply chain needs for validation activities

Skills: Worked in a process validation team or process development team for drug substance biologics.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:
Experience with excel, data verifying, and documentation experience.

Day to Day Responsibilities:

Support process validation team in the initiation, design, and delivery of projects, particularly for process validation scope.
Assist with gathering process validation data, data verifying protocols/reports, and double-checking sample collection

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
Non-scientific background.
Frequent job changes

Interview process:
Initial 1on1 with manager, 2nd round panel style interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Technical Complaints Investigator Drug Delivery Devices - (JP14915) - Thousand Oaks, CALIFORNIA

Thu, 15 Jan 2026 11:56:34 GMT

Job Title: Engineer, Technical Complaints Investigator Drug Delivery Devices - (JP14915)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Duration: 6+ months (with possible extension)
Posting Date: 01/15/26
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. Local candidate must be onsite as needed (approximately 80%.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Sr. Engineer in Complaints Trending and Investigation group. The Complaints Trending and Investigation group here is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis as well as supporting/leading root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Why is the Position Open?
Coverage for partners leave of absence

Top Must Have Skills:

Master’s or Bachelor’s in Engineering, Electrical, Mechanical or Science.
Experience in lab environment
Strong technical writing and interpersonal skills

Day to Day Responsibilities:

Perform device assessments of complaints and document results in a report.
Complete evaluation and deliver assessment report on time per client’s requirements.
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
Support characterization testing and data gathering for investigations

Basic Qualifications:

Master’s degree; OR
Bachelor’s degree and 2 years of related exp in engineering - Electrical, Mechanical, medical/biopharma development or Operations experience; OR
Associate degree and 6 years of related medical/biopharma development or Operations experience.

Preferred Qualifications:

Master’s or Bachelor’s in Engineering, Science or Biomedical
2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience in lab environment
Demonstrated competency in root cause analysis methodology
Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented

Employee Value Proposition:

Red Flags:

“Lab exposure” without specific tools or methods
No mention of testing equipment or analytical methods used
Vague statements like “supported investigations” with no technical detail
Purely desk‑based jobs without any lab environment mentioned
Degrees unrelated to technical or scientific fields
Courses/skills suggesting low technical aptitude
Generalist resumes with very high-level descriptions
-No measurable achievements or quantified results

Interview process:
We will begin by reviewing candidate resumes, conduct phone screens to identify the top three candidates, and then schedule online video interviews. From those interviews, we will select the final candidate to extend an offer

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Biotech Primary/Secondary Packaging Materials & Components - (JP14839) - Thousand Oaks, California

Thu, 08 Jan 2026 12:40:48 GMT

Job Title: Engineer, Biotech Primary/Secondary Packaging Materials & Components - (JP14839)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 01/07/2026
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring an Engineer, Biotech Primary & Secondary Packaging Design and Qualification for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This position reports into the Packaging Engineering group under Combination Product Operations (CPO) and is located in Thousand Oaks, CA. The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position will apply engineering principles to implement the accurate design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. A knowledge of common materials utilized in healthcare packaging is key to this role.

Material knowledge of structural components are integral in the day-to-day oversight of this role: bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc. The position entails interpersonal, project management, technical problem solving and communication (written and verbal) skills, and the opportunity to work in teams and adapt to a continuously evolving environment.

Why is the Position Open?
Backfill.

Top Must Have Skills:

Packaging Engineering experience.
Packaging education.
GMP experience.

Day to Day Responsibilities:

Lead testing and evaluations to recommend and select primary and secondary packaging materials for both large and small molecule products.
Perform distribution testing per ASTM D4169. Complete testing standards using ASTM, ISO, TAPPI, USP and EP.
Writing of test protocols, perform technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components.
Creating specifications along with implementation through technical change records.
Build, modify, and approve engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications.
Support line trials and packaging validation activities prior to introduction of any new or change in components/processes.
Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.) in pre-commercial and commercial activities.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
No packaging engineering experience.

Interview process:
Video Conference, minimum 2 interviews. Can start interviewing immediately

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Biologics Purification Process Development & Purification (JP14792) - Thousand Oaks, California

Fri, 02 Jan 2026 11:12:48 GMT

Job Title: Engineer – Biologics Purification Process Development & Purification (JP14792)
Location: Thousand Oaks, CA. 91320 Hybrid
Employment Type: Contract
Business Unit: Drug Substance Technology Engineering Group
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 01/01/26
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. Hybrid - 3-4 days onsite weekly. Thousand Oaks, CA

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate will have 2-4 years of relevant experience working in drug substances and animal cells. Strong process knowledge. Experience purifying cells (biologics purifications), drug substance GMP manufacturing.

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Engineer will apply purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.
Consultant will work onsite a minimum of 3 days a week.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Must have biotech background/experience, plus must have purification experience
Drug substance biologics process development, pilot plant or manufacturing technical support
Purification of monoclonal antibodies
Experience in GMP environment (preferably in drug substance)

Day to Day Responsibilities:
The Engineer will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:

Short duration stints in prior jobs
Resume does not accurately reflect true experience
Cultural fit - manager described the team as easy going, growth motivated, organized, and respectful.
Too senior or experienced for the position (not looking for more than 7+ years of experience)

Interview process:
Phone interview
Panel interview with 3-4 individuals in the team with manager and director

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Biotech Facilities Project Analysis and Coordination - (JP14822) - Holly Springs, NC

Wed, 10 Dec 2025 12:46:29 GMT

Job Title: Engineer – Biotech Facilities Project Analysis and Coordination - (JP14822)
Location: Holly Springs , NC. 27540
Employment Type: Contract
Business Unit: CPEC Group
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 12/10/25
Pay Rate: $34 - $38/hour W2
Notes: Only qualified candidates need apply. Open for candidates with experience with project engineering and coordination experience

3 Key Consulting is hiring an Engineer – Biotech Facilities Project Analysis and Coordination for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for facilities related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for facilities system, perform quality and overall facilities walkdowns. Perform field evaluations of existing systems and provide engineering design recommendations.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Ability to work well under pressure
Facilities knowledge and experience
Great communication skills
Proactive
Willingness to learn new experiences

Day to Day Responsibilities:

Support to Facilities Sr Mgr. on various ongoing activities, including new projects
Accountable for walkdowns and punch list resolution
Daily responsibilities will vary based on the need from business, it can be from maintenance operation to punch lists resolution.

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
Self-starter.
Ability to communicate effectively.
Manage tasks to completion.
Experience with facilities management and projects is a must.

Red Flags:

Staff with no engineering or facilities experience
Overqualified experience, 10+ years industry experience

Interview process:
Minimum of two interviews

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Biopharma Drug Substance, Single Use – Remote/Hybrid (JP14818) - Thousand Oaks, CA

Mon, 08 Dec 2025 17:36:45 GMT

Job Title: Associate Engineer, Biopharma Drug Substance, Single Use – Remote/Hybrid (JP14818)
Location: Thousand Oaks, Ca 91320
Employment Type: Contract
Business Unit: ETA Drug Substance
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 12/08/2025
Pay Rate: $35 - $40/hour W2 with benefits
Notes: Hybrid - occasionally onsite (meetings, visiting, collaborate with person onsite)
Shift/Schedule: Monday - Friday, 8am - 5pm
Schedule: 90% remote; on-site only for occasional meetings (likely once a month or less).
1 year with possibility to extend

3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate for this Associate Engineer role is an early-career engineer, typically a new graduate or someone with 0–2 years of industry experience, who holds a bachelor’s degree in Mechanical or Chemical Engineering and demonstrates a strong grasp of core engineering principles. Exposure to single-use systems or biotech engineering is helpful but not required; training will be provided.

The candidate should be detail-oriented, comfortable performing data entry into engineering databases, and eager to support design reviews and day-to-day engineering workload alongside a senior engineer. We are seeking individuals who are motivated, collaborative, and genuinely interested in hands-on learning within a highly supportive team. Overqualification is a concern for this role; candidates with extensive engineering backgrounds (e.g., senior or principal-level profiles) will not be a fit. The position is primarily remote with infrequent site visits, so reliability, communication skills, and self-management are essential.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for single use systems. Support senior staff in obtaining, organizing, and entering data for a single-use systems database that will be utilized by a broad, cross-functional user base at the company, in addition to support the triage of new single-use system designs.

The position requires a lot of independent work, which brings a lot of personal satisfaction and success is not largely dependent on group work. The worker will become the new Subject Matter expert of a new system within the company which will be very valuable to potentially obtain a full-time position. The person will be working with single uses systems and therefore interaction with almost all sites and a variety of groups at the company (manufacturing, process development, supply chain, etc.) giving them an opportunity to learn more about the company and how it works.

Top Must Have Skills:

BS Engineering degree in related field (Chemical/Mechanical Engineering), open to new grads
GMP or Biotech industry experience, preferred.
Single use systems (engineering equipment) knowledge preferred
Self-starter and eagerness to learn

Day to Day Responsibilities:
Ideal candidate: training is provided but the ideal candidate can update data into the system and attention to detail is crucial. Someone who can work independently in a fast-paced environment that can accept feedback.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for single use systems. Support senior staff in obtaining, organizing, and entering data for a single-use systems database that will be utilized by a broad, cross-functional user base at the company, in addition to support the triage of new single-use system designs.

The position requires a lot of independent work, which brings a lot of personal satisfaction and success is not largely dependent on group work. This worker will become the new Subject Matter expert of a new system within the company which will be very valuable to potentially obtain a full-time position. The person will be working with single-use systems and therefore interaction with almost all sites and a variety of groups at the company (manufacturing, process development, supply chain, etc.) giving them an opportunity to learn more about the company and how it works.

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Red Flags:
Overqualification:
Individuals with extensive experience (10–25+ years) in engineering roles (Senior, Principal, Staff levels) are not appropriate for an Associate Engineer role.
If it appears they are applying far below their level with no clear reason, this is a concern.

Interview process:
Video interview with Hiring manager
Video interview with Senior Engineer

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Biotech Facilities & Processing Equipment Project Engineering - (JP14802) - Thousand Oaks, CALIFORNIA

Wed, 03 Dec 2025 15:40:53 GMT

Job Title: Engineer Senior, Biotech Facilities & Processing Equipment Project Engineering - (JP14802)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Facilities & Engineering Drug Product Supply
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 12/03/25
Pay Rate: $45 - $50/hour W2
Notes: Only qualifi0065d candidates need apply. Onsite 8-5. Must have CA DL and US Passport (for business travel)

3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The position works in partnership with the maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities at our client facilities in Thousand Oaks (ATO).

Why is the Position Open?
Supplement workload

Top Must Have Skills:

8-10 YOE
Engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support, Reliability, asset management)
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.)

Day to Day Responsibilities:
The Engineer/Project Manager role will provide direct engineering technical and project support as follows:

Be individually accountable for the deliverables on projects.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Develop and present project charters/strategies to leadership.
Developing accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis and data for benchmarking.
Leads team effectiveness by identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items, following appropriate escalation process.
Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
Assist in development and review of User Requirements Specifications (URS).
Identify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.
Partnering with commissioning lead to develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).
Recommend, evaluate, and manage performance of contract resources.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Act as a liaison between cross-functional teams during project planning, execution, and closeout
Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
Ensure safety during commissioning, validation, maintenance and manufacturing activities
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.

Related Activities:

Participate or lead, when required, multidisciplinary site teams, e.g. lead cross functional team, meeting manager, external vendor liaison, etc.
Support Lean Manufacturing and Operational Excellence process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
Provide ad hoc technical support and guidance for manufacturing and maintenance
Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
Participate in internal audits and assess in conjunction with QA.
Assist in developing and maintaining project metrics

Bachelor's degree in engineering or other science-related field
8 or more years of relevant work experience in operations/manufacturing environment
5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support)
Direct experience working within regulated environments (FDA, OSHA, EPA, etc.)
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
Understanding and awareness of industry/regulatory trends for verification/validation
Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.

Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus

Demonstrated strong communication and technical writing skills
Strengths in facilitation and collaboration / networking
Experience in developing SOPs and delivering training
Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.)

Red Flags:
- Experience must be commensurate of senior title
- Multiple roles less than 6 months in duration.
- Must have CA DL and US Passport (for business travel)

Interview process:
2 phone / 1 in-person

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804) - Thousand Oaks, CA

Fri, 28 Nov 2025 10:53:11 GMT

Job Title: Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Function: Process Development / Engineering / Operations
Duration: 12 months with likely extension or conversion to permanent
Rate: $48-52 on W2 with Benefits
Posting Date: 11/28/2025

3 Key Consulting is hiring a Senior Packaging Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description / Responsibilities:

Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors).
Create and maintain component specifications for vials, stoppers, syringes, seals, cartons, labels, and distribution packaging
Develop and execute packaging test protocols including:
- Transportation simulation (ISTA/ASTM)
- Aging and shelf-life studies
- Cold-chain and environmental conditioning
- Packaging line engineering studies
Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607, USP).
Prepare and review packaging documentation for regulatory submissions.
Support tech transfer, scale-up, and readiness activities at Company’s manufacturing sites and CMOs.
Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.
Partner with suppliers and Procurement to qualify components, assess supplier capability, and manage change notifications.
Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements.

Preferred Qualifications:

Master’s degree in Engineering or related field.
Experience with combination products, injection devices, and cold-chain distribution systems.
Knowledge of paperboard, structural design & FEA

Why is the Position Open?
Supplement additional workload on team

Top Must-Have Skill Sets:

On-Site
Packaging Engineering Experience
Experience with Paper-Based Packaging

Day to Day Responsibilities

Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors).
Create and maintain component specifications for vials, stoppers, syringes, seals, cartons, labels, and distribution packaging.
Develop and execute packaging test protocols including:
- Transportation simulation (ISTA/ASTM)
- Aging and shelf-life studies
- Cold-chain and environmental conditioning
- Packaging line engineering studies
Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607, USP).
Prepare and review packaging documentation for regulatory submissions.
Support tech transfer, scale-up, and readiness activities at company’s manufacturing sites and CMOs.
Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.
Partner with suppliers and Procurement to qualify components, assess supplier capability, and manage change notifications.
Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements.

Employee Value Proposition:
Unique industry opportunity and experience.

Red Flags:

Gaps in employment
Currently resides more than 100 miles away
Multiple jobs held for less than one year

Interview process:
Two interviews, possibly three - video conference

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Product Development, Process Design & Experimentation - Hybrid (JP14756) - Thousand Oaks, CA

Tue, 18 Nov 2025 12:07:13 GMT

Job Title: Engineer, Drug Product Development, Process Design & Experimentation - Hybrid (JP14756)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 11/18/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. Hybrid - 2-3 days onsite per week. Flexibility for more onsite requirements may be necessary.

3 Key Consulting is hiring an Engineer, Drug Product Development, Process Design & Experimentation - Hybrid for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This is a hybrid position. 2-3 days onsite per week. Must have flexibility for more onsite work if necessary.

Our ideal candidate will have a B.S. and 2YOE in Pharma with drug product experience

As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Good documentation practices (GDP)
Experience with visual inspection
Technical writing skills

Day to Day Responsibilities:

Supports the establishment of robust tactical and strategic objectives related to visual inspection
Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect panels, establishment of GMP procedures related to operations)
Implements and documents off-line and on-site drug product characterization studies
Author and/or own high-quality process technology transfer and other technical documents
Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
Support one or more clinical and commercial process introductions or process transfers into client manufacturing network

2+ years of experience within the pharmaceutical/biotechnology industry
Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters
Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
Ability to learn and act on dynamic information at a rapid pace
Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
Strong knowledge of quality systems and drug product manufacturing
Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
Capable of organizing and communicating complex technical concepts to enable business decisions

Red Flags:
No prior Pharma or Biotech experience.

Interview process:

2 interviews (manager and team)

Video via Microsoft Teams

Engineer, Parenteral Drug Product Process Development, Testing & TT (JP14749) - Thousand Oaks, CA

Wed, 12 Nov 2025 14:44:30 GMT

Job Title: Engineer, Parenteral Drug Product Process Development, Testing & TT (JP14749)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 12+ months (with likely extensions and/or conversion to permanent)
Posting Date: 11/12/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring an Engineer, Parenteral Drug Product Process Development, Testing & TT for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
We are seeking a skilled Process Development Engineer who can work independently to support technical projects. The ideal candidate will have expertise in laboratory testing, drug product fill finish processing, holistic drug product process knowledge, technical transfer, and drug product manufacturing. Excellent communication skills and proficiency in technical writing are essential for this role.

Author, data verify, and review guideline documents, technical protocols, reports, product impact assessments.
Execute laboratory analytical testing such as: viscosity, protein concentration, pH, osmolality.
Execute laboratory experiments such as pipetting, formulation, filtration.
Provide technical support for drug product process development, including formulation, filtration, and filling (vials/syringes/devices) of parenteral products.
Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.
Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Post graduation experience required.
Laboratory experience using analytical equipment
Evidence of good communication e.g. writing documents and sharing results.
Evidence of good communication e.g. writing documents and sharing results.
College degree in engineering or similar (chemical engineer, bio engineer, pharmaceutical science, etc.).

Day to Day Responsibilities:
1. on site laboratory work, for example testing viscosity with a rheometer
2. maintaining good documentation practices with a laboratory notebook
3. analyzing and summarizing results to be communicated out
4. documentation and data verification

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:

No recent relevant experience with analytical equipment
Poor communication / organization in resume

Interview process:

Short phone screen with manager

Panel interview with co workers virtual
Possible final interview with associate director of organization virtual

Engineer Senior, Electromechanical, Biotech Medical Device - Hybrid (JP14738) - Thousand Oaks, CA

Thu, 06 Nov 2025 16:21:59 GMT

Job Title: Engineer Senior, Electromechanical, Biotech Medical Device - Hybrid (JP14738)
Location: Thousand Oaks, Ca. (3-5 days onsite)
Business Unit: Electromechanical Platform
Employment Type: Contract
Duration: 1 years with likely extension or conversion to perm
Rate: $42-52/hours W2 with benefits
Posting Date: 11/06/2025
Target Start Date: 01/05/2026

3 Key Consulting is hiring! We are recruiting a Senior Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate:
Seeking candidates with experience in combination products, electromechanical systems, or medical devices, a background in pharma, and hands-on expertise in design control

Job Description:
The Sr. Engineer will lead and support design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.

Preferred Qualifications:

Master’s or Bachelor’s Degree in Engineering Discipline (Mechanical, Biomedical, Electrical) with 5-7 years (or 3-5 years with Masters) of professional experience in highly regulated environment (strong preference for medical device, biopharma and/or combination product experience).
Experience with electromechanical systems, injection devices, or delivery platforms preferred.
Demonstrated expertise in design verification testing, data analysis, and protocol/report generation under design control.
Strong understanding of materials coordination, supplier interaction, and lab testing logistics.
Proven ability to work in cross-functional project teams, communicate technical results clearly, and lead execution to meet program milestones.
Working proficiency in statistical analysis software (Minitab)
Smartsheets proficiency is a plus.
Ability to work independently and dynamically across functional teams
Excellent written and verbal communication skills
Ability to work on-site in Thousand Oaks full-time (3-5 days/wk).
Must be capable of working on multiple projects in a deadline driven environment.

Top Must Have Skill Sets:

Expertise in design control and quality systems (21 CFR 820.30, ISO 13485) with proven ability to plan, execute, and document design verification and validation for combination products.
Hands-on capability in testing electromechanical systems, including data collection, statistical analysis, and performance evaluation.
Proven ability to partner effectively with R&D, Quality, Regulatory, and Manufacturing teams.
Nice to have: Minitab, Smartsheet, and supplier interaction experience

Day to Day Responsibilities:

Provide design verification support for combination products, ensuring compliance with Quality System Requirements, Design Control (21 CFR 820.30), and ISO 13485.
Lead and execute on-site testing and verification activities for electromechanical delivery systems and related platforms.
Develop, review, and execute test protocols, reports, and technical documentation in accordance with design control and regulatory expectations.
Perform data verification, analysis, and traceability reviews to ensure product performance meets user needs and design inputs.
Manage materials and maintain traceability of material inventory at Thousand Oaks to support various design control activities. Additionally, support supply of the materials as required to internal and external sites.
Partner cross-functionally with R&D, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.
Support control plans, requirements management, and risk management activities (DFMEA, PFMEA) as part of design verification strategy.
Contribute to continuous improvement of test methods, design verification processes, and documentation practices in line with Company’s device development framework.
Manage change assessments driven by internal and external changes during the life cycle of the combination product
Participate in and support cross-functional design reviews for combination product development.
Ability to work on-site in Thousand Oaks full-time (3-5 days/wk).

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience.

Red Flags:

Lack of experience in hands-on testing in laboratory environments
Unable to be consistently on-site in Thousand Oaks
Low motivation/engagement at prospect of working with medical device and/or combination products
Poor written and verbal communication
Entry level or too experienced - hands on work is required and a strong eagerness to grow is required.

Interview Process:
1:1 with hiring manager - Virtual
1:3 (or 1:2) with prospective team members - Virtual

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Container Closure Integrity Design, Testing & Equipment Validation (JP14727) - Thousand Oaks, CA

Thu, 06 Nov 2025 13:33:57 GMT

Job Title: Engineer – Container Closure Integrity Design, Testing & Equipment Validation (JP14727)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Physical Methods Development, Modelling and Emerging Methods
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 11/05/2025
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. Onsite with some “work from home” flexibility.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Onsite in Thousand Oaks, CA. at least 2x/ week. Candidate must be within commutable distance and must be able to come on site 5 days a week if needed.

Bippharm or Biotech experience and/or Equipment Validation experience within another industry. Position is split between lab and office.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for container closure integrity testing (CCIT) related scope.
Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution.
Assist with project definition by performing engineering studies and assessment for CCIT system installations.
Perform field evaluations of existing systems and provide engineering design recommendations and support development of CCIT technologies.
Equipment qualification- Equipment validation is a highly desired skillset. Will be working with other associates on testing and conducting testing themselves.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Solid modeling (SolidWorks - preferred)
Technical Writing
Working in a team

Day to Day Responsibilities:
Day to day activities will include supporting development of technical documentation related to CCI testing, execution of protocols to support development, writing of technical documentation to support findings and results. Heavy on documentation and manual disassembly role. Additional activities will include:

Documentation writing (procedures, technical assessments, engineering drawings, etc)
Solid modeling (fixture development)
Meetings
Testing
Device Disassembly

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience

Red Flags:

Less than a bachelors degree
A non-STEM bachelors degree
No work experience (internship okay)

Interview process:
Initial phone call
Panel interview (2-3 people on call)

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Principal – Drug Substance Manufacturing Process Optimization & Tech Transfer (REMOTE) (JP14711) - Holly Springs, NC

Tue, 28 Oct 2025 17:20:52 GMT

Job Title: Engineer Principal – Drug Substance Manufacturing Process Optimization & Tech Transfer REMOTE (JP14711)
Location: Holly Springs, NC. 27540 (Remote but all job seekers need to commit to two weeks on-site during critical operations and should be local/ willing to travel to Holly Springs, NC. Campus)

Employment Type: Contract
Business Unit: Drug Substance Technology Business Operations
Duration: 6+ months (with likely extensions and/or conversion to permanent)
Posting Date: 10/28/25
Pay Rate: $55 - $62/hour W2
Notes: Only qualified candidates need apply. Remote but all job seekers need to commit to two weeks on-site during critical operations and should be local/ willing to travel to Holly Springs, NC. Campus

3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Remote but all job seekers need to commit to two weeks on-site during critical operations and should be local/ willing to travel to ANC campus

Lead optimization of drug substance processes related to pharmaceutical manufacturing technology transfer. Lead sub-teams and provide expertise to support drug substance manufacturing. Provide support for technical troubleshooting in a GMP environment, investigations, and deviation/CAPA strategy. Candidate should be proficient in process monitoring tools, data visualization tools (e.g., Spotfire), and GMP principles. Candidate needs to travel periodically to the manufacturing site for critical activities. Candidate will need to provide second shift process monitoring as needed.

Provide technical leadership for cross functional project teams working on complex business challenges, communication of work through presentations, and authorship and review of documentation.
The candidate will be expected to keep current on the latest industrial, scientific, business, and regulatory trends.
Build and maintain effective collaborations with partner organizations across client’s Process Development and Operations Networks.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Proficient in tech transfer
Proficient in MFG Support
Able to lead sub-teams and provide expertise for technical troubleshooting

Day to Day Responsibilities:

Lead optimization of drug substance processes related to pharmaceutical manufacturing technology transfer.
Lead sub-teams and provide expertise to support drug substance manufacturing.
Provide support for technical troubleshooting in a GMP environment, investigations, and deviation/CAPA strategy.
Candidate should be proficient in process monitoring tools, data visualization tools (e.g., Spotfire), and GMP principles.
Candidate needs to travel periodically to the manufacturing site for critical activities.
Candidate will need to provide second shift process monitoring as needed.

Basic Qualifications:
Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience

Employee Value Proposition:

Unique industry opportunity
Career growth
Networking

Red Flags:

Lab experience only
Unwilling to travel
Unwilling to work outside day shift

Interview process:
Video conference interview with hiring manager

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Biotech GMP Drug Substance manufacturing, tech transfer – Remote (JP14709) - Holly Springs, NC

Tue, 28 Oct 2025 17:08:17 GMT

Job Title: Engineer Senior, Biotech GMP Drug Substance manufacturing, tech transfer – Remote (JP14709)
Location: Holly Springs, NC. 27540
Employment Type: Contract
Business Unit: DST Business Operations
Duration: 6+ months with likely extensions and/or conversion to permanent
Posting Date: 10/28/2025
Pay Rate: $45 - $50/hour W2 with benefits
Note: Remote but all job seekers need to commit to two weeks on-site during critical operations and should be local/ willing to travel to campus

3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Provides expertise and leadership to support GMP Drug Substance manufacturing, tech transfer, technical problem solving, and process improvements and investigations. Candidate should be proficient in process monitoring tools, data visualization tools (e.g., Spotfire), and GMP principles. Candidate needs to travel periodically to the manufacturing site for critical activities.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Proficient in GMP manufacturing support
Proficient in Tech Transfer
Proficient in Drug Substance processes

Day to Day Responsibilities:
Provides expertise and leadership to support GMP Drug Substance manufacturing, tech transfer, technical problem solving, and process improvements and investigations. Candidate should be proficient in process monitoring tools, data visualization tools (e.g., Spotfire), and GMP principles.

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience

Employee Value Proposition:
Unique industry opportunity
Career growth
Unique industry experience

Red Flags: Lab experience only

Interview process:
Phone interview with hiring manager

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Biotech - Synthetics/Small Molecule Processes (JP14658) - Thousand Oaks, CA

Mon, 20 Oct 2025 12:40:00 GMT

Job Title: Engineer, Biotech - Synthetics/Small Molecule Processes (JP14658)
Location: Thousand Oaks, Ca 91320
Business Unit: DTS Synthetics
Employment Type: Contract
Duration: 1+ years with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 10/20/2025.
Notes: Fully Onsite - Lab Based - Standard Hours

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate:
M.S. or B.S. with 2+ years of experience
Lab experience in synthetic chemistry (small molecules preferred)
Bonus: Experience with data automation

Job Description:
In this dynamic role you will be managing activities in the High-Pressure Development Lab (HPDL), supporting high throughput experiment (HTE) solubility/crystallization screening work, and HTE reaction screening automation workflows within the Drug Substance Technologies – Synthetics (DSTS) group. These workflows support activities across all stages of process development in the synthetics portfolio, including route selection, process optimization, and process characterization. The candidate will work under the supervision of the HPDL and HTE Owners and will be onsite lab support.

Responsibilities for this role include:

Management of high-pressure reactors in the HPDL and provide hands-on training and oversight to the users of the equipment.
Advancement of automation capabilities for HPDL/HTE lab equipment and data management.
Author, review, and approve of documentation needed for equipment management and experimental activities.
Lead lab inventory management including monitoring usage, ordering, and restocking of consumables.
Monitor training compliance and participate in EHSS risk assessments.
Design, execution, and interpretation of HTE solubility/crystallization screening activities including solid-state characterization (XRPD, DSC/TGA, HPLC and similar methods) to support project teams.

Preferred Qualifications

An ideal candidate has a bachelor’s degree in chemical engineering or chemistry with 2 years of synthetic lab experience.
Command of chemical lab operations and associated safety practices.
Ability to work in a team environment, collaborating with various colleagues in process development including process chemists and analytical chemists, as well as cross-functional collaboration with Environmental, Health, Safety, & Sustainability, Facilities & Engineering, lab management, and third-party vendors.
Experience with X-ray powder diffraction (XRPD) or thermal analysis (DSC/TGA) is a plus.
Interest, skills, and motivation for advancing lab activities and management with wide impact.
Demonstrated ability to work independently in a fast-paced team environment to ensure continuity, efficiency, and reliability of lab operations.
Excellent presentation, written and verbal skills.
Knowledge of basic office software including Microsoft Word, Excel, PowerPoint, and Outlook.

Top Must Have Skill Sets:
• Lab expertise
• Data logging/automation
• Communication

Day to Day Responsibilities:
Routine user support for experiments:

Act as superuser of all high-pressure development equipment.
Provide hands-on training and oversight for new users and refresher training to previous users.
Represent organization within a multi-functional team to ensure deliverables are aligned with timeline, such that key achievements are established and achieved.
Author, review, and/or approve of process documentation needed for equipment management and experimental activities.

Equipment upkeep and maintenance:

Coordinate equipment scheduling for new experiment requests.
Submit work orders, independently manage equipment maintenance and support equipment troubleshooting.
Support preventative maintenance operations related to lab equipment and utilities
Monitor reactive gas inventory, coordinate gas reservoir refills and cylinder replacements.
Lead lab inventory management including monitoring usage, ordering, and restocking of consumables.
Establish management system for equipment replacement parts and maintain stock.
Expertise with lab equipment handling and repair to troubleshoot challenges.

Lab improvements and knowledge management format:

Support authoring of training documentation for lab operations and equipment.
Monitor training compliance and coordinate training refreshers through company training system.
Participate in and curate content for core and steering team meetings.
Work closely with process development chemists and engineers to generate and interpret data to provide improved understanding and guidance.
Lead efforts to upgrade aging equipment (100 mL EasyMax and 5 L Buchi)
Identify scope and implementation plan for retrievable data logging (pressure, temperature, and gas uptake) from equipment
Identify HTE activities that can be automated and minimize manual intervention

Interview Process:
2 interviews for a candidate: one hour panel and then half an hour call with director

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Engineer – Biotech, Drug Delivery Device & Packaging (JP14628) - New Albany, Ohio

Wed, 15 Oct 2025 13:26:18 GMT

Job Title: Senior Engineer – Biotech, Drug Delivery Device & Packaging (JP14628)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Duration: 2 years with possible extensions and/or conversion to permanent
Posting Date: 10/15/2025
Pay Rate: $50 - $54/hour W2
Notes: Onsite Ohio - 5 days a week. Schedule is typically 8am - 5pm (some flexibility with schedule, may be expected to work OT 10% of the time during peak season).

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: Experience: Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products.
Skills: Strong English written and verbal communication skills, MS Office, SmartSheet (project scheduling software), project management experience in a supporting role.
Desired: Engineering Background

Job Description:
In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.

Responsibilities include:

Supporting and creating project schedules, lead site assessment and manufacturing capabilities, update project dashboards, and leading team meetings to progress the project towards final objectives. You will work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members.
Your role will focus on leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.
Supporting New Product Introduction to company manufacturing site.
Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.
Supporting engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.
Developing, tracking, and providing project dashboard updates.
Providing good communication plans to cross-functional teams and Process Engineer management.
Ability to apply project management and engineering science to production.
Strong teamwork and excellent interpersonal and communication skills.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

4- 5 years of experience post-graduation
Tech Transfer
Engineering
Project Management

Basic Qualifications:
Master’s degree OR Bachelor’s degree and 2 years of experience OR Associate’s degree and 6 years of experience

Preferred Experience:

Experience in the Tech Transfer of Combination Product field, focusing on project management and/or manufacturing.
Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes.
Knowledge of Combination Product design controls and regulatory requirements on a global scale.
Familiarity with Company’s commercialization framework.
Program and Project Management skills (experience with MS Project, SmartSheets, and other project scheduling software is desired).

Additional Skills:

Proactive risk assessment, management, and mitigation.
Ability to lead and succeed in an ambiguous environment.
Strong project management skills.

Red Flags:

This is not a Project Manager role, it is an engineer role with project management skills
This position does not include relocation package
Prefer candidates in Ohio - Columbus/New Albany

Interview process:
- First interview with me (Hiring Manager) - 30 min
- Second interview with Omar Noorzai and Sofia Espinell (Interview Panel) - 45 min
- Third interview with Daniel Davila and Ahmad Kamel (Interview Panel) - 45 min

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Biotech, Drug Delivery Device & Packaging (JP14627) - New Albany, Ohio

Wed, 15 Oct 2025 13:20:50 GMT

Job Title: Engineer – Biotech, Drug Delivery Device & Packaging (JP14627)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Duration: 2 years with possible extensions and/or conversion to permanent
Posting Date: 10/15/2025
Pay Rate: $40 - $44/hour W2
Notes: Onsite Ohio - 5 days a week. Schedule is typically 8am - 5pm (some flexibility with schedule, may be expected to work OT 10% of the time during peak season).

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: Experience: Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products.
Skills: Strong English written and verbal communication skills, MS Office, SmartSheet (project scheduling software), project management experience in a supporting role.
Desired: Engineering Background

Job Description:
In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.

Responsibilities include:

Supporting and creating project schedules, lead site assessment and manufacturing capabilities, update project dashboards, and leading team meetings to progress the project towards final objectives. You will work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members.
Your role will focus on leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.
Supporting New Product Introduction to company manufacturing site.
Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.
Supporting engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.
Developing, tracking, and providing project dashboard updates.
Providing good communication plans to cross-functional teams and Process Engineer management.
Ability to apply project management and engineering science to production.
Strong teamwork and excellent interpersonal and communication skills.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

1- 2 years of experience post-graduation
Tech Transfer
Engineering
Project Management

Basic Qualifications:
Master’s degree OR Bachelor’s degree and 2 years of experience OR Associate’s degree and 6 years of experience

Preferred Experience:

Experience in the Tech Transfer of Combination Product field, focusing on project management and/or manufacturing.
Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes.
Knowledge of Combination Product design controls and regulatory requirements on a global scale.
Familiarity with Company’s commercialization framework.
Program and Project Management skills (experience with MS Project, SmartSheets, and other project scheduling software is desired).

Additional Skills:

Proactive risk assessment, management, and mitigation.
Ability to lead and succeed in an ambiguous environment.
Strong project management skills.

Red Flags:

This is not a Project Manager role, it is an engineer role with project management skills
This position does not include relocation package
Prefer candidates in Ohio - Columbus/New Albany

Interview process:
- First interview with me (Hiring Manager) - 30 min
- Second interview with Omar Noorzai and Sofia Espinell (Interview Panel) - 45 min
- Third interview with Panel - 45 min

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Principal, Drug Delivery Medical Device Process Development - (JP14606) - New Albany, Oh

Fri, 10 Oct 2025 18:03:00 GMT

Job Title: Engineer Principal, Drug Delivery Medical Device Process Development - (JP14606)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process development
Duration: 1+ years with possible extension or conversion to FTE
Posting Date: 10/10/2025
Pay Rate: $50 - $56/hour W2 with benefits
Notes: Only qualified candidates need apply. Onsite AOH - Monday - Friday - Standard 8-5. Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month. Also, CANDIDATES MUST BE ABLE TO TRAVEL INTERNATIONALLY.

3 Key Consulting is hiring an Engineer Principal, Medical Device Process Development, for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate will have 10 years of experience. (See below for details). This position will be onsite in New Albany, OH., Monday - Friday - Standard 8-5. Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month.

The qualified candidate will lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Responsibilities:

Work cross-functionally with individuals and project teams in Marketing, Operations, and Development - Create and assess product requirements to determine technical coverage and proper integration different subsystems.
Create and execute to project plans and schedules
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Provide deep technical assistance for junior engineers.

Why is the Position Open?
Planned Project

Top Must Have Skills:
The Principle Engineer will work closely with team members to focus on the following skills:

Develop, execute, and design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Strong problem solving, risk assessment, and risk management skills and capable of working on multiple projects in a deadline driven environment.

Day to Day Responsibilities:
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. In addition to troubleshoot new equipment to be implemented.

Basic Qualifications:
Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience.

BS in Engineering and previous experience in a medical device industry
10 years current experience with engineering processes and procedures.
Led projects from development through the 510k and PMA approval process.
Strong background in engineering and commercialization of electro-mechanical medical devices.
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in drug/device combination product design and development
Familiar with the following standards:
- Quality System Regulation 21CFR820
- Risk Management ISO 14971
- EU Medical Device requirements Council Directive 93/42/EEC
- Medical Electrical Equipment EN 60601
Small scale device assembly experience.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Strong problem solving, risk assessment, and risk management skills.
Must be capable of working on multiple projects in a deadline driven environment.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered.

Red Flags:
Not flexible for the working shift/hours required. Approximately 1-2x per month

Interview process:
One round panel interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Validation Engineer – Cold Storage & Analytical Equipment - (JP14626) - Thousand Oaks, CA

Fri, 10 Oct 2025 14:29:34 GMT

Job Title: Validation Engineer – Cold Storage & Analytical Equipment - (JP14626)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Final Product Technologies Development
Duration: 12+ months (with likely extensions and/or conversion to permanent)
Posting Date: 10/10/25
Pay Rate: $45 - $55/hour W2
Notes: Only qualified candidates need apply. Fully onsite. Local candidates only

3 Key Consulting is hiring a Validation Engineer – Cold Storage & Analytical Equipment for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
We are looking for candidates with experience in:

Cold Storage Validation Experience
Analytical Equipment experience
Preferably Lab Ops/Equipment Background
Drafting Documents

Primarily responsible for ensuring adherence to computer validation standards and procedures for computer-related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

Why is the Position Open?
Unplanned Project.

Top Must Have Skills:

Strong and clear communication skills
Paying attention to details
Drafting documentation
Nice to specifically have cold storage and computerized Analytical Equipment familiarity
Ability to switch on different project at the same time
Can work as a team player and independently

Day to Day Responsibilities:
This role is responsible for ensuring compliance with cold storage validations, computer validations for analytical laboratory instruments, and supporting ad hoc laboratory operations projects. Key duties include participating in system design, preparing and executing test protocols, analyzing results, and generating summary reports. The position provides guidance on IT compliance and quality documentation standards, serves as a liaison between laboratory, IS, and Quality functions, and ensures timely resolution of issues during installation and qualification activities. Success in this role requires strong communication and multitasking skills, the ability to follow established procedures, and the flexibility to work independently as well as within a team. Onsite presence is required.

Basic Qualifications:
Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experience

Employee Value Proposition:
Industry experience.

Red Flags:

Not local or able to be onsite
No experience with drafting documents or any type of general Lab Operations
Not able to work in a fast-faced environment

Interview process:
Interview with hiring Manager and team via MS Teams online

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, GMP Biotech Process Tech transfer (JP14599) - Thousand Oaks, CA

Mon, 06 Oct 2025 15:38:40 GMT

Job Title: Engineer, GMP Biotech Process Tech transfer (JP14599)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Process Engineering
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 10/6/2025
Pay Rate: $36 - $41/hour W2 with benefits

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Basic Qualifications:
Master's Degree - 0 -2 years industry experience
Bachelor's Degree - minimum of 2 years industry experience

Nice to have:
Tech transfer experience
Preferably from BioPharma Industry

Job Description:
Ideal candidate: The ideal candidate for this role should have a bachelor’s degree in any scientific or engineering discipline with 1 – 3 years professional working experience. Candidates with recent Master degree are also suitable if they bring strong soft skills.

The candidate should possess solid working experience with standard software tools such as Microsoft Office. Experience with specialized software such as SAP or Smartsheet is desirable but can be learned on the job. Biologic drug product knowledge is favorable. The candidate must excel in group management, deadline adherence, and meticulous documentation skills. This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop over time. Professional working experience outside of an academic setting is preferred.

As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at Thousand Oaks, CA which includes various production lines. The candidate will support senior staff in the planning, execution, and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for supporting execution of characterization studies to generate technical data packages using complex technology, organization of data and analysis of results, and compiling information in concise summaries while under supervision of senior staff. The candidate will coordinate with drug product teams to facilitate technology transfer and complete technical documentation. The candidate will assist with experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups.

Preferred Qualifications:

B.S. in scientific or engineering discipline with 1‒3 years’ relevant professional experience or M.S. in scientific or engineering discipline with 0‒2 years’ relevant professional experience
Familiarity with cGxP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displays critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Chemical Engineering, Biotechnology, and Pharmaceutical Science Industry related experience
Has been working on GMP environment
Preferably from BioPharma Industry

Responsibilities include, but are not limited to, the following:

Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
Support development and maintenance of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Conduct analysis of data generated, including statistical analysis using applicable software.
Development of digital tools and models by leveraging data analytics and programming skills
Support at scale characterization and/or process validation runs as person in plant

Red Flags:

Job Hopper
Someone who have performance issues on previous employment
Not committed to work and not willing to learn

Interview process:
Phone screening by hiring manager and panel interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Tech Engineer I, Lab Support Drug Delivery Devices (JP14478) - Thousand Oaks, CA

Tue, 30 Sep 2025 14:30:22 GMT

Job Title: Associate Tech Engineer I, Lab Support Drug Delivery Devices (JP14478)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: D&FDPT Lab Management
Duration: 2+ years (with likely extensions and/or conversion to permanent)
Posting Date: 08/29/25
Pay Rate: $32 - $34/hour W2, Or Market Rate DOE with benefits
Notes: Recent college grads welcome. Onsite 8am-5pm PST

3 Key Consulting is hiring an Associate Tech Engineer I for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Role will support and prioritize the following work in multiple labs involving primary and secondary containers, device engineering, packaging and labeling, human factors, and transportation of final products.
• Laboratory organization and inventory maintenance
• Medical waste management
• Laboratory safety and compliance
• GMP & non-GMP equipment preventative and general maintenance
• Equipment operation & administration
• Implementation new technology
• Coordination with outside vendors

Top Must Have Skills:
1 - Actionable ability to listen (read), learn, and communicate clearly
2 - Capable to prioritize, organize, track, and complete projects and assignments
3 - Fundamental computer knowledge related to common applications such as Windows, Browsers, and MS-Office

Day to Day Responsibilities:
• Intake & organize new assignments & tasks
• Process incoming and ongoing material storage and equipment usage requests throughout lifecycle
• Audit cold storage and dry storage resources.
• Wrap/unwrap pallets
• Label material, equipment, and lab spaces
• Communicate and coordinate with vendors
• Update inventories
• Stay up to date with training assignments
• Laboratory inspections & consumable restocking

Basic Qualifications:

Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Engineering or biotechnology background
Enthusiasm for new technology (digital and mechanical)
Continuous improvement mindset
Clear communication and presentation skills

Employee Value Proposition:
Good potential for learning & growth, with possible conversion to FTE.

Interview process:
1 Phone Screen, 1 Panel In Person (or virtual)

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Delivery Device Complaints and Investigations (JP14565) - Thousand Oaks, CA

Wed, 24 Sep 2025 11:16:55 GMT

Job Title: Engineer, Drug Delivery Device Complaints and Investigations (JP14565)
Location: Thousand Oaks, CA. 91320 - Hybrid
Business Unit: Complaints Investigation
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $38 - $42/hour W2 with benefits
Posting Date: 09/24/2025

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Sr. Engineer in Complaints Trending and Investigation group. In support of company’s mission to serve patients, the Complaints Trending and Investigation group at company is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The complaints investigation technical investigator will perform the device assessment of complaint samples using lab equipment such as the CT scanner and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis, as well as supporting/leading root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Responsibilities include:

Perform device assessments of complaints and document results in a report.
Complete evaluation and deliver assessment report on time per company requirements.
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
Support characterization testing and data gathering for investigations
Perform root cause analysis investigations for mechanical and/or electromechanical products

Top Must Have Skill Sets:

Technical background preferably in a GxP setting
Laboratory experience- comfort with technical testing
Strong technical writing and interpersonal skills

Preferred Qualifications:

Master’s or Bachelor’s in Engineering, Science or Biomedical
2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience in lab environment
Demonstrated competency in root cause analysis methodology
Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented
Strong Sense of Responsibility and Time Management.

Basic Qualifications:
Master’s degree and 3 years of related medical/biopharma development or Operations experience; OR Bachelor’s degree and 5 years of related medical/biopharma development or Operations experience

Preferred Qualifications:

Bachelor’s, Master’s or PhD in Engineering, Science or Biomedical
2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience with statistics and statistical analysis
Demonstrated competency in root cause analysis methodology
Experience with protocol and report writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented team leader

Why is the Position Open?
Supplement additional workload on team

Red Flags:

Not a local candidate i.e. inability to come on site in Thousand Oaks, CA most days of week
Non-technical background
Poor Communication Skills

Interview Process:
Virtual Interview
- Interview with Hiring Manager
- Panel Interview with team

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Associate Director – Start-Lead New Drug Substance Facility (JP14556) - Holly Springs, NC

Tue, 23 Sep 2025 15:40:48 GMT

Job Title: Engineer Associate Director – Start-Up Lead New Drug Substance Facility (JP14556)
Location: Holly Springs, NC. 27540 (REMOTE with up to 25% travel to Holly Springs, NC.
Employment Type: Contract
Business Unit: DST Business Operations
Duration: 9+ months (with likely extensions and/or conversion to permanent)
Posting Date: 09/23/25
Pay Rate: $82 - $92/hour W2 with benefits
Notes: Only qualified candidates need apply. Remote- up to travel 25% to holly springs, NC

3 Key Consulting is hiring an Engineer Associate Director for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Candidates will be thoroughly screened for their experience and basic qualifications. We are NOT looking for an SME in a specific area but instead an independent experienced leader who can come into a new and upcoming site with a broad spectrum of knowledge and experience to be utilized amongst site teams

Highly versatile and experienced subject matter expert able to contribute as an individual or to lead teams across a wide range of drug substance technical areas.

Responsible for aspects of the successful preparation, strategy, and execution of Technology Transfer, Process Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ) during the start-up a of new Drug Substance production facility.
Responsible for enabling CMC Regulatory file drafting and support, commissioning and qualification of equipment, utilization of process models, process characterization, and process optimizations and troubleshooting.
The qualified candidate will lead technical teams across various disciplines and objectives.
Additional Responsibilities:
- Work cross-functionally with individuals and project teams in Process Development, Manufacturing, Quality, and Facilities and Engineering;
- Create and assess process technical assessments to support deviations and validations;
- Create and execute to project plans and schedules;
- Develop, execute, and review technical documents, validation documents, specifications, development plans, characterization plans, and verification and validation plans
- Provide deep technical assistance for junior engineers.

Why is the Position Open?
Planned project.

Top Must Have Skills:

Candidates must have experience and basic qualifications. We are NOT looking for an SME in a specific area but instead an independent experienced leader who can come into a new and upcoming site with a broad spectrum of knowledge and experience to be utilized amongst site teams.
**Broad set of expertise** across DS with extensive experience, including:
- Technology Transfer
- Process Scale-up
- Clinical & Commercial Manufacturing Support
- Process Performance Qualification (PPQ)
- CMC Regulatory file drafting and support
- Commissioning and qualification of equipment
- Utilization of process models
- Process characterization, and process optimizations and troubleshooting.

(Essentially someone at Principal Engineer or Director level in their current role)

Strong technical and management skills, will need to deliver as an individual and team lead
Strong collaborations skills, track record of team environment success

Day to Day Responsibilities:
Lead or contribute teams in areas above, delivering the required business result.

Basic Qualifications:
Basic Qualifications:
Doctorate degree and 3 years of experience
OR
Master’s degree and 7 years of experience
OR
Bachelor’s degree and 9 years of experience
OR
Associate’s degree and 12 years of experience
OR
High school diploma / GED and 14 years of experience

Employee Value Proposition:

Unique industry opportunity
Career growth

Red Flags:

Highly specialized in one drug substance (DS) area or no DS experience
No management experience
No experience supporting Manufacturing

Interview process:
Phone screen by EWC, Phone interview with hiring manager

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Metrology Engineer - (JP14574) - Thousand Oaks, CA

Tue, 23 Sep 2025 10:57:39 GMT

Job Title: Metrology Engineer - (JP14574)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Engineering Business Ops
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 09/23/25
Pay Rate: $62 - $67/hour W2
Notes: Only qualified candidates need apply. Fully onsite at Thousand Oaks, CA.

3 Key Consulting is hiring a Metrology Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This summary provides a detailed overview of the Metrology Engineer position, outlining the key responsibilities, qualifications, and expertise required. The role emphasizes strong calibration skills, particularly in gas flow, and demands experience in pharmaceutical metrology within regulated environments.

Top Must Have Skills:

The Metrology Engineer role requires a candidate with extensive gas flow calibration experience and the capability to design, install, and validate complex calibration and measurement systems with minimal supervision.
The position necessitates knowledge of GMP or GXP environments and expertise across multiple measurement disciplines, including pneumatic/fluid flow, pressure, electronics (AC/DC), and temperature.
The candidate is expected to collaborate with various departments and client's sites globally to implement a calibration control program.

Day to Day Responsibilities:

Develop calibration procedures and job tasks along with associated training materials.
Apply strong understanding of flow, electrical, torque, and temperature instrument standards.
Understand measurement uncertainty analysis for primary and working standards as well as process instrumentation.
Identify and determine new standards to support instrumentation and metrology calibrations.
Utilize technical troubleshooting skills for instrument standards.
Comprehend ISO and related standards such as ISO 9001, ISO 17025, and ANSIZ540 in calibration and quality contexts.
Conduct vendor quality audits of calibration service suppliers and manage vendor quality issues.
Experience with CMMS systems like SAP, Maximo and MOX, and interface with corporate facilities teams on calibration matters.
Provide technical consultation on measurement problems and lead technical project teams.
Support deviation investigations, reverse traceability assessments, and implement corrective and preventative actions related to calibration and measurement issues.
Assist in engineering and performance assessments for new technologies supporting standards, manufacturing, process development, and research equipment.

Basic Qualifications:

Master’s degree OR, Bachelor’s degree and 2 years of experience OR, Associate’s degree and 6 years of experience OR, High school diploma / GED and 8 years of experience

A minimum of ten years of experience in metrology engineering, preferably at a large company's primary standards laboratory or in a comparable technical role involving advanced measurement engineering principles and complex technical assignments.
Educational qualifications include a Bachelor or Master of Science degree in Electrical Engineering, Mechanical Engineering, or Physics.
At least seven years of engineering experience in pharmaceutical or aerospace metrology or related fields is required

This position demands a highly skilled engineer with deep expertise in metrology and calibration within regulated pharmaceutical settings, capable of leading technical projects and ensuring compliance with quality standards worldwide.

Employee Value Proposition:

Unique industry opportunity
Career growth
Networking

Interview process:
Video conference

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Engineer, Biotech GMP New Line Packaging Operations (JP14555) - New Albany, Ohio

Thu, 18 Sep 2025 12:34:32 GMT

Job Title: Senior Engineer, Biotech GMP New Line Packaging Operations (JP14555)
Location: New Albany, Oh 43054
Business Unit: Manufacturing Systems Engineering
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $65 - $85/hour DOE - W2 with benefits
Posting Date: 9/18/2025
Note: Candidates MUST be eligible to travel overseas for up to 16 weeks per year. Travel will be planned 2-3 weeks in advance. Fully Onsite - Standard Hours - Occasional overtime may be necessary on an as needed basis.

3 Key Consulting is hiring! We are recruiting a Senior Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: 4+ YOE, experience supporting a manufacturing line, and GMP or regulated environment experience.
Nice to have: relevant pharma experience, experience starting up a new manufacturing line.

Description:
In this role the Senior Engineer (Line Owner/System Owner) must work under general supervision, owns all the technical aspects in a manufacturing line. The processes where the SO/LO Engineer shall be familiar with are:

Characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects.
Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.
As a technical resource of an area, System owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. At the same time, the System Owner/Line Owner Engineer shall be able to define design requirements to the service providers to fulfill area technical and equipment needs.

Specific responsibilities include but are not limited to:

Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
Initiate and complete routine technical tasks.
Operations Engineering:
Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
Design Engineering:
Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects and engineering firms on development of standard design documents.
Acquire and critique quotes for equipment modifications or installations.
Generate rudimentary project cost estimates and schedules.

Top 3 Must Have Skill Sets:

Experience in a manufacturing environment, preferably GMP regulated or other highly regulated environment
Experience working hands-on to solve technical problems on manufacturing equipment
Great communication skills

Day to Day Responsibilities:

Act as the equipment technical subject matter expert for an end to end pharmaceutical device assembly and packaging line.
This individual is responsible for working with the maintenance and automation teams to resolve complex issues that are escalated beyond the technician level.
This individual also leads improvement projects to increase line OEE

Preferred Qualifications:

Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
Knowledge of pharmaceutical/biotech processes
Familiarity with validation processes for Packaging areas
Familiarity with serialization process and networking
Familiarity with documentation in a highly regulated environment
Ability to operate specialized equipment, tools and computers as appropriate.
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
Ability to apply engineering science to production.
Able to develop solutions to routine technical problems of limited scope
Comprehensive understanding of protocol requirements.
Organizational, project management, problem-solving, as well as validation protocol, and

Technical writing capability

Excellent communication (verbal/written) and presentation skills
Demonstrated interpersonal skills including; collaboration, influencing, and facilitation
Protocol and script testing Writing
Dealing with and handling change
Packaging Equipment Technical knowledge
Analytical Problem Solving
Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context

Basic Qualifications:
Doctorate degree and 1+ years of experience OR Master’s degree and 3+ years of experience OR Bachelors degree and 5 years of experience OR Associates degree and 8 years of experience

Red Flags:
Any time at companies shorter than 6mo, although the hiring team understands some contracts are shorter.

Why is the Position Open?
Supplement additional workload on team

Interview Process:
Round 1 - 1 on 1 interview with hiring manager
Round 2 - Panel interview with 2-3 engineers/managers

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer – Biotech Automation and Packaging Maintenance (JP14551) - New Albany, OH

Wed, 17 Sep 2025 16:11:48 GMT

Job Title: Associate Engineer – System/Equipment/Utilities Optimization & Maintenance (JP14551)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Systems Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 09/17/2025
Pay Rate: $25 - $30/hour W2
Notes: Only qualified candidates need apply. Shift details: 6 AM to 6:30 PM

3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
In this role, you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area in Non-Standard Shifts structure.

Fully onsite New Albany, OH
Shift details: Administrative shift 8am - 5pm M-F for approximately first 2-4 months
6pm - 6am thereafter (graves 15% shift differential)

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Understanding in PLC, HMI, Computer Serialization, Packaging Equipment, Inspection Systems
Experience with automation system hardware and software support, including installation, troubleshooting, machine breakdowns and preventative maintenance.
Strong communication skills: verbal / written, collaboration, influencing, and facilitation.

Day to Day Responsibilities:

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.
Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Support cGMP validation of equipment and processes.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and company policies.
Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for equipment/systems.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program troubleshoot and repair equipment/system failures.
Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
Support Operations using Current Good Manufacturing Practices (cGMP).
Support Operations in non-standard shifts that include weekends and/or holidays as determined by the business.

Basic Qualifications:

Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Employee Value Proposition:

Unique industry opportunity
Career growth
Networking

Interview process:
Virtual meeting
2 interviews
Can start interviewing immediately

Engineer Senior, Process Development GMP Packaging - (JP14502) - New Albany, OH

Tue, 16 Sep 2025 19:04:26 GMT

Job Title: Engineer Senior, Process Development GMP Packaging - (JP14502)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Advanced Assembly & Final Product
Duration: 2+ years (with likely extensions and/or conversion to permanent)
Posting Date: 09/16/25
Pay Rate: $42.00 - $46.00/hour W2
Notes: Only qualified candidates need apply. Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift

3 Key Consulting is hiring an Engineer Senior, Process Development GMP Packaging - (JP14502) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
*** This is a swing shift position - candidates need to have flexibility for different shifts. Dayshift / Nightshift

*** Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience,
technical writing & Document management system experience - Kneat or Viva preferred

The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, OH. This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on-site support and be able to work flexible schedule based on operation demands and both on-site work and ~20% travel

Key Functions & Outputs

Project Management:

Support technical transfer of product portfolio into the Ohio site.
Drive continuous improvement in device assembly and packaging line capacity/performance.
Communicate across the network to deliver technical milestones.

Technical Leadership:

Act as site expert in automated/semi-automated device assembly.
Lead commissioning, qualification, and validation (CQV) of GMP equipment.
Own and maintain the site master validation plan.

Operational Excellence:

Analyze, design, and implement manufacturing/business process improvements.
Drive productivity, throughput, and efficiency gains.

Quality and Document Management Systems:

Able to author and manage various documents/protocols/reports
Deviation/CAPA/EV Owner
Change Control Owner

Relationships:

Build networks with commercial and clinical operations.
Provide support for equipment standardization, troubleshooting, and performance trending

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:
Expertise in Combination Product Assembly & Packaging Equipment

Strong knowledge of automated and semi-automated device assembly, validation, and troubleshooting

Experience in GMP-Regulated Environments

Hands-on experience with technical transfer, regulatory compliance, and supporting commercial manufacturing operations

Cross-Functional Project Leadership & Communication Skills

Proven ability to lead technical projects, work across teams, and effectively communicate in a regulated, fast-moving industry
Strong technical writing skills.

Day to Day Responsibilities:

Serve as the technical lead for FDP assembly and packaging equipment (new and existing).
Manage commissioning, qualification, and validation activities for GMP equipment, including ownership of the site’s master validation plan.
Support technical transfer of new products into the site and ongoing optimization of packaging line performance.
Provide manufacturing troubleshooting and equipment/process improvements.
Build and leverage networks of technical experts across client’s global sites.
Support operational excellence initiatives to increase throughput, productivity, and efficiency

Basic Qualifications:

Doctorate (no experience required)
OR Master’s + 2 years GMP experience
OR Bachelor’s + 4 years GMP experience
OR Associate’s + 8 years GMP experience
OR High School/GED + 10 years GMP experience

Preferred Qualifications:

Combination product assembly equipment expertise
Cross-functional project leadership experience
Strong teamwork and communication skills
Direct experience in devices, combination products, and packaging operations
Supplier management experience (FDP equipment vendors)
Adaptability in regulated, fast-paced environments
Operational excellence / continuous improvement mindset

Red Flags:

Onsite Requirement: This is an on-site role in New Albany, Ohio.
Flexibility with Hours: While not explicitly stated as variable shifts, candidates should expect flexibility given the nature of GMP manufacturing, equipment commissioning, and troubleshooting demands.
Travel Requirement: Must be able to travel 20% required for this role
Candidate must be able to have great communication skills, project management, technical writing and be able adapt based on site priorities.
Too much experience - 8+ years and a B.S.

Interview process:
Virtual Teams Meeting

1:1 w/ Hiring Manager
1-2 Panel Interviews

Engineer, Biotech Downstream Process Equipment Maintenance - (JP14514) - Thousand Oaks, CA

Wed, 10 Sep 2025 18:24:57 GMT

Job Title: Engineer, Biotech Downstream Process Equipment Maintenance - (JP14514)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: F&E Drug Substance Supply.
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 09/10/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate:

B.S. 2-3+ YOE troubleshooting equipment.
Lead the troubleshooting and vendor support for a wide variety of process equipment that supports manufacturing.
Nice to have: PNID experience

Scope includes a wide range of devices such as Cleaning Systems (Autoclave, Glassware Washers, Dryers, CIP/COP), Single Use Systems (TFF, VI/VF, Chrom). SS Systems (TFF, VI/VF, Chrom, Columns, Tanks, Pumps), and miscellaneous equipment. The qualified candidate will work with the manufacturing and engineering team to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.

Why is the Position Open?
Coverage for partners leave of absence.

Top Must Have Skills:

GMP / FDA Background
Biotech / Pharma Equipment Troubleshooting Background
Cleaning Systems, Single Use Systems Experience

Day to Day Responsibilities:

Troubleshooting process equipment, coordinating PMs / Calibrations, etc.
Work cross-functionally with individuals and project teams in Engineering, Instrumentation, and Manufacturing.
Determine technical coverage and proper integration of different subsystems.
Provide deep technical assistance for other support staff and operators using equipment.

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
BS in Engineering, Biotech, Chemistry, or Equivalent and previous experience in a biotech/pharmaceutical industry with focus on usage and/or process equipment of specified equipment
2 years current experience with processes equipment troubleshooting and GMP procedures.
Strong background in troubleshooting, root cause analysis, and vendor coordination.
Must be capable of working on multiple projects in a deadline driven environment.

Red Flags:

No GMP / FDA experience
Not looking for operators
Candidates must have hands on troubleshooting experience

Interview process:
Phone Screen, potential panel

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Mechanical Design & Test Method Development (JP14414) - Thousand Oaks, CA

Thu, 04 Sep 2025 18:29:16 GMT

Job Title: Engineer – Mechanical Design & Test Method Development (JP14414)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Mechanical Design Engineering
Duration: 18+ months (with likely extensions and/or conversion to permanent)
Posting Date: 09/04/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. Thousand Oaks Local Candidates Only. Potential for Hybrid. 18 months with possible 18-month extension based on performance

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate is a junior to mid-level Mechanical or Biomedical Engineer (Bachelor’s degree, 1–3 years of experience, Master’s acceptable) with hands-on pharmaceutical or biomedical industry experience. They must demonstrate proficiency in statistical analysis, Gauge R&R, and optical measurement devices while having basic working knowledge of CAD/SolidWorks for simple designs. Strong familiarity with GMP documentation practices and ability to write technical documents is critical. The best fit will be local to Thousand Oaks or open to relocation, motivated to work in a hybrid on-site model, and able to show problem-solving ability and a willingness to learn.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. (See day-to-day responsibilities below).

The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions. This may include, but is not limited to, the following:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data
Network with manufacturing and quality organizations internal to client
Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
Monitoring technological developments in the field & evaluation of new technologies

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Statistical analysis, and knowledge of Gage R&R (Repeatability & Reproducibility)
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solid works, mechanical modeling

Day to Day Responsibilities:

Support FTE Engineers developing Methods and performing testing
Employs basic engineering skills and practices to gather user requirements and translate them into technical documentation.
Assist with project definition by performing engineering studies and assessment for automated test systems installations.
Perform field evaluations of existing systems and provide engineering design recommendations.
Create and revise documentations
Development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods.

Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solid works, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:

Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project, Smartsheet

Red Flags:

Zero experience with combination products, but willing to consider training a junior engineer.
No experience with combination products (e.g., injectors)
No GMP documentation experience
Candidates commuting from too far away (preference: local to Thousand Oaks or willing to relocate)
Overqualified candidates (6+ years pharmaceutical experience likely to leave quickly; PhDs too senior)

Interview process:
Phone screening with hiring manager, followed by final panel interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Project Implementation, New Equipment & Continuous Improvement - (JP14460) - Thousand Oaks, CA

Wed, 03 Sep 2025 12:08:56 GMT

Job Title: Engineer Senior, Project Implementation, New Equipment & Continuous Improvement - (JP14460)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Pilot Plant Engineering
Duration: 6+ months (with likely extensions and/or conversion to permanent)
Posting Date: 09/03/25
Pay Rate: $46 - $50/hour W2
Notes: Only qualified candidates need apply. Fully onsite position.

3 Key Consulting is hiring an Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate will have a B.S. and 5+ YOE, manufacturing project implementation, new equipment, regulated industry experience. Prior Pharma experience would be nice to have.

This role provides engineering support for projects and manufacturing activities, working in close collaboration with system owners, project teams, and cross-functional stakeholders. The Sr Engineer will leverage an engineering background to drive project implementation, continuous improvement initiatives, and system reliability. The role requires balancing technical problem-solving, project execution, and operational support, with a focus on compliance, safety, and business continuity. This position requires onsite support with occasional flexibility to cover after-hours engineering needs in support of 24/7 operations.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Project execution and management
Continuous Improvement
Analytical problem solving.

Day to Day Responsibilities:

Working in close collaboration with system owners, project teams, and cross-functional stakeholders
Partner with system owners, maintenance, project management, and manufacturing to ensure reliable operation and execution of equipment and systems.
Lead or support engineering-based improvements and capital projects, including requirements definition, design, construction, startup, and validation.
Drive continuous improvement by applying Lean principles, Six Sigma, and other methodologies to reduce costs, improve quality/safety, and increase operational efficiency.
Support commissioning, qualification, and performance verification activities for equipment and systems.
Provide oversight into contractors and vendor deliverables and ensure adherence to company standards.
Act as liaison between Engineering and Manufacturing during project planning, execution, and closeout.
Provide technical root cause analysis, troubleshooting, and problem-solving support to minimize downtime.
Support new product/technology introductions through engineering assessments and equipment modifications.
Ensure compliance with environmental health, safety, and regulatory requirements during all engineering activities.
Deliver coaching and guidance to project teams on commissioning, qualification, and process risk-based approaches.

Basic Qualifications:

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR associate’s degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Technical report writing, documentation, and presentations
Strong verbal and written communication
Organizational and change management skills
Analytical problem-solving and scientific/engineering reasoning
Experience with systems such as Maximo, TrackWise, E-Builder, PCS, BMS, and QEMS
Ability to manage multiple projects and troubleshooting activities simultaneously
Basic project management and cost estimation skills
Conflict resolution and cross-functional collaboration
Contractor and vendor management
Development of SOPs and training delivery
Customer service in a technical environment
Continuous improvement methodologies (Lean, Six Sigma, SPC, Predictive Maintenance)

Preferred Qualifications:

Bachelor’s degree in chemical, Mechanical, Electrical, or related Engineering field
6+ years of relevant engineering experience, with at least 5+ years in a biopharmaceutical or regulated manufacturing environment
Experience working in compliance-driven settings (e.g., cGMP, OSHA, EPA)
Direct knowledge of design, operation, and troubleshooting of GMP production equipment (e.g., chemical reactors, chillers, tablet press, dosage, clean utilities, etc.)
Demonstrated ability to apply engineering principles to system modifications, process improvements, and capital project execution
Knowledge of safety requirements and quality systems in a biopharmaceutical environment (change control, deviations, CAPA, validation)
Proven ability to lead and collaborate within cross-functional project teams
Strong leadership, technical writing, and presentation skills
Independent, self-motivated, organized, and able to adapt to dynamic project environments

Red Flags:
Large gaps in employment.

Interview process:
One Virtual panel, possibly two.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Delivery Device Laboratory Support - (JP14438) - Cambridge, MA

Fri, 29 Aug 2025 17:09:19 GMT

Job Title: Engineer, Drug Delivery Device Laboratory Support - (JP14438)
Location: Cambridge, MA. 02138
Employment Type: Contract
Business Unit: Combination Product Operations
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 08/29/25
Pay Rate: $37 - $41/hour W2
Notes: Only qualified candidates need apply. Onsite. Standard business hours, 8–5, no overtime expected.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This position reports into the Systems Engineering group in Cambridge, MA, supporting senior staff in performing general laboratory functions for the design and characterization of combination products as well as general laboratory support such as supporting preventive maintenance, calibration of lab equipment, and maintaining Good Laboratory Practices. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects. This position is expected to be at least 80% on-site.

The ideal candidate for the Engineer role at our client’s Cambridge site is an entry-level to early-career professional with a Bachelor’s in Biomedical, Mechanical, Electrical Engineering, or a related field (Master’s acceptable with limited experience) and 0–3 years of industry or internship experience.
This hands-on, lab-focused position supports combination product development through equipment testing and system characterization.
Candidates should demonstrate strong problem-solving and root cause analysis skills, proficiency in Good Documentation and Laboratory Practices (GDP/GLP), and familiarity with 3D modeling, Python scripting, and data analysis tools like JMP or Minitab.
The role requires the ability to perform lab testing, author technical reports, present findings, and work onsite. Reliability, adaptability, and a strong desire to learn are essential to supporting internal product development timelines.

Additional notes:

Exposure to 3D modeling (basic).
Comfort with Python scripting (basic, not expert level).
Familiarity with JMP/Minitab/data analysis tools – sufficient to run simple analyses.
Biomedical, electrical, or mechanical engineering background suitable (focus on lab equipment and systems engineering)

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Understanding of Good Documentation Practices and Good Laboratory Practices
Strong Problem Solving & Root Cause Analysis skills
Fast and continuous learner

Day to Day Responsibilities:

Perform hands-on engineering testing and experiments to characterize drug delivery systems in a controlled laboratory setting while following GLP and GDP.
Work in a laboratory environment, operating equipment such as 3D printers, tensile testers, viscosity testers, environmental chambers, arbor presses, and basic wet-lab equipment like transfer pipettes, micro pipettes, and balances.
Meticulously document experiment designs, material traceability, methods, techniques, results, and sample information in an Electronic Lab Notebook (ELN).
Perform basic data analysis using statistics, drawing relevant conclusions from study data and working closely with other staff to communicate and document these findings.
Author and execute protocols and technical reports summarizing key findings and results.
Assess & recommend optimized lab workflows and product designs.
Provide detailed data analysis and recommendations to enable senior staff to make informed decisions.
Be comfortable with thinking outside the box and being self-motivated to further add value to the organization.

Basic Qualifications:

Master degree OR Bachelor degree in an Engineering or Scientific Discipline and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Effective Communicator (Oral/Written)
Strong hands-on skills and a desire to work daily in a well-equipped laboratory environment
Methodical and thoughtful with a high attention to detail
Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

Preferred Qualifications:

Relevant experience (pharmaceutical industry, combination products, medical devices, etc.)
Wet lab & product testing experience
Understanding of Good Documentation Practices and Good Laboratory Practices
Statistics knowledge and data analysis skills (software: e.g. JMP, Minitab)
3D modeling and CAD experience
Basic programming skills (e.g. C, Python)
Organized and able to balance multiple concurrent priorities
Strong Problem Solving & Root Cause Analysis skills
Collaborative team player
Fast and continuous learner
Flexible/highly adaptive to changing priorities/environment

Red Flags:

Candidates with more than 5 years of experience.
Hesitation about onsite expectations
Excessive job hopping
Unexplained employment gaps
Resumes with vague descriptions, AI-generated buzzword content, or inability to speak to listed skills in interview

Interview process:

Manager (virtual)

Manager's manager & 1 team member

Associate Engineer, Clinical Mfg. and Lab Support Drug Delivery Devices - (JP14416) - Thousand Oaks, CA., California

Fri, 29 Aug 2025 16:30:12 GMT

Job Title: Associate Engineer, Clinical Mfg. and Lab Support Drug Delivery Devices - (JP14416)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: CPO Process Engineering
Duration: 2+ years (with likely extensions and/or conversion to permanent)
Posting Date: 08/29/25
Pay Rate: $32 - $34/hour W2
Notes: Only qualified candidates need apply. 100% On-site thousand oaks - possibility for some remote work after training. Schedule is 8am – 5pm, no overtime/holiday expectation. This position is on site and might require to travel depending on the project/program needs.

3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate for this position:

The Associate Engineer will hold a STEM degree in Mechanical, Biomedical, Biotech, or a related field and bring about 1-2 years of internship or professional experience in mechanical design, automation, process engineering, and root cause analysis.
This role requires strong documentation and report-writing skills alongside hands-on lab experience supporting clinical manufacturing and medical device tech transfers (e.g., syringes, auto-injectors).
Candidates should be entry-level with the ability to learn and grow during a two-year assignment, comfortable investigating deviations, and capable of collaborating with engineering and vendor teams, with potential for future conversion based on performance.
Master’s degree could be considered a plus.
Open to non-traditional candidates if lab/instrument experience is applicable.

In this role, the candidate will work cross functionally supporting tech transfer activities for clinical and commercial with client and CMO sites, getting exposure to the FDP manufacturing processes for automated and HMLV (high mix low volume) processes for combination products (device assembly, labeling, and packaging). This includes identifying and exploring technologies in partnership with site PD, NPI lead, Validation Engineering, and Project Management.

Entry-level preferred (fresh grads or 1–2 years’ experience; internships valuable).
Bachelor’s in STEM (Mechanical Engineering, Biomedical Engineering, Biotech, etc.).
Experience in:
- Mechanical design, automation, software, process engineering.
- Root cause analysis (RCA).
- Documentation and report writing (large administrative/documentation component).

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Mechanical Design
Automation Software
Process Engineering

Day to Day Responsibilities:

Support Tech Transfer activities
Lead process gap assessment exercises
Generate PTD (Process Transfer Document)
Manage dashboards by updating KPI status and timelines
Support characterization and PPQ activities at the receiving site
Perform forensic analysis of devices
Conduct root cause analysis using standard methodologies
Leverage automation skillset to access and analyze equipment data
Program within statistical analysis software or data tools such as MATLAB
Update and optimize equipment automation recipes for quality, rapid device assembly
Support design of test fixtures and/or assembly tools for manufacturing
Troubleshoot device and equipment failure

Basic Qualifications:

Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Engineering or biotechnology background
Enthusiasm for new technology (digital and mechanical)
Continuous improvement mindset
Clear communication and presentation skills

Employee Value Proposition:
Good potential for learning & growth, with possible conversion after 2 years.

Red Flags:

Overqualification (too much experience, PhD, too many certifications – risk of attrition).
Non-STEM degrees without relevant lab/engineering exposure.
Frequent job hopping (multiple short stints ?6 months).
Generic/AI-generated resumes lacking context.
Unexplained long employment gaps (less critical for entry-level).

Interview process:
1 Phone Screen, 1 Panel In Person (or virtual)

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Process Development Engineer, upstream biologics (JP14405) - Thousand Oaks, CA

Thu, 28 Aug 2025 16:10:36 GMT

Job Title: Process Development Engineer, upstream biologics (JP14405)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: PD B23 Mfg Spt
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 08/28/2025
Pay Rate: $36 - $41/hour W2
Notes: HYBRID 3/4 days onsite, 1-2 remote (activities permitting) at Thousand Oaks, CA. Standard Business hours with some after-hours support (on call for manufacturing support potentially twice a month for 2-4 hours).

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate will be a Process Development Engineer with a strong foundation in upstream biologics, including suspension cell culture, bioreactor operations, and monoclonal antibody production. The engineer will join the Drug Substance Technology Engineering team, supporting the development and manufacturing of human therapeutic products from clinical stages through commercial production. They will apply process engineering knowledge to support technology transfer and manufacturing in an advanced suite utilizing single-use technology.

The ideal candidate will hold a bachelor’s degree in Engineering, Biology, or a related scientific field with 2 to 5 years of relevant experience, or a master’s degree with new graduates considered. They should be proficient in data and statistical analysis tools such as JMP, possess excellent communication skills, and thrive in cross-functional collaboration. Comfort working in a regulated, fast-paced environment and presenting technical data to diverse teams is essential. Candidates who are remote only, lack upstream experience, have excessive short-term job history, or come from non-scientific or non-engineering backgrounds should be avoided.

JOB RESPONSIBILITIES:
Under guidance of senior staff, the Engineer performs the following:
- Transfer cell culture processes for drug substance manufacturing and performs process improvements from the laboratory into the manufacturing facility
- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
- Offer process validation support for late stage commercial processes
- Provide routine process monitoring and troubleshooting
- Execute data trending and statistical process analysis
- Support technical direction for process related deviations, CAPAs and change controls
- Identify and support process related operational excellence opportunities
- Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

PREFERRED QUALIFICATIONS:
• Master’s Degree in Chemical or Biochemical Engineering
• 1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
• Background in biologics tech transfer into commercial facilities
• Cell culture process knowledge: Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
• Strong capability of analysis, troubleshooting and problem solving
• Ability to develop and follow detailed protocols
• Independently motivated with ability to multi-task and work in teams
• Excellent written and verbal communication skills with technical writing and presentation experience

Top Must Have Skills:

Must have at-scale biologics cell culture experience (manufacturing experience, engineering/equipment experience)
Strong understanding of data analysis tools (JMP preferred)
Excellent communication and troubleshooting (Must be comfortable presenting data & technical information to a group of 20+ people. Presenting at min once per month to quarter)
Knowledge of cell culture processes/ equipment; scale up factors from mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes. GMP experience is a huge plus - someone who has dealt with regulatory inspectors/auditors (FDA, other regulatory agencies from other countries)

Day to Day Responsibilities:
Staff will support all upstream processes (clinical and commercial) executed in the facility, performing process monitoring and responding to issues as appropriate. In addition, staff will perform and/or support tech transfer of early clinical candidate molecules.

Basic Qualifications:
Master’s degree OR Bachelor’s degree and 2 years of Engineering or Operation experience
Associate’s degree and 7 years of Engineering or Operations experience

Red Flags:
Remote work only.
Multiple short-term work experiences
Lack of upstream cell culture/harvest experience
Purification experience only
Non scientific/engineering background/degree
Not sociable
Not good with presenting technical data

Interview process:
Video interview panel with team (1:4/6)
*Available to interview when the candidate is identified*

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454) - New Albany, Ohio

Thu, 28 Aug 2025 12:54:26 GMT

Job Title: Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)
Location: New Albany, Oh 43054
Business Unit: Site Process Development
Employment Type: Contract
Duration: 2+ years with possible extension or conversion to FTE
Rate: $53 - $63/hour (DOE) - W2 with benefits
Posting Date: 8/28/2025.

3 Key Consulting is hiring! We are recruiting a Senior Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

The Senior Validation Engineer position reports into the Sr. Manager of Validation. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations.

Location Options: 100% Site Presence Required. The position is expected to travel for approximately 10%.

Job Description & Responsibilities:
The Senior Validation Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply extensive technical expertise (characterization, validation and troubleshooting) in the validation of combination products. This position also requires the application of advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process optimization, scale up and manufacturing support projects.

Output:
Key responsibilities will include supporting the packaging C&Q activities of the product portfolio to AOH. Additional responsibilities will include the provision of technical operations support for the continuous improvement of device assembly and packaging line capacity and performance, and advisory of technical improvement projects. The Sr. Validation Engineer must ensure effective communication throughout the Ohio commercial site and network with all stakeholders and deliver on technical deliverables.

Relationship:
The Senior Validation Engineering is expected to build on the network expertise across the company commercial and clinical operations for product assembly, label and packaging. The position is expected to leverage this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting/process

The successful candidate will have:

Knowledge of high-speed, highly automated secondary packaging operations
Knowledge of the validation of equipment such as PFS assembly, cartoners, vision systems
Experience in writing protocols
Experience in executing protocols
Capable of executing multiple projects
Communication skills and ability to work with other people
Bring innovative solutions for continuous process improvement
Experience with Kneat
Experience with MiniTab is a plus

Top Must Have Skill Sets:

packaging validation experience
knowledge of packaging equipment
protocol generation and execution

Day to Day Responsibilities:

writing and executing validation protocols.

Value proposition: Unique industry opportunity Networking

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience

Why is the Position Open?
Supplement additional workload on team

Interview Process:
Initial screening with hiring manager
Final interview panel with 3 interviewers

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Combination Device Design, Development & LCM (JP14435) - Thousand Oaks, CA

Wed, 27 Aug 2025 15:49:13 GMT

Job Title: Engineer – Combination Device Design, Development & LCM (JP14435)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: PFS And Lyo Kit Platforms
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 08/27/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Device Engineer will participate in the design, development, and lifecycle management of design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.

Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.

Why is the Position Open?
Conversion backfill.

Top Must Have Skills:

Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
Good Communication and Technical Writing Skills
Statistical Analysis

Day to Day Responsibilities:
The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space. The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems. The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. Fill-Finish experience is a bonus but not mandatory.

Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Adheres to strict documentation practices in a GMP regulated environment
Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
Authors and reviews technical documentation including protocols, reports, and technical assessments
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
Maintains device and combination product design history files for assigned products
Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
Provide general laboratory support including inventory management, sample shipments, and cleanup.
Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications

Preferred Qualifications:

Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
Understanding of Mechanical Design Engineering Concepts
Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
Experience with design controls; including (but not limited to) design verification and transfer
Understanding of risk assessments including hazard and probability analysis
Experience with investigations and quality records
Laboratory and electronic lab notebook experience
Statistical Analysis software (Minitab or JMP)
Experience with Instron force testers using BlueHill Universal
Test method development, GR&R, and text fixture design
Ability to work independently and dynamically across functional teams
Strong technical writing and verbal communication skills including technical presentations (i.e., PowerPoint)
Ability to support complex workstreams under demanding timeline
Understanding of the following standards and regulations:
- Quality System Regulation – 21CFR820;
- Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices – ISO 14971;
- EU Medical Device Regulation – 2017/745

Employee Value Proposition:

Unique industry opportunity
Experience

Red Flags:

No laboratory or analytical experience in GLP setting
Poor communication and technical writing skills
Preference to work remotely or work from home

Interview process:
interview will consist of virtual interview with hiring manager (1-1) and separate panel interview (3-1). Interviews will be scheduled following resume review period.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer – Biotech Automation and Packaging Maintenance (JP14396) - New Albany, OH

Tue, 19 Aug 2025 10:31:05 GMT

Job Title: Associate Engineer – Biotech Automation and Packaging Maintenance (JP14396)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Systems Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 08/19/2025
Pay Rate: $25 - $30/hour W2
Notes: Only qualified candidates need apply. Shift details: Administrative shift 8am - 5pm M-F for approximately first 2-4 months. 6pm - 6am thereafter (graves 15% shift differential)

3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
In this role, you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area in Non-Standard Shifts structure.

Fully onsite New Albany, OH
Shift details: Administrative shift 8am - 5pm M-F for approximately first 2-4 months
6pm - 6am thereafter (graves 15% shift differential)

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Understanding in PLC, HMI, Computer Serialization, Packaging Equipment, Inspection Systems
Experience with automation system hardware and software support, including installation, troubleshooting, machine breakdowns and preventative maintenance.
Strong communication skills: verbal / written, collaboration, influencing, and facilitation.

Day to Day Responsibilities:

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.
Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Support cGMP validation of equipment and processes.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and company policies.
Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for equipment/systems.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program troubleshoot and repair equipment/system failures.
Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
Support Operations using Current Good Manufacturing Practices (cGMP).
Support Operations in non-standard shifts that include weekends and/or holidays as determined by the business.

Basic Qualifications:

Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Employee Value Proposition:

Unique industry opportunity
Career growth
Networking

Interview process:
Virtual meeting
2 interviews
Can start interviewing immediately

Human Factors Engineer, Biopharma Medical Device – Remote (JP14424) - Thousand Oaks, CA

Mon, 18 Aug 2025 15:16:28 GMT

Job Title: Human Factors Engineer, Biopharma Medical Device – Remote (JP14424)
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 08/18/2025
Target start date: 9/15/2025
Pay Rate: $70-80/hr W2 with benefits, or open to market rate DOE.
Note: This can be fully remote but local to Thousand Oaks, Ca is preferred.

3 Key Consulting is hiring a Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: 7–10 years of practical human factors experience in medical devices or combination products. Hands-on implementation experience required.

Nice to Have: Experience with auto-injectors, human factors validation, and engagement with the FDA or global regulatory bodies.

Job Description:
Seeking a results-driven and experienced Human Factors / Usability Engineer (HF/UE) contractor to support the Human Factors Engineering (HFE) team within the broader Combination Product Optimization (CPO) function. This role is critical in ensuring company drug delivery systems and combination products meet the highest standards of usability, safety, and regulatory compliance.

This individual contributor will play a hands-on role across the product lifecycle, from early-stage user research through design input, usability testing, and preparation for FDA and global regulatory submissions. The ideal candidate will thrive in a fast-paced, matrixed environment and bring deep domain expertise in medical devices, combination products, and FDA-regulated usability engineering.

Responsibilities:

Human-Centered Design Integration: Partner cross-functionally with engineering, design, commercial, clinical, regulatory, and quality teams to translate user needs into product design, including user interface (UI) requirements, labeling, packaging, and instructions for use.
Usability Research Execution: Lead or support usability activities such as study design, protocol development, IRB submission, participant recruitment, data collection, moderation, analysis, and reporting for formative and summative studies.
Use Risk Mitigation: Conduct comprehensive task analyses, root cause investigations, and use-related risk analyses to inform product design and identify use-related risks.
Cross-Functional Influence: Serve as a key liaison between HFE and program team functional stakeholders to ensure human capabilities and limitations are reflected in product architecture and usability requirements, and human factors activities are considered at all stages of the product design lifecycle.
Regulatory Readiness: Support the creation of HF documentation for regulatory submissions including HFE protocols/reports, URRAs, and other components of the overall HF File, all in accordance with global standards and FDA guidance.
Stakeholder Engagement: Actively communicate and align with internal and external stakeholders to ensure user-centric solutions are embedded across development programs.

Top Must Have Skills:

Human Factors Engineering
Data Analysis
Technical Writing

Preferred Qualifications:

Advanced degree in Human Factors or Usability Engineering
Deep knowledge of applicable global guidance and standards:
- FDA: 21 CFR Parts 4, 820, 210/211, Human Factors Guidance, relevant device labeling standards
- IEC/ISO: 62366, 14971, 13485
- Other: HE:75, EU MDR Annex 1, additional relevant international device labeling and usability engineering standards
Proven track record supporting both formative and summative usability studies for combination products and injectors (e.g., pens, autoinjectors, on-body delivery systems)
Experience with early concept evaluations, use-risk analyses, and iterative design refinement
Demonstrated ability to influence technical design decisions with a deep understanding of user behavior and cognitive workload
Technical fluency across disciplines—capable of translating human factors insights for engineering, clinical, software, and regulatory audiences
Experience contributing to HF sections of FDA pre-submissions, IND/IDE, NDA, BLA, and global regulatory dossiers
Strong communication, critical thinking, and problem-solving skills in a collaborative environment
Able to manage ambiguity, prioritize competing deadlines, and drive user-centered design in a global organization

Red Flags:

No experience in human factors engineering in the medical device or combination product space.
Less than 5 years of relevant experience
No direct human factors hands on experience

Interview process:
2 rounds of interviews

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Human Factors Engineer, Biopharma Drug Delivery Device IFUs (JP14418) - Thousand Oaks, CA

Fri, 15 Aug 2025 10:14:24 GMT

Job Title: Human Factors Engineer, Biopharma Drug Delivery Device IFUs (JP14418)
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Business Unit: Operations Patient Experience, Engineering Group
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 08/15/2025
Target start date: 9/15/2025
Pay Rate: W2 $60-80/hr. with benefits, or open to market rate DOE.

3 Key Consulting is hiring a Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to document and accurately review and check instruction materials, including Instructions for Use (IFUs) that are used to instruct laypersons in the proper use of combination products/drug delivery devices.
Materials to review will include content copy, layout, line-art illustrations, and other graphical elements for IFUs, carton artwork, and device labeling. Works closely with other designers, HF engineers, and other artwork functions.
In addition to accuracy, role requires instruction checks with quick turnarounds during instruction development to support iterative usability study timelines in a design-test-refine-test model.
Maintains history records of changes to instruction materials to capture rationale for those changes over the development process.
Supports process improvement initiatives, including defining and documenting current procedures within the group and working with cross-functional partners to improve and document labeling across upstream and downstream functions.

Top Must Have Skills:

Minimum 4-6 years of experience reviewing documents including medical device IFUs., including strong proficiency in rapid sketch illustration, digital line-art illustration, and image (photo) editing.
2-4 years’ experience using Adobe Creative Suite software (InDesign and Illustrator) and Microsoft Word and Excel. Knowledge of Microsoft Access and Visio is a plus.
High-level attention to detail and accuracy in reducing errors in work deliverables.
Medical, healthcare, medical devices and/or pharmaceuticals background.
Must be punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects. Strong organization and communication skills.

Day to Day Responsibilities:

Review new and updated IFUs, reference guides, and carton artwork content and graphics (layout and illustrations) for medical device/combination products to ensure accuracy. Some reviews will use digital comparison tools; other reviews will require manual checking.
Maintain change history of instruction materials during their development, including changes from regulatory authorities and Human Factors studies.
Ensure changes to specific projects are communicated to other programs for implementation.
Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate.
Develop instruction design strategies for individual projects that align with department and corporate instruction platforms. Manage individual projects, representing the Instruction Design group, by coordinating with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements and execute on plans.
Support process improvement programs and documentation as it relates to design and development processes.

Employee Value Proposition:

Career growth
Networking
Unique industry experience

Red Flags:

Review experience with text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals, defense user manuals). This role needs applicants with experience reviewing graphics as well as copy.
Only has checking experience; role requires ability to contribute to improving processes involving design and checks.

Interview process:

To be considered, candidates MUST supply an online portfolio
TEAMs/ video conference panel

Process Engineer – Biotech Downstream/Tech-Transfer (JP14390) - Cambridge, MA

Thu, 14 Aug 2025 14:08:35 GMT

Job Title: Process Engineer – Biotech Downstream/Tech-Transfer (JP14390)
Location: Cambridge, MA. 02138 / Hybrid or Remote
Employment Type: Contract
Business Unit: Internal and External PE
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Rate: $36 - $41/ hour W2 with benefits
Posting Date: 08/14/2025
Notes: This position can be Hybrid or Remote. Standard Business hours.
Local to Cambridge MA or Thousand Oaks CA would be nice but not necessary.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal candidate: 3+ years of industry experience, comfortable presenting. Biologics/ drug substance purification experience required (Chromatography, filtration, UFDF unit ops) Knowledge of purification processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a huge plus.

Job Description:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge site. Providing strong process engineering/ technology transfer support of human therapeutic products in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Engineer will apply downstream process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer.

JOB RESPONSIBILITIES:
Under guidance of senior staff, the Engineer will perform the following:

Transfer purification processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities
Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
Assist in troubleshooting clinical and commercial runs
Execute data trending and statistical process analysis
Support technical direction for process-related deviations, CAPAs, and change controls
Identify and support process-related operational excellence opportunities
Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

Top Must Have Skills: Downstream Process, Tech Transfer, Scale-up

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
Predominant Upstream, Analytical or Drug Product experience

Interview process:
1on1 teams and Panel interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Engineer, Biotech Manufacturing/Packaging Lines (JP14376) - New Albanay, Oh

Thu, 07 Aug 2025 15:08:47 GMT

Job Title: Senior Engineer, Biotech Manufacturing/Packaging Lines (JP14376)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Systems Engineering
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 08/07/2025
Pay Rate: $40 - $46/hour W2 with benefits

3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: 4+ YOE, experience supporting a manufacturing line, and GMP or regulated environment experience.
Nice to have: relevant pharma experience, experience starting up a new manufacturing line.

Job Description:
In this role the Senior Engineer (Line Owner/System Owner) must work under general supervision, owns all the technical aspects in a manufacturing line. The processes the SO/LO Engineer shall be familiar with are characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects.

Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

As a technical resource of an area, System owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. At the same time, the System Owner/Line Owner Engineer shall be able to define design requirements to the service providers to fulfill area technical and equipment needs.

Specific responsibilities include but are not limited to:

Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision, will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
Initiate and complete routine technical tasks.
Operations Engineering:
Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.

Design Engineering:

- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
- Work with consultants, architects and engineering firms on development of standard design documents.
- Acquire and critique quotes for equipment modifications or installations.
- Generate rudimentary project cost estimates and schedules.

Preferred Qualifications:

Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
Knowledge of pharmaceutical/biotech processes
Familiarity with validation processes for Packaging areas
Familiarity with serialization process and networking
Familiarity with documentation in a highly regulated environment
Ability to operate specialized equipment, tools and computers as appropriate.
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
Ability to apply engineering science to production.
Able to develop solutions to routine technical problems of limited scope
Comprehensive understanding of protocol requirements.
Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
Excellent communication (verbal/written) and presentation skills
Demonstrated interpersonal skills including; collaboration, influencing, and facilitation
Protocol and script testing Writing
Dealing with and handling change
Packaging Equipment Technical knowledge
Analytical Problem Solving
Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Contex

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Experience in a manufacturing environment, preferably GMP regulated or other highly regulated environment
Experience working hands-on to solve technical problems on manufacturing equipment
Great communication skills

Day to Day Responsibilities:

Act as the equipment technical subject matter expert for an end-to-end pharmaceutical device assembly and packaging line.
This individual is responsible for working with the maintenance and automation teams to resolve complex issues that are escalated beyond the technician level.
This individual also leads improvement projects to increase line OEE.

Basic Qualifications:
Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience.

Employee Value Proposition: Leading Biotech Experience

Red Flags:
Any time at companies shorter than 6mo, although the hiring team understands some contracts are shorter.

Interview process:
Round 1 - 1 on 1 interview with hiring manager
Round 2 - Panel interview with 2-3 engineers/managers

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Automation Senior Software Engineer, Biotech, DSC, SCADA HMI, PLC - (JP14368) - Thousand Oaks, CA

Mon, 04 Aug 2025 10:11:15 GMT

Job Title: Automation Senior Software Engineer, Biotech, DSC, SCADA HMI, PLC - (JP14368)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Advanced Technology and Automation
Duration: 3 years with possible conversion to permanent
Posting Date: 08/04/2025
Pay Rate: $60 - $80/hour W2 DOE with benefits
Note: Fully onsite thousand oaks 8am-5pm M-F, OT possible

3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Responsibilities:

Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment.
Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes.
Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems.
Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

5+ years of experience working on Rockwell Automation and Allen-Bradley PLCs (Factory Talk & ControlLogix)
Experience with Process Design, Commissioning and change control methodology.
Direct experience with regulated environments including detailed understanding of cGMPs.

Day to Day Responsibilities:
Able to support manufacturing operations through effective troubleshooting and ensuring automated equipment uptime and reliability. Update and read P&IDs, instrumentation and electrical design packages including SDS, HDS, URS, IQ, OQ, VP and VSR among other engineering and validation documentation. Development of detailed specification, engineering documents, SOP and operating standards.

Preferred Qualifications:

B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.
Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.
5 or more years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
Knowledge of S88 and S95 techniques. - Batch processing a desired advantage.
Strong leadership, technical writing, and communication/presentation skills are required.
Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.
Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
Preferred Experience using the following systems:
a. Lyophilizer System, Filling systems for Syringe and Vials and Building Management System
b. Testing and Inspection machines for devices
c. Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System)
d. Cleaning Systems (Autoclaves, Depyro oven , COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer)
10) Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Employee Value Proposition:
Great company culture, beautiful campus, and chance to work with innovative technology.

Red Flags:
Job hopping - longevity concern
Job is on-site. No remote work allowed.

Interview process:
Two-step interview process - Phone screen followed by In-Person interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Biotech Tech transfer (JP14348) - Thousand Oaks, CA

Thu, 31 Jul 2025 13:52:26 GMT

Job Title: Engineer, Biotech Tech transfer (JP14348)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Process Engineering
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 07/31/25
Pay Rate: $36 - $41/hour W2 with benefits

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate for this role should have a bachelor’s degree in any engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. They should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills.

This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop overtime.

As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at company site in Thousand Oaks and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of company products.

The candidate will assist in establishing the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicating results to cross functional groups.

Responsibilities include, but are not limited to, the following:

Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
Support development and maintenance of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
Development of digital tools and models by leveraging data analytics and programming

Skills:

Support at scale characterization and/or process validation runs as person in plant
Preferred Qualifications:
B.S. in engineering discipline with 1‒3 years’ experience or M.S. in engineering discipline with 0‒2 years’ experience
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude

Scope includes a wide range of devices such as Cleaning Systems (Autoclave, Glassware Washers, Dryers, CIP/COP), Single Use Systems (TFF, VI/VF, Chrom). SS Systems (TFF, VI/VF, Chrom, Columns, Tanks, Pumps), and miscellaneous equipment. The qualified candidate will work with the manufacturing and engineering team to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Self-motivated
Willing to learn and explore
Self-sufficient

Red Flags:

Limited prior working experience
Frequent role changes in short timespans
Unable to communicate working experience
Over 6+ years of experience

Interview process:
1 Digital Panel (Hiring manager + team member)
for further progression, 1 Digital Discussion confirmation with Management

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Project Manager, Chemistry Manufacturing Control (CMC)/SmartSheets/Sharepoint- (JP14338) - Newbury Park, CA

Thu, 31 Jul 2025 12:04:00 GMT

Job Title: Project Manager, Chemistry Manufacturing Control (CMC)/SmartSheets/Sharepoint- (JP14338)
Location: Thousand Oaks, CA. 91320 - HYBRID
Employment Type: Contract
Business Unit: Final Product Technologies/Development Product Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 07/31/25
Pay Rate: $67 - $77/hour W2 with benefits
Notes: Hybrid (85% remote) local candidates preferred. 8 am- 5pm however, projects are global and selected candidate must align to assigned projects. Only qualified candidates need apply.

3 Key Consulting is hiring a Project Manager, Chemistry Manufacturing Control (CMC)/SmartSheets/Sharepoint for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Manages one or more high-level, complex TECHNICAL combination product projects within the constraints of scope, quality, time, and cost, to deliver specified requirements. Projects may be strategic in nature.
Responsibilities may include resource allocation and all phases of development life cycle (i.e. feasibility study, requirements, analysis, business plan, design, testing, and implementation planning, among other).
Regularly interacts with management. Coordinates and directs the activities of project team members.
May be responsible for cross-functional teams.
Ensures all project requirements and/or objectives are documented. May obtain and manage external resources required for project completion.

Why is the Position Open?
Backfill.

Top Must Have Skills:

***Extensive smartsheet experience is required***
*** No IT or capital project candidates***
Extensive working knowledge on Chemistry Manufacturing Control
Combination products background and Medical devices savvy and deep understanding of design control process of medical devices.
Smartsheet work knowledgeable on the creation, development and maintenance of fully integrated timelines, reports and dashboards. Candidates without Smartsheet extensive knowledge will not be considered.

Day to Day Responsibilities:
Responsible for overall creation, coordination, status reporting and stability of technical, projects oriented work efforts for medical devices and combination products.
Establishes and implements project management processes and methodologies for the Final Combination Product Platform community to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
Responsible for assembling highly complex project plans and teamwork assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review; and escalating functional, quality, timeline issues appropriately.
Responsible for tracking key project milestones and adjusting project plans and/or resources to meet the needs of customers.
Coordinates communication with all areas of the enterprise that impacts the scope, budget, risks and resources of the work effort being managed.
Assists Program Manager(s) in partnering with senior management of the business community to identify and prioritize opportunities for utilizing Final Combination Product platform activities to achieve the goals of the enterprise.
Must possess extensive knowledge and expertise in the use of project management methodologies and tools (Smartsheet is a must for this position, MS Project, One Pager), resource management practices and change management techniques.
Manages one or more cross-functional projects of medium to high complexity.

Basic Qualifications:

Doctorate degree or Master’s degree and 2 years of experience or Bachelor’s degree and 4 years of experience or Associate’s degree and 8 years of experience or High school diploma / GED and 10 years of experience
Expertise in running medium to large scale Combination Products (drug and device) project
Excellent understanding of project management processes and procedures
Experience with project management and analyst methodologies and best practices
Strong analytical skills
Business process development best practices, change management
Strong Smartsheet, MS Project, MS Word, Visio, MS PowerPoint, SharePoint, One Pager skills.
Understanding of systems for sharing and collaboration
Excellent communication skills to work with cross-program resources.

Employee Value Proposition:
This project is heavily technical. Candidates must be a self starter and have ability to understand combination product. You will work with all cross functional teams from quality to human factors.

Red Flags:

Required: Extensive Smartsheet and SharePoint working knowledge.
Very important: Will not consider IT, Supply Chain or Construction Project Managers. This is a totally different area and out of their expertise.
Local candidate preferable the person may be required to be onsite at some point. Remote workers may be considered if really strong candidate.

Interview process:
***Virtual interviews***
Initial screening with hiring manager. Will include working assessment on Smartsheet knowledge and design control of medical devices.
Panel interview with different customer the team is currently supporting.

Associate Engineer, Equipment Maintenance - BioPharma (JP14336) - New Albany, OH

Mon, 28 Jul 2025 11:00:51 GMT

Job Title: Associate Engineer, Equipment Maintenance - BioPharma (JP14336)
Location: New Albany, OH. 43054
Business Unit: Manufacturing Systems Engineering
Employment Type: Contract
Duration: 12+ months with likely extensions and/or conversion to a permanent position.
Rate: $28 - $32/hour W2 or Market Rate DOE
Posting Date: 7/28/2025.
Target Start Date: 9/1/2025.
Notes: Day shift - 6:30am - 3pm (Shift times may vary)

3 Key Consulting is hiring! We are recruiting an Associate Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

Responsibilities:

Take part in the coordination of tech support on engineering, regulatory, compliance, quality, microbial/environmental, technical cleaning, validation, and mechanical, electrical and process automation issues.
Complete maintenance activities or operate and monitor plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Company policies.
Investigate equipment issues or problems through the mentorship of experienced staff.
Assist with maintaining an up-to-date working spare parts inventory system for the equipment/systems.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
Support Operations in non-standard shifts that includes weekends and/or holidays as determined by business.

Top Must Have Skill Sets:

2+ YOE maintaining manufacturing equipment
Experience working in a cGMP environment
Excellent communication and documentation skills.

Day to Day Responsibilities:
Support the maintenance, operation, and repair of all manufacturing equipment within the company facility

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
High school/GED + 2 years Maintenance experience Or Associate’s Degree + 6 months Maintenance experience

Preferred Qualifications:

Educational background in Mechanical Engineering, Mechatronics, or related technical degree
Experience repairing mechanical equipment in a manufacturing environment (experience with packaging equipment preferred)
Strong mechanical proficiency and trouble shooting skills
Understanding in PLC, Computer Serialization, Packaging Equipment, Vision Inspection Systems
Excellent organizational, project management, problem solving and technical writing capability
Strong communication: verbal / written, collaboration, influencing and facilitation
MS Office: Word, Excel, Power Point

Employee Value Proposition:
Career growth
Networking
Unique industry opportunity

Red Flags:
Job Hopping - less than 6 months on assignments

Why is the Position Open?
Supplement additional workload on team

Interview Process:
Video conference

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Manufacturing Systems (Automation) Senior Engineer - Electrical (JP14330) - New Albany, OH

Tue, 22 Jul 2025 09:22:29 GMT

Job Title: Manufacturing Systems (Automation) Senior Engineer - Electrical (JP14330) - (JP14330)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Systems Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 07/22/25
Pay Rate: $56 - $62/hour W2
Notes: Only qualified candidates need apply. This is NOT a validation engineering role. 8am-5pm, M-F

3 Key Consulting is hiring a Manufacturing Systems (Automation) Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Engineer position reports to the Manager of Engineering under the Engineering & Maintenance team at our client’s New Albany, OH. facility. This position is at our client’s new advanced product assembly and packaging plant. This role will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, processes, and/or capital projects. In this role, the Mfg. Systems (Automation) Engineer will:

System Design and Development:
- Design and develop automation systems and control strategies for packaging machinery and processes.
- Implement and configure Programmable Logic Controllers (PLCs), Human-Machine Interfaces (HMIs), and other automation equipment.
- Create and maintain detailed documentation, including system specifications, design documents, and operational procedures.
Integration and Optimization:
- Integrate new automation technologies and equipment into existing packaging systems.
- Optimize control processes to enhance efficiency, reduce waste, and improve product quality.
- Conduct feasibility studies and cost-benefit analyses for automation projects.
Troubleshooting and Support:
- Diagnose and resolve issues with automation systems and control equipment.
- Provide technical support and troubleshooting for production and maintenance teams.
- Perform system upgrades and maintenance to ensure optimal performance and reliability.
Compliance and Quality Assurance:
- Ensure that all automation systems comply with FDA regulations, GMP standards, and industry best practices.
- Collaborate with Quality Assurance and regulatory teams to address any compliance or quality issues related to automation.
Project Management:
- Lead and manage automation projects, including planning, execution, and monitoring.
- Coordinate with cross-functional teams to ensure timely and successful project completion.
- Prepare and present project reports, performance metrics, and technical documentation.
Training and Development:
- Train and support staff on the use and maintenance of automation systems.
- Develop training materials and conduct workshops to enhance team competency in automation technologies.

The position is a key role in the Engineering and Maintenance department and the candidate must manage and apply extensive technical expertise in the coordination of multiple, sophisticated, non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration of systems, facilities and processes. This position will also be required to apply advanced and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.

Why is the Position Open?
Planned Project

Top Must Have Skills:

PLC/HMI Troubleshooting (Rockwell, B&R, Siemens)
Industrial Packaging experience
Electrical Design

Day to Day Responsibilities:

Key responsibilities will include working with the engineering and maintenance team to support the commercial production packaging lines.
Additional responsibilities will include providing technical operations support for continuously improving the packaging lines' capacity and performance and advising on technical improvement projects.
The Engineer must ensure effective communication throughout the client’s commercial site network with all stakeholders and deliver on technical improvements.

Basic Qualifications:
Master’s degree
Or
Bachelor’s degree and 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
Or
Associate’s degree and 6 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
Or
High school diploma/GED and 8 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries

Preferred Qualifications:

Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
Knowledge in Data Integrity and Security
Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies
Exposure to Machine Vision, Serialization, Robotics, Siemens, and Rockwell software platform
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment
Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
Excellent communication (verbal/written) and presentation skills
Demonstrated interpersonal skills, including: collaboration, influencing, and facilitation
Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context

Employee Value Proposition:

Networking
Career growth
Unique industry opportunity

Red Flags:
No validation candidates for this role. This is automation.

Interview process:
Video Skype Panel Interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Combination Product Medical Devices - (JP14307) - Thousand Oaks, CA., California

Tue, 15 Jul 2025 16:11:47 GMT

Job Title: Engineer, Combination Devices Medical Device (JP14307)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Final Product Technologies/Development Product Engineering
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 07/15/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. ***Recent college graduates welcome***

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This position reports into the Combination Product Operations Development and Lifecyle Management group in Thousand Oaks, CA. The candidate will support senior staff in device development, characterization, and verification of combination products. This position requires the application of engineering principles to perform the job functions and the ability to coordinate and communicate effectively across different functions to successfully complete projects.

In this role, the candidate will be required to:

Plan and author technical documentation, including test plans/protocols/reports and a variety of engineering assessments.
Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes).
Analyze and report data, along with any recommendations, to a variety of stakeholders.
Provide technical input for mechanical problems to programs as needed.
Plan and execute tolerance and robustness analysis of complex mechanical designs.
Use project planning to monitor and track project deliverables to ensure accurate completion.
Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle.
As part of the team working on device platforms, ensure alignment of documentation to support variants and combination products.

Why is the Position Open?
Additional hands for project

Top Must Have Skills:

Strong written and oral communication skills
Able to execute lab test, which includes safe and proper operation of lab equipment
Experience in drug/device combination product design, and development

Day to Day Responsibilities:

Planning and executing testing, Coordinate material hand-offs, Authoring, reviewing and approving documents, attending and participating in the team meetings (as needed)

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
B.S. in Engineering or Scientific Discipline
Effective Communicator (Oral/Written)
Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

Preferred Qualifications:

Broad set of knowledge and expertise in contributing to complex, multi-disciplinary and cross-functional product development efforts
Experience in drug/device combination product design, and development
Background in development, commercialization, and lifecycle management of medical devices
Physical test method development, qualification, and validation
Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, manual and automated autoinjector testing, CT scanner etc.)
Experience conceptualizing, designing, and building test fixtures
Technical understanding of drawings including tolerance stacks and robustness analysis
Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
Familiarity with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601)
Knowledge of dFMEA/pFMEA
Capable of working on multiple projects in a deadline driven environment
Strong oral and written communication skills, decision making, presentation, and organization skills
Ability to collaborate with other disclines within the technical team such as, systems engineering, design engineering, human factors, MSAT, packaging engineering and other functions e.g., drug product, drug substance and product quality.
Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach
Track record of building or participating as a member of successful teams
Working knowledge of MS Office tools, Solidworks, Minitab or JMP and Smartsheet

Employee Value Proposition:

Gaining combination product development experience and a better sense of device performance.
Will gain auto injector experience

Interview process:
Phone interview(s).

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Principal, Medical Device Development & Packaging C&Q - (JP14217) - New Albany, OH

Mon, 07 Jul 2025 17:24:00 GMT

Job Title: Engineer Principal, Medical Device Development & Packaging C&Q - (JP14217)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process development
Duration: 1+ years (with possible extension)
Posting Date: 07/07/25
Pay Rate: $51 - $56/hour W2
Notes: Only qualified candidates need apply. Onsite AOH - Monday - Friday - Standard 8-5. Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month.

3 Key Consulting is hiring an Engineer Principal, Medical Device Development & Packaging C&Q for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate will have 10 years of experience. (See below for details). This position will be onsite in New Albany, OH., Monday - Friday - Standard 8-5. Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month.

The qualified candidate will lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as: needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
The candidate will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
The role of the Principle Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Why is the Position Open?
Planned Project

Top Must Have Skills:

Material & test specs generation, protocol & report writing.
Process & test development, prototyping, design verification.
DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Nice to have: packaging process experience

Day to Day Responsibilities:
Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Responsibilities include:

Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
Create and assess product requirements to determine technical coverage and proper integration different subsystems.
Create and execute to project plans and schedules
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Provide deep technical assistance for junior engineers.

BS in Engineering and previous experience in a medical device industry
10 years current experience with engineering processes and procedures.
Led projects from development through the 510k and PMA approval process.
Strong background in engineering and commercialization of electro-mechanical medical devices.
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in drug/device combination product design and development
Familiar with the following standards:
- Quality System Regulation 21CFR820
- Risk Management ISO 14971
- EU Medical Device requirements Council Directive 93/42/EEC
- Medical Electrical Equipment EN 60601
Small scale device assembly experience.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Strong problem solving, risk assessment, and risk management skills.
Must be capable of working on multiple projects in a deadline driven environment.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!

Sr. Automation Engineer – Drug Product Fill/Finish (Rockwell, PLC/DCS) JP14202 - Thousand Oaks, CA

Thu, 12 Jun 2025 18:08:06 GMT

Job Title: Sr. Automation Engineer – Drug Product Fill/Finish (Rockwell, PLC/DCS) JP14202
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Advanced Technology & Automation
Duration: 3 years (with possible conversion to permanent)
Posting Date: 06/12/25
Pay Rate: $75 - $83/hour W2
Notes: Only qualified candidates need apply. Fully on site in Thousand Oaks, CA. 91320. 8am-5pm M-F, OT possible

3 Key Consulting is hiring a Sr Engineer – Automation Software (PLC, DCS, HMI, SCADA) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Sr. Engineer – Automation Software will support manufacturing operations through effective troubleshooting and ensuring automated equipment uptime and reliability. Update and read piping and instrumentation Diagrams (P&IDs), instrumentation and electrical design packages including software design specs (SDS), hardware design specs (HDS), user requirement specs (URS), qualification documents (IQ, OQ, VP, VSR) among other engineering and validation documentation. Development of detailed specifications, engineering documents, SOPs and operating standards.

Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment.
Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes.
Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems.
Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

Why is the Position Open?
Additional work needed

Top Must Have Skills:

5+ years of experience working on Rockwell Automation and Allen-Bradley PLCs (Factory Talk & ControlLogix).
Experience with Process Design, Commissioning and change control methodology.
Direct experience with regulated environments including detailed understanding of cGMPs.

Basic Qualifications:
Doctorate degree OR - Master’s degree & 2 years of directly related experience OR - Bachelor’s degree & 4 years of directly related experience OR - Associate’s degree & 8 years of directly related experience OR – High school diploma / GED & 10 years of directly related experience

Preferred Qualifications:

B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.
Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.
5 or more years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
Knowledge of S88 and S95 techniques. - Batch processing a desired advantage.
Strong leadership, technical writing, and communication/presentation skills are required.
Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.
Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
Preferred Experience using the following systems:
- Lyophilizer System, Filling systems for Syringe and Vials and Building Management System
- Testing and Inspection machines for devices
- Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System)
- Cleaning Systems (Autoclaves, Depyro oven , COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer)
Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Red Flags:
Job hopping - longevity concern
Job is on-site. No remote work allowed.

Interview process:
Phone screen followed by In-Person interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Process Engineer, Biotech Process Equipment Owner - (JP14141) - Holly Springs, NC

Wed, 04 Jun 2025 18:16:52 GMT

Job Title: Process Engineer, Biotech Process Equipment Owner - (JP14141)
Location: Holly Spring, NC. 43054
Employment Type: Contract
Business Unit: ANC Engineering & Automation
Duration: 3 years with likely extensions and/or conversion to permanent
Number of openings: 3
Posting Date: 06/04/2025
Pay Rate: $32 - $38/hour
Notes: Standard business hours (~8 to 5) with flexibility for: Evening or weekend work, Occasional holiday support, Up to ~50 hours/week, assuming occasional OT

3 Key Consulting is hiring Process Engineers for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal candidate is a commercially experienced Process Engineer with a BS in Chemical, Mechanical, or Biomedical Engineering, who has supported large-scale drug substance operations in biotech or pharma. They are hands-on with equipment ownership (not maintenance) and are highly adaptable, collaborative, and proactive. The ideal candidate embraces ambiguity, is passionate about solving complex operational problems, and thrives in a startup-like GMP environment where they can wear multiple hats, support dynamic business needs, and help drive continuous improvement initiatives. Recruiters expected to pre-screen thoroughly and look for tangible examples of initiative and project ownership. Ideal resumes will show practical accomplishments and clearly demonstrate team-based, cross-functional efforts

Not a maintenance role:
They design/own the equipment and support proper maintenance planning, not execution.
This opportunity is based at a brand-new, advanced biologics manufacturing plant. The site features a cutting-edge FleX Batch facility that combines the latest in disposable technologies with traditional stainless-steel systems, enabling maximum operational flexibility. The facility integrates best-in-class manufacturing processes and industry 4.0 capabilities, along with sustainability initiatives designed to reduce carbon emissions and waste.

Top Must Have Skills:

Experience working in commercial biotech manufacturing industry.
Strong drive and proven results in solving complex and ambiguous problems.
Demonstrated ability to work well in highly collaborative environments.

Responsibilities:
In this role, the Engineer will report to the Senior Manager of the Process Engineering group and will provide daily engineering support to the site. Responsibilities include:

Serve as system owner for process equipment and systems supporting manufacturing operations.
Provide engineering support for design, construction, startup, commissioning, and qualification of new or modified systems.
Identify and/or lead implementation of small-to-medium scale equipment or facility improvements, including development of business cases.
Develop maintenance programs, ensure spare part availability, and coordinate execution to maintain system reliability.
Ensure systems operate safely and in compliance with EHS standards and regulations.
Support commissioning and qualification activities in alignment with GMP requirements and regulatory inspections.
Apply engineering principles in daily operations, maintenance, and troubleshooting of plant systems.
Monitor system performance and implement risk-reduction strategies.
Lead or support troubleshooting efforts to minimize production downtime, including root cause analysis and CAPA implementation.
Support new product and technology introductions via engineering assessments, equipment modifications, and pilot runs.
Advance use of predictive maintenance and condition-based monitoring using data analytics where applicable.
Lead or contribute to deviation investigations and other quality-related processes.
Analyze and present findings related to operational issues and engineering projects.
Provide technical support to commercial and clinical manufacturing, specifically in process control and equipment.
Collaborate with cross-functional groups such as manufacturing, process development, utilities, maintenance, quality, and validation to drive operational improvements.
Maintain regular communication with leadership and team members, escalating issues with proposed solutions.
Participate in a small engineering team on a project or ongoing support basis.
Provide rotational on-call support for utility systems, including nights, weekends, and holidays as needed.
Participate in the design and selection of systems, instrumentation, and components.
Evaluate supplier capabilities and assess new technologies to improve cost, throughput, or technical capabilities.

Preferred Qualifications:

Bachelor’s degree in Chemical or Mechanical Engineering.
3+ years of relevant work experience, including 2+ years in a biopharmaceutical manufacturing environment.
Hands-on experience with GMP production equipment such as bioreactors, centrifuges, filtration systems, and purification technologies.
Proficiency with equipment and facility control systems, including troubleshooting and logic understanding.
Experience in regulated environments (e.g., cGMP, OSHA, EPA) and knowledge of quality systems (e.g., change control, non-conformances, CAPA, validation).
Strong communication, technical writing, and presentation skills; ability to work independently.
Proven team collaboration and facilitation skills.
Analytical thinking with the ability to interpret complex problems using multiple data sources.
Ability to support capital projects and implement process improvements.
Understanding of capital project execution from procurement through validation in GMP environments.
Commitment to safety and compliance in all engineering activities.
Self-starter with excellent organization, time management, and multitasking skills.
Willingness to work flexible hours in support of 24/7 manufacturing operations.

Why is the Position Open?
Additional team member

Red Flags:

Gaps in employment without clear justification
Not a maintenance role: They design/own the equipment and support proper maintenance planning, not execution.
Not a research role. Candidates with advanced degrees seeking research roles should not be submitted.
Lack of biotech experience.
Lack of desired degree (Chemical, Mechanical, or Biomedical Engineering).
Rigid personalities or candidates uncomfortable with ambiguity or startup-like agility

Interview process:
Manager Phone Screening followed by interview panels and post panels follow-up meeting with hiring manager.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Packaging C&Q Support - (JP14167) - New Albany, OH

Mon, 02 Jun 2025 15:31:10 GMT

Job Title: Engineer, Packaging C&Q Support - (JP14167)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process Development Group
Duration: 2+ years (with likely extensions and/or conversion to permanent)
Posting Date: 06/02/2025
Pay Rate: $32 - $37/hour
Notes: Only qualified candidates need apply. 10 PM to 6:30 AM Shift. Some potential travel 5% of the time.

3 Key Consulting is hiring an Engineer Senior, Packaging C&Q Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation.

Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms.
Assist with project definition by performing engineering studies and assessment for Packaging Systems installations.
Perform field evaluations of existing systems and provide engineering design recommendations.
Candidates need to be flexible within working shifts.
- This position should not exceed 48 hours a week but, overtime and flexibility will be needed as per Project Executions requirements. This position is for the third shift (10:00 PM to 6:00AM) Mon-Friday part of the time with weekend shifts during peak project implementation.

Why is the Position Open?
Backfill.

Top Must Have Skills:

Bachelor degree minimum
GMP Experience
Flexibility and Team Player

Day to Day Responsibilities:

Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation.
Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms.

Bachelor’s degree minimum
Experience on a GMP environment
Bio-Pharma Knowledge
Team Player

Employee Value Proposition:
Working for a dynamic team.

Red Flags:
No flexibility for the working hours required.

Interview process:
2 steps panels interviews.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, GMP Packaging Lab, Unit Testing & Documentation (JP14146) - Thousand Oaks, CA

Mon, 02 Jun 2025 14:21:24 GMT

Job Title: Associate Engineer, GMP Packaging Lab, Unit Testing & Documentation (JP14146)
Location: Thousand Oaks, Ca
Business Unit: DP&DD Pre-Comm. Packaging Development
Employment Type: Contract
Duration: 12 months with likely extensions and/or conversion to a permanent position.
Rate: $30 - $35/hour W2
Posting Date: 6/2/2025.

3 Key Consulting is hiring! We are recruiting an Associate Test Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal candidate: Flexible with overtime during the week when necessary. Rarely will they need to work over 12 hours in a day. Ideal candidates will have a bachelor’s degree in engineering (mechanical, biomedical, or bioengineering) or bioscience, or equivalent relevant experience in biomanufacturing. Hands-on lab experience, academic or professional, is strongly preferred, along with familiarity using testing equipment such as Instron force testers, CCI testers, or CT scanners. The role involves executing laboratory tests, supporting investigations, drafting protocols and reports, organizing test data, and contributing to process improvements. Strong technical writing skills, attention to detail, and an analytical mindset are essential. Candidates should be adaptable, collaborative, and eager to learn in a fast-paced, hands-on environment.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for primary containers (vials, stoppers, and syringes) and medical devices.
Responsibilities include:
- Employing basic science and engineering skills and practices to gather user requirements and translate them into technical documentation for execution
- Assisting with project definition by performing engineering studies and assessments

Skills:

Previous lab experience
Strong oral and verbal communication and presentation skills
Experience in analysis of data generated from a variety of analytical techniques is preferred

Top Must Have Skill Sets:

Technical writing skills
Strong ability to analyze data generated from a variety of analytical techniques and systems is preferred
Previous lab experience in Engineering or Biochemistry labs is helpful but not required

Day to Day Responsibilities:
Assist engineers with the following:

Designing studies and drafting protocols
Compiling historical data from different analytical systems\
Analyzing data and presenting results
Writing summary reports
Executing protocols, including lab testing (using vacuum decay leak tester, Instron force testers, balances, microscopes, pressure chambers, analytical measurement equipment such as calipers, optical comparators, bore gauges, automated stoppering units, pipettes, and decrimpers).

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Value proposition:
Great company culture & very supportive tea

Red Flags:
- Candidate has inflexible schedule
- Candidate cannot work possible overtime
- Candidate cannot work onsite at Thousand Oaks, CA
- Bachelor’s degree not in Bioscience or Engineering

Why is the Position Open?
Supplement additional workload on team

Interview Process:
Phone interview plus team/panel style interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Biotech Downstream Process Equipment Maintenance - (JP14100) - Thousand Oaks, CA

Wed, 28 May 2025 12:01:06 GMT

Job Title: Engineer, Biotech Downstream Process Equipment Maintenance - (JP14100)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: F&E Drug Substance Supply.
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 05/28/25
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate:

B.S. 2-3+ YOE troubleshooting equipment.
Lead the troubleshooting and vendor support for a wide variety of process equipment that supports manufacturing.
Nice to have: PNID experience

GMP / FDA Background
Biotech / Pharma Equipment Troubleshooting Background
Cleaning Systems, Single Use Systems Experience

Day to Day Responsibilities:

Troubleshooting process equipment, coordinating PMs / Calibrations, etc.
Work cross-functionally with individuals and project teams in Engineering, Instrumentation, and Manufacturing.
Determine technical coverage and proper integration of different subsystems.
Provide deep technical assistance for other support staff and operators using equipment.

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
BS in Engineering, Biotech, Chemistry, or Equivalent and previous experience in a biotech/pharmaceutical industry with focus on usage and/or process equipment of specified equipment
2 years current experience with processes equipment troubleshooting and GMP procedures.
Strong background in troubleshooting, root cause analysis, and vendor coordination.
Must be capable of working on multiple projects in a deadline driven environment.

Red Flags:

No GMP / FDA experience
Not looking for operators
Candidates must have hands on troubleshooting experience

Automation Engineer Senior, Software, Biotech DeltaV, SCADA, PLC - (JP5947) - Thousand Oaks, CA

Tue, 27 May 2025 13:06:08 GMT

Job Title: Automation Engineer Senior, Software, Biotech DeltaV, SCADA, PLC - (JP5947)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Advanced Technology and Automation
Duration: 3 years (with likely extensions and/or conversion to permanent)
Posting Date: 05/27/24
Pay Rate: $60 - $80/hour W2 DOE with benefits

3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Responsibilities:

Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process equipment.
Ownership and administration of process control automation in a GMP regulated manufacturing setting. Engage in process change control requests per established SOP and processes.
Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to mechanical, electrical, instrumentation and control systems.
Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

5+ years of experience working on Rockwell Automation and Allen-Bradley PLCs (Factory Talk & ControlLogix)
Experience with Process Design, Commissioning and change control methodology.
Direct experience with regulated environments including detailed understanding of cGMPs.

B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering.
Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.
5 or more years combined experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
Knowledge of S88 and S95 techniques. - Batch processing a desired advantage.
Strong leadership, technical writing, and communication/presentation skills are required.
Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.
Experience in developing automation strategies for New Product Introduction and New Technology Deployment.
Preferred Experience using the following systems:
a. Lyophilizer System, Filling systems for Syringe and Vials and Building Management System
b. Testing and Inspection machines for devices
c. Clean Utilities (WFI Still A\B, Clean Steam Generator, Chemical Dist. System, WFI Storage & Distribution and Purification System)
d. Cleaning Systems (Autoclaves, Depyro oven , COPs and Glass Washers, Pressure Vessel Washer, Vial Washer and Ultrasonic Washer)
10) Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Sterilization Senior Engineer, Biotech Manufacturing (JP14138) - Cambridge, MA

Fri, 23 May 2025 17:37:20 GMT

Job Title: Sterilization Senior Engineer, Biotech Manufacturing (JP14138)
Location: Cambridge, MA. 02138
Business Unit: Manufacturing Science and Technology
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $50/hour W2 with benefits
Posting Date: 05/23/2025.

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Gas Sterilization for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for client’s portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.

Top Must Have Skill Sets:

Sterilization experience
Qualification/ quality experience
Commercial process lifecycle management

Preferred Qualifications:

3+ years in ethylene oxide or other gas sterilization processes
3+ years industry experience in sterility assurance of combination products
3+ years in ethylene oxide, moist heat, and/ or vaporized hydrogen peroxide sterilization
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Strong problem-solving skills
Capability to advance multiple projects in a fast paced environment
Strong oral and written communication skills, decision making, presentation, and organization skills

Ideally looking for someone locally but open to someone who will relocate with the proper and strong sterilization experience.

Day to Day Responsibilities:

Support/ lead process development and commercialization of gas sterilization processes of combination products
Coordinate/ lead manufacturing site requirements to support sterilization requirements
Support the design control process and qualification of primary components
Support/ lead tech transfer projects for combination products
Support/ lead the development and operational improvements with key primary component suppliers
Support development of characterization methods for mechanical and physical properties of primary components
Support on-going deviation/ CAPA and change control
Support/ lead client’s supplier/ raw materials sterility assurance assessments
Collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
Drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences

Employee Value Proposition:
Career growth
Opportunity
Experience

Interview Process:
Phone and In Person

Why is the Position Open?
Supplement additional workload on team

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Biotech Product Complaint (JP14126) - Thousand Oaks, CA

Wed, 21 May 2025 09:15:04 GMT

Job Title: Associate Engineer, Biotech Product Complaint (JP14126)
Location: Thousand Oaks, CA. 91320 - Hybrid
Business Unit: Complaints Trending
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $32 - $35/hour W2
Posting Date: 04/21/2025
Notes: Must be local to be onsite 80% of the time.

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Principal Engineer in the Complaints Trending and Investigation group. In support of the company’s mission to serve patients, the Complaints Trending and Investigation group is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize patient experience.

The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis as well as supporting/leading root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the CT&I lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Responsibilities:

Perform device assessments of complaints and document results in a report.
Perform root cause analysis investigations for mechanical and/or electromechanical products
Complete evaluation and deliver assessment report on time per Company’s requirements.
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
Support characterization testing and data gathering for investigations

Preferred Qualifications

Master’s or bachelor’s in engineering, Science or Biomedical 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience in lab environment
Demonstrated competency in root cause analysis methodology
Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented

Top Must Have Skill Sets:

Strong technical, analytical and problem-solving skills
Strong interpersonal, communication, and teamwork skills
Skills and experience in lab environment

Day to Day Responsibilities:

Perform device assessments of complaints using equipment such as CT scanner, microscope and other measurement/imaging equipment in a laboratory environment and document results in a report.
Onsite 80%, must be available to go onsite when needed.

Why is the Position Open?
Supplement additional workload on team

Red Flags:
Short timer employment
No technical or engineering experience/education

Interview Process:
1st phone interview with hiring manager
2nd virtual interview with hiring manager and team.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Mechanical Engineer/Data Scientist, Medical Device & Mathematical Modeling (JP14031) - Thousand Oaks, CA

Wed, 14 May 2025 21:57:28 GMT

Job Title: Mechanical Engineer/Data Scientist, Medical Device & Mathematical Modeling (JP14031)
Location: Thousand Oaks, CA. 91320 - Hybrid
Business Unit: Combination Drug Device Product Predictive Modeling & Enabled Insights
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $50 - $55/hr on W2 with benefit
Posting Date: 5/14/2025.
Notes: Hybrid at Thousand Oaks. Expectation is 3 days onsite per week.

3 Key Consulting is hiring! We are recruiting an Engineer (Mechanical, Chemical, Biomedical) with Data Science focus for a consulting engagement with our direct client, a leading global biotechnology company.

The ideal candidate is a Data Scientist with a strong engineering background, preferably in Mechanical, Biomedical, or Chemical Engineering, with proven experience in simulation, modeling, and data analysis within a GMP-regulated environment. They are proficient in Python, MATLAB, and Minitab, and possess a deep understanding of engineering principles applied to physical systems. The candidate holds either a PhD with no required industry experience, a Master’s degree with at least 2 years of experience, or a Bachelor’s degree with a minimum of 4 years of experience. They are highly analytical, collaborative, and adaptable, with the ability to translate experimental data into actionable insights. Candidates with degrees in Computer Science, Electrical Engineering, or Computer Engineering, or those with purely software-focused backgrounds, are not a fit for this role.

Job Description:
The Digital Data Scientist will support the Combination Product Operations organization by improving the way the company manages and utilizes data to enhance data analysis and decision making within the organization. We are seeking a highly motivated individual who will be primarily responsible for the development and lifecycle management of digital modeling assets and analyzing scientific and combination product performance data. This individual will leverage in-silico and data-driven modeling to evaluate potential opportunities that enable changes in business and operation performance.

The ideal candidate enjoys tackling challenges and excels at enabling insights for decision making using data-driven and physics-based modeling. This may include, but is not limited to, the following:
• Applying engineering principles to develop in-silico models for combination products
• Developing, enhancing, automating, and managing analytics and data-driven models
• Performing ad-hoc analysis and supporting special projects; Providing input to management for trend and failure investigation process improvements
• Demonstrating modeling and visualization approaches as part of proof-of-concept projects
• Transforming ambiguous business and technical questions into measurable and impactful projects
• Demonstrating critical and analytical thinking skills to explore new opportunities in in-silico and data-driven models for combination products.

Skills:

Experience with programming in Python, MATLAB, JMP, and/or Minitab for engineering purposes
Experience with model simulation and analysis (MS&A) techniques for structural, fluidic, and heat transfer problems using commercial software such as ANSYS, LS-Dyna, ABAQUS, COMSOL
Experience with mathematical/first principles modeling, numerical techniques, and uncertainty quantification such as Monte Carlo simulations
Familiar with utilizing GitLab for version control, code collaboration, and project management
Data analysis expertise and statistical or mechanistic modeling experience
Experience in deriving technical recommendations and specifications from the analysis of measured data
Strong communication, presentation, and technical documentation skills are a plus, as is knowledge of process controls
Understanding business needs and developing novel yet practical solutions to meet those needs
Experience with combination products and device regulatory requirements and medical device development and engineering

Preferred Traits:

Passion for proactively identifying opportunities through creative modeling and data analysis
Transform ambiguous business and technical questions into measurable and impactful projects
Partner with multi-discipline digital teams (data analysts, data engineers, data scientists, and business product owners) to advance data analytics tools/features (such as predictive/ prescriptive algorithms and machine learning)
Ability to deliver work and provide positive leadership in a fast-paced, multi-project team-oriented environment
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms and technology rapidly as needs arise
Ability to manage multiple competing priorities simultaneously
Ability to work in highly collaborative, cross-functional environments

Basic Qualifications:
Bachelor's degree in Engineering plus 5 years of simulation, modeling, and data analysis experience Or
Master's degree in Science or Engineering plus 2 years of simulation, modeling, and data analysis experience Or
Ph.D. in Science or Engineering (simulation, modeling, and data analysis)

Top Must Have Skill Sets:

Experience with programming in Python, MATLAB, JMP, and/or Minitab for engineering purposes
Experience with model simulation and analysis (MS&A) techniques for structural, fluidic, and heat transfer problems using commercial software such as ANSYS, LS-Dyna, ABAQUS, COMSOL
Experience with mathematical/first principles modeling, numerical techniques, and uncertainty quantification such as Monte Carlo simulations

Day to Day Responsibilities:

Applying engineering principles to develop in-silico models for combination products
Developing, enhancing, automating, and managing analytics and data-driven models
Performing ad-hoc analysis and supporting special projects; Providing input to management for trend and failure investigation process improvements
Demonstrating modeling and visualization approaches as part of proof-of-concept projects
Transforming ambiguous business and technical questions into measurable and impactful projects
Demonstrating critical and analytical thinking skills to explore new opportunities in in-silico and data-driven models for combination products.

Employee Value Proposition:
Join a leading biopharmaceutical company where innovation and science drive real-world impact. In this Data Scientist role, you’ll work at the intersection of engineering and data analytics, applying your technical expertise to solve complex problems that directly influence drug development and patient outcomes. You'll be part of a collaborative, forward-thinking team in a hybrid environment that values flexibility, professional growth, and cutting-edge technology. With access to world-class resources and the opportunity to contribute to meaningful, life-changing work, this position offers not just a job, but a chance to advance your career while making a difference in global healthcare.

Red Flags:

No Engineering university degree-preferred Mechanical, Chemical, or Biomedical
No engineering background.
Degrees in computer-related fields (CS, CE, EE).

Interview Process:
One phone and one virtual panel interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Packaging C&Q Support - (JP14167) - New Albany, OH

Wed, 14 May 2025 15:38:14 GMT

Job Title: Engineer, Packaging C&Q Support - (JP14043)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process Development Group
Duration: 2+ years (with likely extensions and/or conversion to permanent)
Posting Date: 05/14/2025
Pay Rate: $32 - $37/hour
Notes: Only qualified candidates need apply. Multiple-shift flexibility required. Some potential travel 5%.

3 Key Consulting is hiring an Engineer Senior, Packaging C&Q Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation.

Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms.
Assist with project definition by performing engineering studies and assessment for Packaging Systems installations.
Perform field evaluations of existing systems and provide engineering design recommendations.
Candidates need to be flexible within working shifts.
- This position should not exceed 48 hours a week but, overtime and flexibility will be needed as per Project Executions requirements. Second and third shift will be required as per project execution time needs. Mon-Friday part of the time with weekend shifts during peak project implementation.
  - Examples of working hours:
  - 10-20 % of the time is going to be 8 AM- 5 PM
  - 60 % of the time 2-10 PM
  - 10-20 % of the time 10 PM – 6:30 AM

Why is the Position Open?
Backfill.

Top Must Have Skills:

Bachelor degree minimum
GMP Experience
Flexibility and Team Player

Day to Day Responsibilities:

Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation.
Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms.

Bachelor’s degree minimum
Experience on a GMP environment
Bio-Pharma Knowledge
Team Player

Engineer Principal, Biotech DeltaV, SCADA, PLC - (JP14068) - Thousand Oaks, CA

Tue, 13 May 2025 13:00:13 GMT

Job Title: Engineer Principal, Biotech DeltaV, SCADA, PLC - (JP14068)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Advanced Technology and Automation
Duration: 3 years (with likely extensions and/or conversion to permanent)
Posting Date: 05/13/24
Pay Rate: $80 - $90/hour W2
Notes: Only qualified candidates need apply. Potential need for travel. Possibly visiting vendor sites within the US (once a quarter possibly for a week)

3 Key Consulting is hiring an Engineer Principal for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Ideal candidate:

Must have background in within Life sciences specifically Biotechnology and Biomedical Engineering.
Emerson Delta-V DCS Programming Experience, Rockwell Automation SCADA and PLC Experience, Compliance with regulatory requirements such as 21 CFR Part 11Minimum of Bachelors Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.

Our client’s Manufacturing and Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, is looking for Engineers to support Clinical & Commercial Plant Automation programs and Capital projects, including complex and challenging automation initiatives that require a solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, product lifecycle management, and operational excellence. They will require an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.

Job Responsibilities:

Represent Plant Automation team during the development of project plan, business case, and cost estimates in partnership with key customers and stakeholders – ATO MCS Plant Operations, Engineering, Digital Technology & Innovation (DTI), Global Construction Project Management (GCPM), and provide necessary support to obtain funding approval.
Based on project scope, work with DTI to estimate manhours and required resources using Manufacturing Information and Technology System (MITS).
Represent Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with Engineering and GCPM.
Represent Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
Represent Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and client’s CMDB systems.
Ensure compliance to client’s Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
Represent Plant Automation team and support functional area projects focused on improving process equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug substance and drug product manufacturing technologies into clinical/commercial facility.
As applicable to the capital project scope, represent Plant Automation team and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
Manage day-to-day support of ATO Drug substance operations
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Emerson Delta-V DCS Programming Experience,
Rockwell Automation SCADA and PLC Experience,
Compliance with regulatory requirements such as 21 CFR Part 11

Day to Day Responsibilities:

Represent Plant Automation team during the project implementation of new automation solutions, including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects. 
Represent Plant Automation team during the post-implementation activities, including operationalizing the new assets by extending hyper-care support, training the System Owners and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and client’s CMDB systems. 
Ensure compliance to client’s Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.  
Represent Plant Automation team and support functional area projects focused on improving process equipment/utilities/facilities -to large/sophisticated capital projects to integrate new drug substance and drug product manufacturing technologies into clinical/commercial facilities. 
As applicable to the capital project scope, represent the Plant Automation team and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs. 
Support a safe working environment by complying with applicable environmental health/safety practices, rules, and regulations.

Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product and Supply chain plant operations.
Has five or more years combined experience with the following automation systems:
- Emerson Delta-V DCS system.
- Rockwell Automation SCADA and PLC Platform.
- Electronic Batch Reporting Systems Design and implementation experience.
- Process Control Network design including network segregation.
- Process Control Systems: Virtual Infrastructure design and implementation.
- System Integration using OPC, Foundation Fieldbus, ProfiBus, and DeviceNet technologies.
- Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.

Preferred Competencies:

Proficient in project management skills.
Ability to influence and motivate others outside of direct line of authority.
Strong ability to interface effectively with all levels.
Effective meeting management.
Quick learner; proactive; takes initiative.
Results oriented and goal driven.
Ability to organize, interpret, communicate, and/or present information.
Proficient facilitation, negotiation, problem-solving, and conflict resolution skills.
Strong oral and written communication skills.
Demonstrates willingness to put in extra effort when necessary to pursue tasks and conclusion.

Employee Value Proposition:

Career growth
Opportunity
Networking
Experience

Red Flags:

Not a team player, poor attitude
Poor communicator
Exaggerated or vague job titles and responsibilities
Lack of achievements or quantifiable result

Interview process:
1 with Hiring Manager and 1 with Team. Immediate Availability to start interviewing

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Human Factors Engineer – Onsite (JP14073) - Thousand Oaks, CA

Fri, 09 May 2025 10:30:16 GMT

Job Title: Human Factors Engineer – Onsite (JP14073)
Location: Thousand Oaks, CA. (Onsite only)
Employment Type: Contract
Business Unit: Operations Patient Experience
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 05/09/2025
Pay Rate: Open
Notes: This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hours/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, candidates are local and work in-person in Thousand Oaks, CA. Exceptional candidate with successful experience working remotely may be considered. Due to the prototype build responsibilities, this role is in-person only in Thousand Oaks, CA.

3 Key Consulting is hiring a Senior Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
NOTE: This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hrs/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, we would like candidates to be local and work in-person in Thousand Oaks, CA. Exceptional candidate with successful experience working remotely may be considered. If candidate is within commuting distance to Thousand Oaks, they will be expected to work on-site most/all hours.

Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to document and accurately review and check instruction materials, including Instructions for Use (IFUs) that are used to instruct laypersons in the proper use of combination products/drug delivery devices.
Materials to review will include content copy, layout, line-art illustrations, and other graphical elements for IFUs, carton artwork, and device labeling. Works closely with other designers, HF engineers, and other artwork functions.
In addition to accuracy, role requires instruction checks with quick turnarounds during instruction development to support iterative usability study timelines in a design-test-refine-test model.
Maintains history records of changes to instruction materials to capture rationale for those changes over the development process.
Supports process improvement initiatives, including defining and documenting current procedures within the group and working with cross-functional partners to improve and document labeling across upstream and downstream functions.

Why is the Position Open?
Supplement additional workload on team/ backfill

Top Must Have Skills:

Minimum 4-6 years of experience reviewing documents including medical device IFUs., including strong proficiency in rapid sketch illustration, digital line-art illustration, and image (photo) editing.
2-4 years experience using Adobe Creative Suite software (InDesign and Illustrator) and Microsoft Word and Excel. Knowledge of Microsoft Access and Visio is a plus.
High-level attention to detail and accuracy in reducing errors in work deliverables.
Medical, healthcare, medical devices and/or pharmaceuticals background.
Must be punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects. Strong organization and communication skills.

Day to Day Responsibilities:

Review new and updated IFUs, reference guides, and carton artwork content and graphics (layout and illustrations) for medical device/combination products to ensure accuracy. Some reviews will use digital comparison tools; other reviews will require manual checking.
Maintain change history of instruction materials during their development, including changes from regulatory authorities and Human Factors studies.
Ensure changes to specific projects are communicated to other programs for implementation.
Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate.
Develop instruction design strategies for individual projects that align with department and corporate instruction platforms. Manage individual projects, representing the Instruction Design group, by coordinating with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements and execute on plans.
Support process improvement programs and documentation as it relates to design and development processes.

Employee Value Proposition:

Career growth
Networking
Unique industry experience

Red Flags:

Review experience with text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals, defense user manuals). This role needs applicants with experience reviewing graphics as well as copy.
Only has checking experience; role requires ability to contribute to improving processes involving design and checks.

Interview process:

To be considered, candidates MUST supply an online portfolio
TEAMs/ video conference panel

Senior Human Factors Engineer IFUs & Prototyping – Onsite (JP14072) - Thousand Oaks, CA

Fri, 09 May 2025 10:08:45 GMT

Job Title: Senior Human Factors Engineer IFUs & Prototyping – Onsite (JP14072)
Location: Thousand Oaks, CA. (Onsite only)
Employment Type: Contract
Business Unit: Operations Patient Experience
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 05/09/2025
Pay Rate: Open
Notes: This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hours/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, candidates are local and work in-person in Thousand Oaks, CA. Exceptional candidate with successful experience working remotely may be considered. Due to the prototype build responsibilities, this role is in-person only in Thousand Oaks, CA. There is no relocation for this position.

3 Key Consulting is hiring a Senior Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
NOTE: This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hrs/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, we would like candidates to be local and work in-person in Thousand Oaks, CA. Exceptional candidate with successful experience working remotely may be considered. If candidate is within commuting distance to Thousand Oaks, they will be expected to work on-site most/all hours.

Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination products/drug delivery devices.
IFU creation includes copy, layout, and line-art illustrations. Develops both low- (simple sketch) and high-fidelity digital samples of instructional materials intended for print.
Manages instruction design projects, working closely with other designers, HF engineers, and other related functions.
Supports usability studies with quick turn-around during iterative studies in a design-test-refine-test model.
Balances design thinking with regulatory requirements during development of instructional materials.
Develops instructions for new projects by understanding user needs with HFE partners and applying platform guidelines to create approachable, useful, and effective instructions for users who may be new to the therapy and drug administration.
Hand-builds small batches of prototypes for concept development and for use in usability studies.
Maintains history records to capture rationale for changes over the development of the instructions.
Supports process improvement initiatives, including: defining and documenting current procedures within the group and working with cross-functional partners to improve and document labeling across upstream and downstream functions.

Why is the Position Open?
Supplement additional workload on team/ backfill

Top Must Have Skills:

Minimum 5-10 years of instruction design experience including IFUs, including strong proficiency in rapid sketch illustration, digital line-art illustration, and image (photo) editing. Proficient in Adobe Creative Suite (InDesign, Illustrator, Photoshop), and strong knowledge of InDesign paragraph and character styles. Understands the application of structure and grids for the development of platforms to ensure consistency in output and efficiency in process during instruction creation.
Minimum 3-5 yrs prototyping small volume (10-100 pieces) cartons, leaflets, and labels for use in usability studies. Requires manual assembly and craft-type skills.
Minimum 3-5 years managing design projects and/or teams.
Medical, healthcare, medical devices and/or pharmaceuticals background.
Must be punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects.
High-level attention to detail and accuracy in reducing errors in work deliverables.

Day to Day Responsibilities:

Create and update IFUs, reference guides, and carton artwork content and graphics (layout and illustrations) for new and existing medical device/combination products to ensure accuracy and compliance with applicable regulations, industry standards, and company requirements.
Develop instruction design strategies for individual projects that align with department and corporate instruction platforms. Manage individual projects, representing the Instruction Design group, by coordinating with cross-functional teams (including Human Factors, Device Engineering, Marketing, Labeling, Clinical, Legal and Regulatory Affairs).
Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate.
Maintain change history of instruction materials during their development.
Produce low (quick sketch) to high (refined resolution) fidelity prototypes of IFUs, reference guides, and carton artwork for usability studies. High fidelity prototypes may require plotting, trimming, folding, binding, laminating, and constructing cartons.
Provide expertise and guidance to Human Factors engineering partners and other cross-functional partners with content generation, illustrations, layout, and formatting of instruction materials.
Support process improvement programs and documentation of cross-functional processes.
Manage junior staff and/or oversee external vendors to execute design work.
Troubleshoot relatively complex problems and issues.

Employee Value Proposition:

Career growth
Networking
Unique industry experience

Red Flags:

Only academic experience
Past experience exclusively in marketing, branding, logos, websites without any experience writing instructions for regulated products
Only junior-level experience designing; we need senior-level experience and thinking for this role. Requires experience managing design projects and working with multiple stakeholders
Text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals, defense user manuals)
No prototyping experience.

Interview process:
To be considered, candidates MUST supply an online portfolio

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Human Factors Engineer IFUs – REMOTE (JP14071) - Thousand Oaks, CA

Fri, 09 May 2025 09:50:59 GMT

Job Title: Senior Human Factors Engineer IFUs– REMOTE (JP14071)
Location: Thousand Oaks, CA. (REMOTE)
Employment Type: Contract
Business Unit: Operations Patient Experience
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 05/09/2025
Pay Rate: Open
Notes: This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hours/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, candidates are local and work in-person in Thousand Oaks, CA. Exceptional candidate with successful experience working remotely may be considered. If the candidate is within commuting distance to Thousand Oaks, CA. they will be expected to work on-site most/all hours. There is no relocation for this position.

3 Key Consulting is hiring a Senior Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
NOTE: This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hrs/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, we would like candidates to be local and work in-person in Thousand Oaks, CA. Exceptional candidate with successful experience working remotely may be considered. If candidate is within commuting distance to Thousand Oaks, they will be expected to work on-site most/all hours.

Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination products/drug delivery devices.
IFU creation includes copy, layout, and line-art illustrations. Develops both low- (simple sketch) and high-fidelity digital samples of instructional materials intended for print.
Manages instruction design projects, working closely with other designers, HF engineers, and other related functions.
Supports usability studies with quick turn-around during iterative studies in a design-test-refine-test model.
Balances design thinking with regulatory requirements during development of instructional materials.
Develops instructions for new projects by understanding user needs with HFE partners and applying platform guidelines to create approachable, useful, and effective instructions for users who may be new to the therapy and drug administration.
Maintains history records to capture rationale for changes over the development of the instructions.
Supports process improvement initiatives, including: defining and documenting current procedures within the group and working with cross-functional partners to improve and document labeling across upstream and downstream functions.

Why is the Position Open?
Supplement additional workload on team/ backfill

Top Must Have Skills:

Minimum 5-10 years of instruction design experience including IFUs, including strong proficiency in rapid sketch illustration, digital line-art illustration, and image (photo) editing. Proficient in Adobe Creative Suite (InDesign, Illustrator, Photoshop), and strong knowledge of InDesign paragraph and character styles. Understands the application of structure and grids for the development of platforms to ensure consistency in output and efficiency in process during instruction creation.
Minimum 3-5 years managing design projects and/or teams.
Medical, healthcare, medical devices and/or pharmaceuticals background.
Must be punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects.
If remote, must have experience working remotely from others in team.
High-level attention to detail and accuracy in reducing errors in work deliverables.

Day to Day Responsibilities:

Create and update IFUs, reference guides, and carton artwork content and graphics (layout and illustrations) for new and existing medical device/combination products to ensure accuracy and compliance with applicable regulations, industry standards, and company requirements.
Develop instruction design strategies for individual projects that align with department and corporate instruction platforms. Manage individual projects, representing the Instruction Design group, by coordinating with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements and execute on plans.
Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate.
Maintain change history of instruction materials during their development.
Provide expertise and guidance to Human Factors engineering partners and other cross-functional partners with content generation, illustrations, layout, and formatting of instruction materials.
Support process improvement programs and documentation of cross-functional processes.
Manage junior staff and/or oversee external vendors to execute design work.
Troubleshoot relatively complex problems and issues.

Employee Value Proposition:

Career growth
Networking
Unique industry experience

Red Flags:

Only academic experience
Past experience exclusively in marketing, branding, logos, websites without any experience writing instructions for regulated products
Only junior-level experience designing; we need senior-level experience and thinking for this role. Requires experience managing design projects and working with multiple stakeholders
Text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals, defense user manuals)

Engineer Principal, DeltaV Automation - (JP14069) - Thousand Oaks, CA

Thu, 08 May 2025 18:51:25 GMT

Job Title: Engineer Principal, DeltaV Automation - (JP14069)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Advanced Technology and Automation
Duration: 3 years (with likely extensions and/or conversion to permanent)
Posting Date: 05/08/2025
Pay Rate: $90 - $100/hour on W2 (DOE) with Benefits
Notes: Only qualified candidates need apply. Onsite, 5 days per week, regular business hours (8:30 AM - 5:30 PM) NO RELOCATION. On-call requirement: Minimal (rotational approximately every 7 weeks; typically 1-hour calls weekly)

3 Key Consulting is hiring an Engineer Principal, DeltaV Automation for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate for the Principal Automation Engineer (Delta V) role:

Extensive expertise in Delta V batch control systems, with a minimum of 4–5 years of direct, hands-on Delta V experience specifically in pharmaceutical manufacturing environments.
Demonstrate proficiency in coding, troubleshooting, and addressing complex alarms or system issues in Delta V.
Hold a Bachelor’s degree (Chemical, Electrical, Automation Engineering, Computer Science, Electronics, or similar technical field). Substantial practical Delta V experience can outweigh formal educational qualifications.
Strategic mindset, excellent troubleshooting skills, and strong interpersonal capabilities are crucial, as the role involves frequent collaboration across various teams.
Experience in PLC systems and Delta V system administration is beneficial but not mandatory.
Must show a track record of stability in their previous employment, with demonstrated capacity for maintaining long-term roles.

Job Details:

Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
Lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
Work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
Work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:

Emerson Delta-V DCS system with batch control and recipe management
System Integration using OPC, Profibus, EIP, WIOC, and DeviceNet technologies.
DeltaV Virtual infrastructure configuration, management, and troubleshooting

Day to Day Responsibilities:

Develop and maintain process control automation solutions using DeltaV Distributed Control System (DCS).
Lead or support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
Lead or support new technology introductions (NTI) and new product introductions (NPI) by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as needed.
Identify and implement continuous improvement projects that align with client initiatives around Safety, Reliability, Efficiency and Environmental sustainability.
Maintain automation system health and resiliency via cybersecurity, data integrity, and preventative maintenance in alignment with the latest client and industry standards
Align and standardize code implementation within the DSS plant network.
On-site production support during normal business hours and on-call support after hours
Refining or creating business process improvements including departmental Standard Operating Procedures (SOP).
Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
Create and assess product requirements to determine technical coverage and proper integration different subsystems.
Create and execute to project plans and schedules
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Provide deep technical assistance for junior engineers.

Basic Qualifications:

Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience

BS in Engineering and previous experience in a medical device industry
10 years current experience with engineering processes and procedures.
Led projects from development through the 510k and PMA approval process.
Strong background in engineering and commercialization of electro-mechanical medical devices.
Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in drug/device combination product design and development
Familiar with the following standards:
- Quality System Regulation 21CFR820
- Risk Management ISO 14971
- EU Medical Device requirements
- Council Directive 93/42/EEC
- Medical Electrical Equipment
- EN 60601
Small scale device assembly experience.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Strong problem solving, risk assessment, and risk management skills.
Must be capable of working on multiple projects in a deadline driven environment.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!

Red Flags:

Lack of Delta V experience (immediate disqualification)
Candidates requiring sponsorship (possible but less preferred)
History of frequent short-term roles indicating instability or inability to maintain employment

Interview process:
Panel interviews with current team and adjacent senior managers.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Data Collection, Extraction & Analysis - Medical Devices (JP14034) - Cambridge, MA

Wed, 07 May 2025 14:30:02 GMT

Job Title: Engineer – Data Collection, Extraction & Analysis Medical Devices (JP14034)
Location: Cambridge, MA. 02138
Employment Type: Contract
Business Unit: Combination Product Stewardship
Duration: 18 months (with likely extensions and/or conversion to permanent)
Posting Date: 05/07/25
Pay Rate: $36 - $41/hour W2 only
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring an Engineer - Data Collection, Extraction & Analysis Medical Devices for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
We are seeking an enthusiastic and detail-oriented Engineer to join the Combination Product Operations Digital and Data Strategy team. The ideal candidate will design, implement, and optimize digital workflows, ultimately improving efficiency, reducing operational costs, and enhancing the overall performance of the organization. Additionally, the individual will play a key role in creating and delivering insightful reports to inform decision-making. The Engineer will work within a cross-functional organization to ensure successful and efficient onboarding and adoption of Digital capabilities for various business groups with our client.

Why is the Position Open?
Additional hands for current workload.

Top Must Have Skills:

Prefer experience post-graduation

Technical writing
Experience performing data analysis. (Power BI, Tableau, Spotfire)

Interest in working with large quantities of data to enable general workflows such as data processing, cleaning, and labeling.
Strong communication skills and ability to demonstrate and relay technical concepts to different audiences.

Day to Day Responsibilities:

Data Collection and Extraction:
- Retrieve and preprocess data from various sources, such as databases, APIs, and flat files.
- Initiating and supporting the digitalization of experimental workflows.
- Identify areas for improvement, enhance efficiency, and reduce errors in streamlining data capture to reporting.
Data Visualization:
- Create informative data visualizations using tools like PowerBI, Tableau, and Spotfire.
- Communicate findings to technical and non-technical stakeholders through charts, graphs, and dashboards.
- Collaboration and Reporting:
- Collaborate with cross-functional teams to understand their data requirements and provide data-driven solutions.
- Generate regular reports and presentations to communicate insights and recommendations.
- Perform report validations
- Perform system installation qualification and operational qualifications
- Create documentation to support digital processes, systems, or stakeholder needs.

Basic Qualifications:

Bachelor's degree in Engineering plus 2 years of engineering or data analysis experience, OR;

Master's degree in Engineering

Experience performing data analysis.
Interest in working with large quantities of data to enable general workflows such as data processing, cleaning, and labeling.
Strong communication skills and ability to demonstrate and relay technical concepts to different audiences.
Ability to manage multiple, competing priorities simultaneously.
Ability to deliver work in a fast-paced, multi-project team-oriented environment.
Ability to work in highly collaborative, cross-functional environments.

Preferred Qualifications:

Experience with data science libraries.
Experience in programming languages, such as Python or R.
Experience with combination products, device regulatory requirements, medical device development and engineering, and process controls.
Provide Digital and Data expertise for the different product teams to ensure consistent data model and FAIR (Findable, Accessible, Interoperable & Reusable) data design across the various capabilities implemented.
Identify improvements required to data and attribute models and drive engagement with internal and external stakeholders (incl. software vendor) to obtain enhancements.

Employee Value Proposition:
This role will enable to develop your data analysis skills, implement processes in a corporate environment and gain experience in a GMP environment.

Red Flags:

Lack of Engineering or Computer Science background
Short previous job durations (Less than 6 months)
Lack of technical writing skills

Interview process:
Phone Screening
Interview panel 1 - Video
Interview panel 2 - In Person

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer - Biotech (JP14019) - Thousand Oaks, CA

Tue, 06 May 2025 17:33:51 GMT

Job Title: Associate Engineer - Biotech (JP14019)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Final Product Technologies, Process Engineering
Duration: Initial 6 months with possible extensions and/or conversion to permanent position
Rate: $30 - $34/hour W2 with Benefits
Posting Date: 05/6/25

Notes:
Hybrid: Onsite: 3–4 days/week depending on testing schedule. Remote when no testing is planned
Duration: Initially 6 months; possible extension up to 18 or 36 months.

3 Key Consulting is hiring an Associate Engineer, for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal candidate:
The ideal candidate will hold a bachelor’s degree in Engineering (Biotech, Chemical, or Mechanical) or Life Sciences. Candidates with an associate degree and at least four years of relevant experience will also be considered. Fresh graduates are welcome, provided they have academic or research lab experience. Hands-on testing or laboratory experience is strongly preferred, while familiarity with GMP/GDP environments is a plus but not required. Candidates should possess strong written and verbal communication skills, be comfortable working under SOPs, and be capable of lifting up to 50 lbs to move lab shippers. Experience supporting projects through protocol reviews or documentation is valuable, as is exposure to tools like SharePoint or Smartsheet, though this is not mandatory.

Job Details:
This position will be mostly on-site at Thousand Oaks with the ability to work remotely on occasion. Candidate should be within commutable distance, and should be available to work on site at any time. Time spend in lab will be hands on and will require the candidate to be on their feet the majority of the time. Possibility of extension.

Standout Candidate:

Lab Experience- testing execution in Bio Med or Bio Tech Company
Communication Skills- communicate with cross-functional teams to coordinate testing samples and schedules.
Following SOP's is very important to execute testing and remain in compliance.

This Associate Engineer position is in the Thermal Engineering Systems (TES). The individual will apply engineering principles and follow current SOPs to execute lab related testing per approved protocols. Under supervision by senior personnel, the individual will set up a variety of equipment and instruments, conduct experimental studies, and document the results following SOPs.

Responsibilities

Execute all lab related testing per test protocols in accordance with operating standards, SOPs and regulatory requirements, while understanding safety precautions
Operate all lab equipment, e.g., Vibration Systems, Environmental Chambers, and Vacuum Systems
Responsible for planning and scheduling all lab related activities, such equipment calibration, maintenance, lab tour, etc.
Manage lab budget/expense and supply inventory levels to satisfy testing demand
Able to troubleshoot and perform general maintenance on equipment to keep a test running
Collaborate with cross-functional teams (i.e. Research and Development, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory) on protocol review, testing preparation, change control process, deviation & CAPA, and controlled documentation
Ensure cGMP and regulatory compliance are met
Assist Engineers with internal experiments and studies; provide guidance on test method to be used
Able to lift up to 60 lbs repeatedly without assistance
Proficient in MS Office Suite (Excel, Word, Visio, PPT, etc)

Qualification:

Engineering or Science degree: biotechnology, chemical or mechanical preferred;
Prior lab/manufacturing/production experience/knowledge in GMP/GLP environment;
Evidence of completing engineering tasks according to SOPs or instructions;
Knowledge of industry testing standards, i.e. ASTM and ISTA, is a plus;
Experience in the Bio-Tech or Pharmaceutical Industry preferred;
Good oral/written communication skills;
Ability to prioritize tasks and maintain functionality in the lab

Top Must Have Skills:

Knowledge of cGMP-Bio/Pharma background
Lab testing experience/knowledge and lab management
Proven written and oral communication skills

Day to Day Responsibilities:

Execute all lab related testing per test protocols
Operate & maintain all lab equipment and manage budget/expense & inventory
Plan and schedule all lab related activities
Author and revise controlled documents in document management system
Conduct characterization studies for TES projects

Candidates who lack relevant skills
Candidates who do not meet the qualification requirements
Candidates who were separated from previous employment due to unethical behaviors
Candidates without lab or hands-on experience (even at academic level)
Candidates without relevant coursework or research tied to biotech, engineering, or lab sciences

Interview process:
One-on-one phone screening, followed by an in-person 1:6-10 person group interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Associate, Testing & Analysis Drug Product Medical Device - (JP13997) - Thousand Oaks, CA

Thu, 24 Apr 2025 15:37:05 GMT

Job Title: Engineer Associate, Testing & Analysis Drug Product Medical Device - (JP13997)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Final Product Technologies
Duration: 24 months with possible extensions and/or conversion to permanent position
Rate: $30 - $34/hour W2 with Benefits
Posting Date: 04/24/25
Notes: Role is expected to be onsite 5 times a week. Please send in local candidates. candidates who either live within a 50-mile drive or would be willing to relocate.

3 Key Consulting is hiring an Engineer Associate, Testing & Analysis Primary Drug Product Containers for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal candidate: flexible with overtime during the week when necessary. Rarely will they need to work over 12 hours in a day. Preferring bachelor’s degree in Bioscience or Engineering.

Job Details:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for primary containers (vials, stoppers, and syringes) and medical devices.
Responsibilities include:

Employing basic science and engineering skills and practices to gather user requirements and translate them into technical documentation for execution
Assisting with project definition by performing engineering studies and assessments

Skills:

Previous lab experience
Strong oral and verbal communication and presentation skills
Experience in analysis of data generated from a variety of analytical techniques is preferred

Top Must Have Skills:

Technical writing skills
Strong ability to analyze data generated from a variety of analytical techniques and systems is preferred
Previous lab experience in Engineering or Biochemistry labs is helpful but not required
Strong oral and verbal communication and presentation skills
Experience in analysis of data generated from a variety of analytical techniques is preferred

Day to Day Responsibilities:

Assist in designing studies and drafting protocols
Assist in compiling historical data from different analytical systems
Assist in analyzing data and presenting results
Assist in writing summary reports
Executing protocols, including lab testing (using vacuum decay leak tester, Instron force testers, balances, microscopes, pressure chambers, analytical measurement equipment such as calipers, optical comparators, bore gauges, automated stoppering units, pipettes, and decrimpers).

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Employee Value Proposition:
Unique industry opportunity
Career growth
Networking

Red Flags:
- Candidate has inflexible schedule
- Candidate cannot work possible overtime
- Candidate cannot work onsite at Thousand Oaks, CA
- Bachelor’s degree not in Bioscience or Engineering
- No experience working in a lab
- No technical writing skills

Interview process:
One-on-one phone screening, followed by an in-person 1:6-10 person group interview
Interviews can start immediately

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Validation Engineer, Biotech Facilities & Engineering (JP13958) - Thousand Oaks, CA

Tue, 22 Apr 2025 15:50:00 GMT

Job Title: Senior Validation Engineer, Biotech Facilities & Engineering (JP13958)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Product Supply
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $60 - $70/hour (DOE) - W2 with benefits
Posting Date: 4/22/2025.

3 Key Consulting is hiring! We are recruiting a Senior Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description & Responsibilities:

Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment.
Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
Arrange and implement FAT/SAT, commissioning activities for new GMP systems in collaboration with both internal and external partners.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in a technical or natural scientific field.
Demonstrable experience in a pharma organization within a C&Q/CQV corresponding role.
Knowledge of qualification needs to cGMP guidelines.
Familiarity with Kneat Gx Platform or other digital C&Q systems.
Familiarity working with cross-department stakeholders.
Knowledge of quality assurance principles.
Experience working within project teams and various projects in parallel.
Prior involvement working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
Effective communication skills, both verbally and in writing.
Able to think analytically with the ability to resolve issues.
Able to manage own time efficiently.

Top Must Have Skill Sets:

Experience in a GMP environment
Experience generating C&Q protocols & executing C&Q protocols
7+ years of relevant experience

Day to Day Responsibilities:

Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
Creating new test methods and the required test fixtures.
Creating all the required documents for qualification, validation and transfer of test methods.
Create, revise parts and drawings using CAD software (SolidWorks Preferred).
Perform data analysis using Minitab and interpret data.
Performing and operating the tests required for qualification, validation and transfer of the methods.
Creating training documents.
Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Why is the Position Open?
Supplement additional workload on team

Interview Process:
Microsoft Teams followed by panel interview.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Validation Engineer, Biotech Facilities & Engineering (JP13959) - Thousand Oaks, CA

Tue, 22 Apr 2025 15:43:28 GMT

Job Title: Validation Engineer, Biotech Facilities & Engineering (JP13959)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Product Supply
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $42 - $52/hour - W2 with benefits
Posting Date: 4/22/2025.

3 Key Consulting is hiring! We are recruiting a Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description & Responsibilities:

Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment.
Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
Arrange and implement FAT/SAT, commissioning activities for new GMP systems in collaboration with both internal and external partners.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in a technical or natural scientific field.
Demonstrable experience in a pharma organization within a C&Q/CQV corresponding role.
Knowledge of qualification needs to cGMP guidelines.
Familiarity with Kneat Gx Platform or other digital C&Q systems.
Familiarity working with cross-department stakeholders.
Knowledge of quality assurance principles.
Experience working within project teams and various projects in parallel.
Prior involvement working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
Effective communication skills, both verbally and in writing.
Able to think analytically with the ability to resolve issues.
Able to manage own time efficiently.

Top Must Have Skill Sets:

Experience in a GMP environment
Experience generating C&Q protocols & executing C&Q protocols

Day to Day Responsibilities:

Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
Creating new test methods and the required test fixtures.
Creating all the required documents for qualification, validation and transfer of test methods.
Create, revise parts and drawings using CAD software (SolidWorks Preferred).
Perform data analysis using Minitab and interpret data.
Performing and operating the tests required for qualification, validation and transfer of the methods.
Creating training documents.
Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Why is the Position Open?
Supplement additional workload on team

Interview Process:
Microsoft Teams followed by panel interview.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Associate, Testing & Analysis Primary Drug Product Containers - (JP13895) - Thousand Oaks, CA, CA

Wed, 16 Apr 2025 20:21:05 GMT

Job Title: Engineer Associate, Testing & Analysis Primary Drug Product Containers - (JP13895)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Final Product Technologies
Duration: 18+ months (with likely extensions and/or conversion to permanent)
Rate: $30 - $34/hour W2 only
Posting Date: 04/16/25
Notes: Only qualified candidates need apply. On site 3 days per week. Local candidates. Will consider candidates willing to relocate.

3 Key Consulting is hiring an Engineer Associate, Testing & Analysis Primary Drug Product Containers for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate will have flexibility with overtime during the week when necessary. Rarely will they need to work over 12 hours in a day. The candidate will have a bachelor’s degree in engineering (mechanical, biomedical, or bioengineering) or bioscience, or equivalent relevant experience in biomanufacturing. Hands-on lab experience, academic or professional, is strongly preferred, along with familiarity using testing equipment such as Instron force testers, CCI testers, or CT scanners.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for primary containers (vials, stoppers, and syringes) and medical devices. The role involves executing laboratory tests, supporting investigations, drafting protocols and reports, organizing test data, and contributing to process improvements. Strong technical writing skills, attention to detail, and an analytical mindset are essential. Candidates should be adaptable, collaborative, and eager to learn in a fast-paced, hands-on environment.

Responsibilities include:

Employing basic science and engineering skills and practices to gather user requirements and translate them into technical documentation for execution
Assisting with project definition by performing engineering studies and assessments

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Technical writing skills
Strong ability to analyze data generated from a variety of analytical techniques and systems is preferred
Previous lab experience in Engineering or Biochemistry labs is helpful but not required
Strong oral and verbal communication and presentation skills
Experience in analysis of data generated from a variety of analytical techniques is preferred

Day to Day Responsibilities:

Assist in designing studies and drafting protocols
Assist in compiling historical data from different analytical systems
Assist in analyzing data and presenting results
Assist in writing summary reports
Executing protocols, including lab testing (using vacuum decay leak tester, Instron force testers, balances, microscopes, pressure chambers, analytical measurement equipment such as calipers, optical comparators, bore gauges, automated stoppering units, pipettes, and decrimpers).

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Red Flags:

Candidate has inflexible schedule
Candidate cannot work possible overtime
Candidate cannot work onsite at Thousand Oaks, CA
Bachelor’s degree not in Bioscience or Engineering

Interview process:
One-on-one phone screening, followed by an in-person 1:6-10 person group interview
Interviews can start immediately

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – E2E Pivotal Drug Substance Development (JP13969) - Cambridge, MA

Wed, 16 Apr 2025 14:59:00 GMT

Job Title: Engineer – E2E Pivotal Drug Substance Development (JP13969)
Location: Cambridge, CA. 02138
Employment Type: Contract
Business Unit: AMA Pilot Plant
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Rate: $36 - $41/ hour
Posting Date: 04/19/25
Notes: Only qualified LOCAL candidates need apply. Must have lab or relevant industry experience and at least one year working on similar projects*

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
*** The candidate must have lab or relevant industry experience and at least one year working on similar projects

*** Ideal Candidate: B.S. graduate with some work experience. Around 1+ YOE is ideal.
Nice to have: Maintenance background; hands-on experience with equipment support and troubleshooting.

The Pivotal Drug Substance Technologies organization at our client is seeking a skilled Engineer to join their team. This lab-based position that involves developing, characterizing, and supporting clinical drug substance manufacturing processes for late-stage programs in their product portfolio. The Pivotal Drug Substance Technologies organization at our client develops, characterizes and supports clinical drug substance manufacturing processes for all late-stage programs in their product portfolio.

This lab-based position is located at our Cambridge, MA site. The successful candidate will be responsible for the development, characterization and scale-up of upstream and downstream processes to enable clinical advancement of programs. The candidate will also be responsible for equipment maintenance and reliability. This role will include project-based work managed by the candidate.

This role is in an integrated bioprocess development group in which cell culture and purification scientists work together to advance client’s rich, exciting and dynamic pipeline. With their approach, the position provides the unique opportunity to work on multiple modalities including antibodies, BiTEs, and bispecifics.

The successful candidate will design and execute experiments spanning the end-to-end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges. Additionally, the candidate will utilize out-of-the-box thinking to contribute to laboratory operations, technology development, and process automation. Finally, the candidate will also expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group.

Top Must Have Skills:

Organized project work
Proactive troubleshooting
Collaborative project experience
Asset management experience

Day to Day Responsibilities:

Ensure preventative maintenance is performed on equipment
Coordinate and organize project work
Support continuous improvement projects

Cell Culture and Bioreactor Management: Culturing mammalian cells, maintaining bench-scale bioreactors, and sampling bioreactors.
Process Analytical Technologies (PAT): Utilizing PAT for process monitoring, optimization, and control.
Data Analysis: Compiling and analyzing experimental data to support process development and optimization.
Equipment Maintenance: Ensuring equipment reliability and performing routine maintenance.
Project Management: Managing project-based work and collaborating with cross-functional teams.
Experiment Design and Execution: Designing and executing experiments spanning cell culture and purification operations, applying established platform approaches, and solving day-to-day experimental challenges.
Innovation and Technology Development: Contributing to laboratory operations, technology development, and process automation through innovative thinking.

Master’s degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence.
Ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment.
Prior experience with high throughput systems (such as the AMBR) or PAT.
Prior experience with project management.
Motivated self-starter with excellent interpersonal and organizational skills. Team player with the ability to successfully work within a diverse team in a dynamic, cross-functional environment.
Familiarity with design of experiments and statistical analysis of data desirable.
Prior experience with data analytical tools (Excel, Spotfire, Python etc.)

Red Flags:

Low GPA. Non-scientific major / experience.
Candidates must be willing to grow and develop.
Job hopping.

Interview process:
MS teams screen followed by in-person panel interviews.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Test Engineer, Technical Investigator, Medical Device (JP13934) - Thousand Oaks, CA

Sat, 12 Apr 2025 17:29:16 GMT

Job Title: Test Engineer, Technical Investigator, Medical Device (JP13934)
Location: Thousand Oaks, CA. 91320
Business Unit: Complaints Trending
Employment Type: Contract
Duration: 12 months with possible extensions or conversion to FTE
Rate: $36-42 W2 with benefits
Posting Date: 04/12/2025.
Notes: Only qualified candidates need apply. Onsite 80% of time as needed (local candidates).

3 Key Consulting is hiring! We are recruiting an Engineer, Technical Investigator Medical Device for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal candidate:

3 years of experience performing failure analysis investigations within a medical device environment, specifically class II or class III devices.
Proficient with ISO systems, risk analysis processes, and protocol or report writing.
A bachelor's degree in engineering or sciences such as chemistry, physics, or biology is strongly preferred, though candidates with other educational backgrounds who possess robust laboratory experience will also be considered.
Experience working in biohazard lab settings is a plus, but not mandatory.
Excellent written and verbal communication skills, along with strong presentation abilities, are essential as the role involves regular presentations to internal teams.
Candidates must have a background in medical devices, biotech, or biopharma industries and must be local, able to commute onsite 2–3 days per week (ideally residing within Los Angeles, Orange, or Ventura Counties).
This role will begin as a one-year contract, with the potential for extension.

Engineer - Complaints Technical Investigator:
Requires a combination of working remote and going onsite 2 to 3 times per week (average) for complaint returns assessment and/or laboratory equipment setup, development and validation of test methods.

Job Description:
Our client is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of Company’s mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of Company’s packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.

Top Must Have Skill Sets:

3+ years of experience in failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
Experience with protocol and report writing, process and test development and execution, and design of experiments

Day to Day Responsibilities:

Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends
Provide input to engineering for product improvements
Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms
Lead root cause analysis to identify the failure mode for Company’s products and associated components due to product complaint
Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, “5 Whys”, risk assessments such as FMEA’s, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.
Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation
Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Master’s Degree in Science
3 years experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
Understand customer / patient use of Company’s packaged and/or distributed products
Understand manufacturing processes for Company’s packaged and/or distributed products
Proven experience with medical devices
Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
Experience with protocol and report writing, process and test development and execution, and design of experiments
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Strong technical writing and interpersonal skills

Why is the Position Open?
Supplement additional workload on team.

Red Flags:
Must be local to ATO or willing to relocate immediately.
Must be willing to be on site 2-3 days per week.
Must be familiar with good laboratory practices (GLP)

Interview Process:
Interview with Sr. Engineer, Lab Captain, and Associate Director of C&TI and others as necessary.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Biotech Product Complaint (JP13929) - Thousand Oaks, CA

Fri, 11 Apr 2025 10:22:29 GMT

Job Title: Associate Engineer, Biotech Product Complaint (JP13929)
Location: Thousand Oaks, CA. 91320 - Hybrid
Business Unit: Complaints Trending
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $32 - $36/hour W2
Posting Date: 04/11/2025
Notes: Must be local to be onsite.

3 Key Consulting is recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to Principal Engineer in the Complaints Trending and Investigation group. In support of the company’s mission to serve patients, the Complaints Trending and Investigation group is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize patient experience.

The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis as well as supporting/leading root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the CT&I lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.

Responsibilities:

Perform device assessments of complaints and document results in a report.
Perform root cause analysis investigations for mechanical and/or electromechanical products
Complete evaluation and deliver assessment report on time per Company’s requirements.
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
Support characterization testing and data gathering for investigations

Preferred Qualifications

Master’s or bachelor’s in engineering, Science or Biomedical 2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience in lab environment
Demonstrated competency in root cause analysis methodology
Experience with assessment writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented

Top Must Have Skill Sets:

Strong technical, analytical and problem-solving skills
Strong interpersonal, communication, and teamwork skills
Skills and experience in lab environment

Day to Day Responsibilities:

Perform device assessments of complaints using equipment such as CT scanner, microscope and other measurement/imaging equipment in a laboratory environment and document results in a report.
Onsite 80%, must be available to go onsite when needed.

Senior Engineer, MES PAS-X Software - Biopharma – Hybrid (JP13918) - Thousand Oaks, CA

Wed, 09 Apr 2025 15:15:17 GMT

Job Title: Senior Engineer, MES PAS-X Software - Biopharma – Hybrid (JP13918)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: NPI/EBR Support
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $70 - $78/hour on W2 With benefits
Posting Date: 4/9/2025.
Note: Hybrid - Thousand Oaks, CA - Approximately 1 day per week onsite

3 Key Consulting is hiring! We are recruiting a Senior Software Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: 5-10 years of experience.

Manufacturing Execution System (Kroeber PAS|X) designer / validation experience
Experience with Enterprise Resource Planning (SAP) software
Experience with biotech manufacturing (Drug Product process)
Strong project management skills - This person needs to be comfortable coordinating projects.

Job Description:
Support Drug Substance Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics, and for communication between the GMP operations teams and the process development scientific groups. This position will be focused on Electronic Batch Records for Drug Substance manufacturing.

Job scope and responsibilities:

Manufacturing Electronic Batch Record (EBR) generation using PAS-X (Korber)
Validation of new Electronic Batch Records (Application Lifecycle Management)
Assisting in implementation of new MES functionality
Develop standard work and business practices for new MES functionality
Contributing to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
Participate and contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.

Top Must Have Skill Sets:
MUST have strong PAS-X software experience for electronic batch records with detailed understanding of editing and validation
Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV, Rockwell)
Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing

Basic Qualifications:
Doctorate Degree OR Master Degree and 3 years of Engineering experience OR Bachelor Degree and 5 years of Engineering experience OR Associate degree and10 years of Engineering experience

Preferred Qualifications:

Experience with PAS X (Korber) software for electronic batch records with detailed understanding of editing and validation
Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing
Demonstrated ability to work in a team
Degree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology

Red flags:

Lack of soft / project management skills to work cross-functionally and develop a project plan
Lack of ability to be punctual toward the project plan
Lack of independence / self-starter mentality toward understanding the manufacturing process and imposing electronic batch record requirements around it
Lack of top 3 skillsets.

Why is the Position Open?
Supplement additional workload on team

Interview Process:
1) Phone Screening (Logistics and General knowledge questions)
2) Panel Interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, IT Business & Automation Systems Validation (JP13827) - New Albany, OH

Fri, 04 Apr 2025 16:16:02 GMT

Job Title: Engineer Senior, IT Business & Automation Systems Validation (JP13827)
Location: New Albany, OH. 43054
Business Unit: Ops DTI
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $50 - $60/hour W2 DOE with Benefits
Posting Date: 04/04/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Business & Automation Systems Validation for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer-related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of our client’s Ohio's computer systems validation.

•   Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
•   Provide support to system owners on completion of Design Specifications, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
•   Provide support to complete the validation deliverables as required per the project.
•   Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
•   Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
•   Perform system periodic reviews for Computerized systems, Automation systems.
•   Familiar with validating SCADA, MES, PI Factory Talk Historian, Serialization systems.
•   Ensures that systems are maintained in a compliant manner according to the Technology quality systems standards.
•   Support regulatory inspections and internal audits as required.

Top Must Have Skill Sets:
•   Experience with ALM or Kneat testing tool is plus.
•   Experience with ServiceNow (Problem, Change management), Track wise (Change Management), Veeva (Document management, CAPA, Deviations, Change Management).
•   Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
•   Understanding of industry standards and best practices for computer system validation such as GAMP 5.
•   Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).

Day to Day Responsibilities:
•   Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
•   Provide support to system owners on completion of Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
•   Provide support on completion of validation deliverables as required per the project.
•   Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
•   Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
•   Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
•   Support regulatory inspections and internal audits as required.

Basic Qualifications:
•   Bachelor’s or Master’s Degree in a science or Engineering discipline required.
•   7+ years relevant experience in computer system validation (E.g: MES, SCADA, PI Factory Talk Historian, Building Management system (BMS, QBAS), Serialization, QC systems).
•   Basic Qualifications

Red Flags:
•   No experience on computer validation process.
•   No background from life Sciences/Bio Technology.
•   No experience on system deviations, CAPA, Change management.
•   No knowledge on data integrity ALCOA, ALCOA+ principles.

Interview Process:
Webex, or In-person

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Biotech Packaging Line Equipment (JP13921) - New Albany, Oh

Thu, 03 Apr 2025 16:03:54 GMT

Job Title: Engineer, Biotech Packaging Line Equipment (JP13921)
Location: New Albany, OH. 43054
Business Unit: Assembly & Packaging Chimera
Employment Type: Contract
Duration: Initial 6 months with likely extensions or conversion to FTE
Rate: $40-50/Hr or open market rate DOE, W2 with Benefits
Posting Date: 4/3/2025.
Note: seeking 3+ years of experience

3 Key Consulting is hiring! We are recruiting Engineer (Mechanical) - Biotech Packaging Lines Equipment for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
In this role the Line Owner/System Owner must work under general supervision, owning all the technical aspects in a manufacturing line. The processes where the SO/LO Engineer shall be familiar with are:

Characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects.
Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

As a technical resource of an area, System owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. At the same time, the System Owner/Line Owner Engineer shall be able to define designs requirement to the service providers to fulfill area technical and equipment needs.

Top Must Have Skill Sets:

Experience with packaging equipment, specifically pharmaceutical, food, or beverage.
Experience with GMP environments.
Good communication skills, troubleshooting skills, and a team player.
Looking for Mechanical engineer over an industrial engineer (industrial is OK with relevant experience)

Day to Day Responsibilities:
Specific responsibilities include but are not limited to:

Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
Initiate and complete routine technical tasks.

Operations Engineering:

Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.

Design Engineering:

Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects and engineering firms on development of standard design documents.
Acquire and critique quotes for equipment modifications or installations.
Generate rudimentary project cost estimates and schedules.

Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
Knowledge of pharmaceutical/biotech processes
Familiarity with validation processes for Packaging areas
Familiarity with serialization process and networking
Familiarity with documentation in a highly regulated environment
Ability to operate specialized equipment, tools and computers as appropriate.
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
Ability to apply engineering science to production.
Able to develop solutions to routine technical problems of limited scope
Comprehensive understanding of protocol requirements.
Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
Excellent communication (verbal/written) and presentation skills
Demonstrated interpersonal skills including; collaboration, influencing, and facilitation
Protocol and script testing Writing
Dealing with and handling change
Packaging Equipment Technical knowledge
Analytical Problem Solving
Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context

Why is the Position Open?
Supplement additional workload on team.

Red Flags:
Misspellings in Resume.
Long Resumes without descriptive content.

Interview Process:
One phone and one virtual panel interview.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Needle-Based Injection Systems Mechanical Testing (JP13883) - Thousand Oaks, CA

Mon, 31 Mar 2025 16:11:42 GMT

Job Title: Engineer, Needle-Based Injection Systems Mechanical Testing (JP13883)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Design & Development ME
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 03/31/2025.
Notes: Only qualified candidates need apply. Hybrid. Must be local to Thousand Oaks, CA. Minimum 70% onsite after training period. 100% onsite for training in the beginning.

3Key Consulting is hiring! We are recruiting an Engineer - Needle-Based Injection Systems Mechanical Testing - for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application. (ISO 11608-1 Requirements and test methods for needle-based injection systems (NIS) for medical use. These systems are commonly used for the delivery of medicinal products, such as insulin pens, auto-injectors, and similar devices).

The Mechanical Engineer on the Combination Product Test Team will interact with global and cross-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include development, testing, transfer, and life cycle management of multiple autoinjector device commercialization efforts. Test activities will include Engineering, characterization and GMP verification testing and will require a strong proficiency in technical writing, reading comprehension, developing test protocols, statistical analysis, executing hands on testing, and reporting of results to senior leadership.

This position will work side by side with experienced Device Test Engineers authoring test protocols, executing test plans, performing data analysis, and finalizing test reports. The successful candidate will employ engineering skills and practices to gather user requirements and translate them into technical documentation for test execution and analysis. The position involves support of senior staff in the initiation, design, and delivery of projects milestones to support verification testing activities.

The chosen candidate will frequently spend time in a lab environment working with various types of testing equipment from manual measuring equipment through fully automated testing systems. The devices that will be tested include various iterations of handheld autoinjector drug delivery systems.

This role will include numerous collaboration sessions with the test team and global team to trade best practices, discuss issues and resolutions, and create a testing strategy. The chosen candidate may also take part in design and fabrication of test fixtures and processes.

Top Must Have Skill Sets:
•   Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies.
•   Experience working independently to execute test procedures and operate lab equipment (such as analytical balance, tensile tester, and other automated test equipment) while documenting results according to good documentation practices.
•   Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.
•   Nice to have: Background in statistical analysis.

Day to Day Responsibilities:
•   (50%) Hands on execution of test protocols in a lab environment, operating test equipment to collect data and record data according to good documentation practices. Testing of autoinjector devices, including the safe operation of test equipment
•   (35%) Technical authorship of test protocols and reports to support characterization and verification activities. Technical documentation (Test Plans/Protocols/Reports, Engineering Assessments, Design outputs, test-lab equipment/process/control)
•   (15%) Statistical data analysis of test results to be included in technical reports.

Basic Qualifications:
•   Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Preferred Qualifications:

Red Flags:
•   Candidates with Software or Electrical engineering these are NOT desired for the role.
•   No lab experience
•   Different industry (no experience of med device)
•   No mechanical or med device.
•   Spelling and grammatical errors in resume. Frequent short job durations and job hopping.

Why is the Position Open?
Supplement additional workload on team

Interview Process:
There will be between 1-2 panel interviews, then final interview with director.up interviews with Engineering staff. Once narrowed down, a final interview with Associate Director of the team.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Biopharma Upstream Process/Equipment Support (JP13874) - Thousand Oaks, CA

Fri, 28 Mar 2025 20:24:26 GMT

Job Title: Engineer, Biopharma Upstream Process/Equipment Support (JP13874)
Location: Thousand Oaks, Ca 91320
Employment Type: Contract
Pay Rate: $38.00 - $42.00/hour W2 with benefits
Business Unit: AMA Pilot Plant
Duration: 12 months with likely extensions and/or conversion to permanent
Posting Date: 03/28/25
Notes: Candidate will be required to be on site 3-4 days a week and may work remotely 1-2 days a week (activities permitting).

Must have biotech background/experience, plus must have cell culture/purification experience.

3 Key Consulting is hiring! We are looking for an engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The ideal candidate for the upstream engineer role is an early-career professional with a bachelor’s degree and 2 years of industry experience, or a recent master’s graduate, preferably in chemical engineering, biochemical engineering, or biology. They must have hands-on experience with mammalian cell culture (not fermentation), bioreactors, and upstream cell culture equipment, along with a strong biotech industry background. The candidate should be comfortable analyzing manufacturing data and presenting findings to cross-functional teams, including directors and large groups of manufacturing staff (20+). Strong communication and presentation skills are essential. While familiarity with downstream/purification processes is a plus, it is not required. Candidates must be able to work onsite 3–4 days per week in Thousand Oaks. Red flags include a pure chemistry background without relevant lab experience and weak communication abilities.

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Engineer will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.
Job Responsibilities:
Under guidance of senior staff, the Engineer performs the following:

Transfer cell culture and/or purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility
Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
Offer process validation support for late-stage commercial processes
Provide routine process monitoring and troubleshooting
Execute data trending and statistical process analysis
Support technical direction for process related deviations, CAPAs and change controls
Identify and support process related operational excellence opportunities
Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

PREFERRED QUALIFICATIONS:

Bachelor degree Chemical or Biochemical Engineering and 2 years of experience GMP Environment
1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
Background in biologics tech transfer into commercial facilities
Cell culture and/or Purification process knowledge:
Knowledge of purification processes/ equipment; scale up factors from chromatography, UF/DF, process deviations, raw materials to growth and quality attributes
Knowledge of cell culture processes/ equipment; scale up factors from, mass oxygen transfer capabilities impact of metabolism, process deviations, raw materials to growth and quality attributes
Strong capability of analysis, troubleshooting and problem solving
Ability to develop and follow detailed protocols
Independently motivated with ability to multi-task and work in teams
Excellent written and verbal communication skills with technical writing and presentation experience

Top Must Have Skills:

Specifically looking for upstream experience
Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Day to Day Responsibilities:
•   Ensure preventative maintenance is performed on equipment
•   Coordinate and organize project work
•   Support continuous improvement projects

Red Flags:

Education purely in chemistry without relevant biology/engineering experience
Experience only in downstream/purification without upstream relevance
Lack of communication skills
Inability to summarize technical data
Candidates not comfortable with onsite needs
Pure chemistry background without relevant bio/eng lab experience
Weak presentation abilities

Interview process:
Phone screen followed by in-person or video panel interviews.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Software Engineer, Senior - Biopharma, GMP Lab Instruments Automation (JP13852) - Thousand Oaks, CA

Tue, 25 Mar 2025 11:17:31 GMT

Job Title: Software Engineer, Senior - Biopharma, GMP Lab Instruments Automation (JP13852)
Location: Thousand Oaks, CA. 91320
Business Unit: Research & Automation Technologies
Employment Type: Contract
Duration: 3 years with possible conversion to FTE
Rate: $70 - $80/hour W2 DOE with benefits.
Posting Date: 3/25/2025
Notes: This is a 100% Onsite Position in Amgen's Thousand Oaks, CA. Candidates must be local (no relocation)

3 Key Consulting is hiring! We are recruiting a Senior Software Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
This role is office based, lab based, manufacturing floor. Candidate will be lab and office based. 50/50, working with lab instruments. Develop software to:
(1) control 3rd party and in-house, novel lab automation devices.
(2) automate data between lab automation and LIMS systems (e.g. Benchling) in close partnership with our infrastructure ecosystem team
(3) Manage DevOps infrastructure (GitLab, Team City, AWS).

Day to day responsibilities will be building lab scale solutions to help scientists accelerate the science they are executing. Using automation for data integration to control devices. EW will be rapidly going from one project to the next and need to be comfortable working in a fast-paced environment.

Ideal Candidate:

Experience working in automation
Must have good communication and people skills, will be regularly partnering with scientists in a collaborative way
Experience in Microsoft Dot Net Development, preferred language is C# (c-sharp), DevOps support consisting of GitLab, Team City, and AWS
Able to hit the ground running with this experience on the job.
At least BS degree in Computer Science and at least 4 years of work experience

Top Must Have Skill Sets:

Microsoft C#, WPF (Windows Presentation Foundation)
Visual Studio
AWS (Amazon Web Services)

Day to Day Responsibilities:
Flexible on-site/work from home software development, interaction with end-user scientists to understand their requirements and work through iterative sprints.

Basic Qualifications:
Doctorate Degree or Master Degree and 3 years of engineering experience or Bachelor Degree and 5 years of engineering experience or Associate degree and 10 years of engineering experience or high school diploma/GED and 12 years of engineering experience

Why is the Position Open?
Planned Project.

Red Flags:
Candidates without experience described in JD
Inability to speak in detail to experience listed on resume

Interview Process:
Phone screen and then ideally on-site interview.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Drug Delivery Devices/Development & Commercialization (JP13860) - Thousand Oaks, CA

Wed, 19 Mar 2025 18:37:16 GMT

Job Title: Engineer Senior, Drug Delivery Devices/Development & Commercialization (JP13860)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Prefilled Syringes & Kit Platform
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $45 - $50/hour W2 with benefits
Posting Date: 05/1/2025.
Notes: Only qualified candidates need apply. Onsite in Thousand Oaks, CA - 2-3 days per week onsite.

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.

The ideal candidate will have a B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal.
Nice to have: someone who has experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.

Top Must Have Skill Sets:
•   Pharma background.
•   Physical testing experience
•   Design controls experience

Day to Day Responsibilities:
•   Leading test procedure development and functional test execution
•   Leading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groups.
•   Authoring technical plans and reports
•   Performing advanced statistical data analysis
•   Supporting Leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team members.
•   Transfer of information to manufacturing sites, engagement with suppliers
•   Maintenance of Design History File content consistent with Good Documentation Practices
•   Training junior staff on physical test methods, sample preparation protocols and procedures, and effective report writing.
•   Reviewing primary data collected from peers in support for various design controls activities, including characterization and design verification.
•   Supporting design transfer activities by leading cross-functional coordination of sample procurement and testing.
•   Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.

Essential Skills:
•   Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
•   Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
•   Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
•   Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
•   System level root cause investigation; CAD/SolidWorks proficiency; tolerance analysis; capability analysis.
•   Coordinate and implement design improvements with development partners.
•   Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
•   Accountability of maintaining technical records within product design history files.
•   Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
•   Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).

Preferred Qualifications:
•   Degree in the field of Mechanical or Biomedical Engineering, or related field
•   Medical device industry and/or regulated work environment experience
•   Excellent written and verbal communication skills
•   Understanding and experience in:
o   Development/commercialization of medical devices and knowledge of manufacturing processes
o   Initiating and bringing complex projects to conclusion
o   Ability to work independently and dynamic cross functional teams
o   Design controls
o   Failure investigation
o   Applied statistics

Red Flags:
•   Poor communication skills
•   Lack of hands on testing experience

Why is the Position Open?
Planned Project

Interview Process:
One round of interviews.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Delivery Devices Testing & Analysis (JP13861) - Thousand Oaks, CA

Wed, 19 Mar 2025 18:18:02 GMT

Job Title: Engineer, Drug Delivery Devices Testing & Analysis (JP13861)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Pre-filled Syringes & Kit Platform
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 03/18/2025.
Notes: Only qualified candidates need apply. The candidate will need to have availability to go onsite any day of the week, M-F. Hybrid schedule will be 3-4 days per week for the first 2 quarters and then determined depending on business needs.

3 Key Consulting is hiring! We are recruiting an Engineer, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of client’s combination product portfolio.

Key responsibilities include:

•   Conducting hands-on experimental testing to support failure investigations and root cause analysis.
•   Developing, executing, and refining test procedures to evaluate device performance and functionality.
•   Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
•   Supporting design changes by leading testing efforts to assess and validate proposed modifications.
•   Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
•   Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
•   Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
•   Enhancing and expanding client’s delivery device platform as needed to meet evolving product and regulatory requirements.

The ideal candidate will:

•   Have strong laboratory testing experience, particularly with combination products and medical devices.
•   Possess a solid foundation in experimental methods and data analysis.
•   Be proficient in statistical tools and methodologies.
•   Demonstrate experience in failure analysis and implementing design solutions.
•   Have a proven ability to collaborate effectively within cross-functional teams.
•   Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
•   Show familiarity with regulatory and quality requirements for combination products and medical devices.
•   This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing client’s portfolio of drug delivery devices.

Top Must Have Skill Sets:
•   Problem solving (engineering skillset)
•   Organization (self-starter and project level management)
•   Communication (experience communicating at different levels and to different groups)

Day to Day Responsibilities:
•   Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
•   Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
•   Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
•   System level root cause investigation
•   Coordinate and implement design improvements with development partners.
•   Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
•   Accountability of maintaining technical records within product design history files.
•   Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
•   Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
Missing two or more of the following four items:
•   Degree in the field of Mechanical or Biomedical.
•   Medical device industry and/or regulated work environment experience.
•   Excellent written and verbal communication skill.
•   Understanding and experience in:
o   Development/commercialization of medical devices and knowledge of manufacturing processes
o   Initiating and bringing complex projects to conclusion
o   Ability to work independently and dynamic cross functional teams
o   Design controls
o   Failure investigation
o   Applied statistics

Additional stand-alone red flag: inability to be present on site/support ATO-site based activities. This is a hybrid role, NOT fully remote.

Why is the Position Open?
Planned Project

Interview Process:
Screening interview, followed by a panel interview. Following the panel interviews, if a tie-breaker is needed, there may be a 3rd final round to go in depth on specifics the team felt needed further discussion.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Validation Engineer, CSV Biopharma (JP13826) - New Albany, OH

Tue, 18 Mar 2025 15:33:55 GMT

Job Title: Validation Engineer, CSV Biopharma (JP13826)
Location: New Albany, OH. 43054
Business Unit: Ops Digital Technology Innovation
Employment Type: Contract
Duration: 6+ months with likely extension
Rate: $35-40/Hr on W2 with benefits
Posting Date: 3/18/2025
Target start date : 4/28/25
Notes: Onsite New Albany, OH - must be local. Standard hours.

3 Key Consulting is hiring! We are recruiting a CSV Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

The ideal candidate:
3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment. They must hold a Bachelor’s or master’s degree in computer science, Information Technology, Management Information Systems, Mechanical Engineering, or a related field, with a Master’s degree acceptable only if accompanied by at least 3 years of industry experience (no fresh graduates). The role requires onsite work with limited training time, so candidates must be able to hit the ground running. Overqualified candidates (e.g., PhDs or those with 15+ years of experience) may not be the best fit. Strong preference will be given to candidates from a pharmaceutical, biotechnology, or life sciences background.

Job Description:
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of client’s Ohio computer systems validation.

Top Must Have Skill Sets:

Experience with testing tools (ALM, or Kneat or ValGenesis).
Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management.
Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
Understanding of industry standards and best practices for computer system validation such as GAMP 5.
Must have experience with deviations
IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery)

Day to Day Responsibilities:

Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
Provide support on completion of validation deliverables as required per the project.
Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
Support regulatory inspections and internal audits as required.

Basic Qualifications:

Master degree OR Bachelor degree in Engineering and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
2. 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems).
Experience with ALM or Kneat testing tool is plus.
2. Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management.
3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
4. Understanding of industry standards and best practices for computer system validation such as GAMP 5.

Why is the Position Open?
Supplement additional workload on team.

Red Flags:

No experience on Computer system validation/ validation process.
No experience on Deviations.
Fresh graduates with no validation or industry experience.
Lack of experience with computer system validation or deviation management.
No background in Pharma, Biotech, Life Sciences, or relevant IT/Validation roles.
Candidates switching from unrelated industries (since training time is limited).
Overqualified candidates with 15-20+ years of experience and/or candidates with PhDs.

Interview Process:
WebEx or onsite.
Interview rounds: Typically 2 rounds (with hiring manager and his manager), but could extend to 3 rounds if needed

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Validation Engineer, CSV Biopharma (JP12934-R) - New Albany, OH

Tue, 18 Mar 2025 13:52:38 GMT

Job Title: Validation Engineer, CSV Biopharma (JP12934-R)
Location: New Albany, OH. 43054
Business Unit: Ops Digital Technology Innovation
Employment Type: Contract
Duration: 6+ months with likely extension
Rate: $35-40/Hr with benefits
Posting Date: 3/18/2025
Notes: Onsite New Albany, OH - must be local. Standard hours.

3 Key Consulting is hiring! We are recruiting a Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of client’s Ohio computer systems validation.

Top Must Have Skill Sets:

Experience with testing tools (ALM, or Kneat or ValGenesis).
Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management.
Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
Understanding of industry standards and best practices for computer system validation such as GAMP 5.
Must have experience with deviations
IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery)

Day to Day Responsibilities:

Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
Provide support on completion of validation deliverables as required per the project.
Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
Support regulatory inspections and internal audits as required.

Basic Qualifications:

Master degree OR Bachelor degree in Engineering and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
2. 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems).
Experience with ALM or Kneat testing tool is plus.
2. Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management.
3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
4. Understanding of industry standards and best practices for computer system validation such as GAMP 5.

Why is the Position Open?
Supplement additional workload on team.

Red Flags:

cannot support onsite operations
Overly long or irrelevant resume
Exaggerated or vague job titles and responsibilities
Lack of achievements or quantifiable results

Interview Process:
WebEx or onsite.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Product Fill/Finish Processing (JP13804) - Thousand Oaks, CA

Mon, 10 Mar 2025 15:07:54 GMT

Job Title: Engineer, Drug Product Fill/Finish Processing (JP13804)
Location: Thousand Oaks, CA. 91320 (hybrid)
Business Unit: Commercial Drug Product
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $36 - $41/hour W2
Posting Date: 03/10/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
We are seeking a skilled Engineer who can work independently to support technical projects. The ideal candidate will have expertise in drug product fill/finish processing, holistic drug product process knowledge, technical transfer, drug product manufacturing, and regulatory filings. Excellent communication skills and proficiency in technical writing are essential for this role.

Our ideal candidate will have 3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry. Open to previous job titles with more of a science background. (Ex: Scientist or Engineer previous titles). Key responsibilities include:

•   Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.
•   Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
•   Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
•   Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.
•   Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.
•   Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.
•   Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions.

Top Must Have Skill Sets:
•   Drug product fill/finish
•   Process development of drug product
•   Technical writing

Day to Day Responsibilities:
•   Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.
•   Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.
•   Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.
•   Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.

Basic Qualifications:
•   Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Preferred Qualifications:
•   Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or a related field.
•   3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
•   Knowledge of and hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.
•   Experience with unit operations for parenteral manufacturing (e.g., filling, filtration, mixing), specifically lyophilization, is an advantage.
•   Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
•   Knowledge of protein biochemistry with regard to chemical and physical stability.
•   Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
•   Strong knowledge of drug product manufacturing.
•   Demonstrated ability to work effectively in cross-functional teams to advance complex projects to completion.

Red Flags:
•   Someone who has many jobs in the last year. Someone who is not local.
•   Overqualified - 10+ years of experience
•   Underqualified - Less than 3 years of experience with only a B.S

Why is the Position Open?
Supplement to the teams workload.

Interview Process:
•   Phase 1, initial interview with hiring manager.
•   Phase 2 interview with team and senior management.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Automation Engineer Principal (DeltaV/PLC/Scada), Biopharma/GMP - (JP13780) - Thousand Oaks, CA

Thu, 27 Feb 2025 10:09:48 GMT

Job Title: Automation Engineer Principal (DeltaV/PLC/Scada), Biopharma/GMP - (JP13780)
Location: Thousand Oaks, CA. 91320
Business Unit: Advanced Technology & Automation
Employment Type: Contract
Duration: 2+ years with possible conversion to FTE
Rate: $50 - $70/hour W2 DOE with benefits, open to less Senior as well.
Posting Date: 2/27/2025
Target start date: 3/23/2025

3 Key Consulting is hiring! We are recruiting an Automation Engineer Principal for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
We are seeking a professional Principal Automation Engineer for a long-term contracting opportunity with our client, a global leader in the biotech industry, as a member of the Manufacturing & Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team.

The successful candidate will be required to support Clinical & Commercial Plant Automation Programs and Capital Projects for the EPO Manufacturing team, including complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and operational excellence. This position requires an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies. This role is expected to deliver on assigned capital projects and drive accountability.

Top Must Have Skill Sets:

Life science experience
Rockwell Automation Experience
GMP Manufacturing facility experience
Onsite position
3-5 years industry experience

Day to Day Responsibilities:

Manage day-to-day support of ATO Drug substance operations
Represent plant automation team in Area WCTs
Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including External Workers (EWs), onboarding the EWs, and ensuring the direct reports’ adherence to client training requirements.
Represent Plant Automation team during the development of project plan, business case, and cost estimates in partnership with key customers and stakeholders – ATO MCS Plant Operations, Engineering, Operations Information Systems (OIS), Global Construction Project Management (GCPM), and provide necessary support to obtain funding approval.
Based on project scope, work with OIS to estimate manhours and required resources
Represent Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with Engineering and GCPM.
Represent Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
Represent Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and Client CMDB systems.
Ensure compliance to Client Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
Represent Plant Automation team and support functional area projects focused on improving process equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug substance and drug product manufacturing technologies into clinical/commercial facility.
As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
12) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

Basic Qualifications:
Doctorate degree and 2 years of experience or Master degree and 6 years of experience or Bachelor degree and 8 years of experience.

Preferred Qualifications:

Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product and Supply chain plant operations.
Has five or more years combined experience with the following automation systems:
- Emerson Delta-V DCS system.
- Rockwell Automation SCADA and PLC Platform.
- ABB Robot and Mitsubishi roller bottle machine
- Emerson Delta-V DCS system.
- Electronic Batch Reporting Systems Design and implementation experience.
- Process Control Network design including network segregation.
- Process Control Systems: Virtual Infrastructure design and implementation.
- System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
- Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.
Proficient in project management skills.
Ability to influence and motivate others outside of direct line of authority.
Strong ability to interface effectively with all levels.
Effective meeting management.
Quick learner; proactive; takes initiative.
Results oriented and goal driven.
Ability to organize, interpret, communicate, and/or present information.
Proficient facilitation, negotiation, problem-solving, and conflict resolution skills.
Strong oral and written communication skills.
Demonstrates willingness to put in extra effort when necessary to pursue tasks and conclusion.

Why is the Position Open?
Planned Project.

Red Flags:

Lack of GMP Experience
Lack of Automation background

Interview Process:
Technical Round, Management round.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Prefilled Syringe Design and Test (JP13742) - Thousand Oaks, CA

Wed, 26 Feb 2025 10:30:16 GMT

Job Title: Engineer, Prefilled Syringe Design and Test (JP13742)
Location: Thousand Oaks, CA. 91320
Business Unit: Prefilled Syringes & Lyo Kit Platforms
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $36 - $41/hour W2
Posting Date: 02/26/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Engineer, Prefilled Syringe Design and Test for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Device Engineer will participate in the design, development, and lifecycle management of design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.

Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.

Top Must Have Skill Sets:
•   Hands on Laboratory Experience in a GLP Setting (Science or Engineering Lab)
•   GMP and GDP Technical Writing Skills
•   CAD experience or knowledge (such as Solidworks)

Day to Day Responsibilities:
The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space. The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP and GDP standards. Laboratory testing will primarily include the use of an Instron force tester and vision systems. The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. Fill-Finish experience is a bonus but not mandatory.

Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.

•   Adheres to strict documentation practices in a GMP regulated environment
•   Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
•   Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
•   Authors and reviews technical documentation including protocols, reports, and technical assessments
•   Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
•   Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
•   Maintains device and combination product design history files for assigned products
•   Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
•   Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
•   Provide general laboratory support including inventory management, sample shipments, and cleanup.
•   Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Preferred Qualifications:
•   Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
•   Understanding of Mechanical Design Engineering Concepts
•   Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
•   Experience with design controls; including (but not limited to) design verification and transfer
•   Understanding of risk assessments including hazard and probability analysis
•   Experience with investigations and quality records
•   Laboratory and electronic lab notebook experience
•   Statistical Analysis software (Minitab or JMP)
•   Experience with Instron force testers using BlueHill Universal
•   Test method development, GR&R, and text fixture design
•   Ability to work independently and dynamically across functional teams
•   Strong technical writing and verbal communication skills including technical presentations (i.e., PowerPoint)
•   Ability to support complex workstreams under demanding timeline
•   Understanding of the following standards and regulations: Quality System Regulation – 21CFR820; Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices – ISO 14971; EU Medical Device Regulation – 2017/745

Red Flags:
•   No GxP laboratory experience
•   2. No GDP experience
•   3. Only academic technical writing experience (non-industry setting)

Why is the Position Open?
Backfill

Interview Process:
•   Virtual 1 on 1 interview with hiring manager
•   Virtual 1 on 1 interview with organization department manager
•   Panel interview (2-3 colleagues)

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Mechanical Engineering Methods Combination Products- Hybrid (JP13738) - Thousand Oaks, CA

Tue, 25 Feb 2025 14:36:49 GMT

Job Title: Engineer, Mechanical Engineering Methods Combination Products- Hybrid (JP13738)
Location: Thousand Oaks, CA. 91320 (hybrid)
Business Unit: Physical Testing Systems Development
Employment Type: Contract
Duration: 18+ months with likely extensions and/or conversion to a permanent position.
Rate: $37- $41/hour W2
Posting Date: 02/25/2025.
Notes: Only qualified candidates need apply. 2 days a week onsite minimum - Tuesdays & Thursdays may differ as needed

3 Key Consulting is hiring! We are recruiting an Engineer, Mechanical Engineering Methods Combination Products for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Ideal Candidate: B.S. and 2 years of experience. Solid works, statistical analysis, and technical writing.

The Engineer, in Final Product Technologies- Mechanical Engineering Methods, is responsible for engineering activities required for the development, qualification, validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.

Top Must Have Skill Sets:
•   Solid works Experience
•   Technical Writing Skills
•   Statistics Experience

Day to Day Responsibilities:
•   Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
•   Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
•   Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
•   Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
•   Coordinate test method development and delivery with selected contractors.
•   Ensure that qualification parameters are met for product assembly requirements.
•   Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
•   Generate procedures necessary to support department and new process equipment.
•   Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design.
•   Perform other duties as required by the Group Manager.
•   Comply with the requirements, responsibilities, and authority as required.
•   Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project goals.
•   Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects.
•   Networks with manufacturing, quality and regulatory organizations both internal and external to client.
•   Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle.
•   Excellent verbal and written communication skills are utilized to communicate project status and risks associated with integrated timelines to leadership.
•   Collaborates with other functional leaders to ensure project success, momentum and commitment.
•   Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently.
•   Integrates partner/vendor timelines with client timelines as appropriate, software, systems, and methods.

Basic Qualifications:
Master's Degree
OR Bachelor's Degree and 2 years of engineering/scientific experience
OR Associate's degree and 6 years of engineering/scientific experience
OR High school diploma/GED and 8 years of engineering/scientific experience.

Preferred Qualifications:
•   M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
•   Excellent written and verbal communication skills
•   Ability to work in a highly matrixed team environment
•   2 years of experience in the biotechnology/pharmaceutical industry
•   2 years of experience in equipment, method, and mechanical design
•   Technical writing experience
•   Experience with SolidWorks (or other 3D-CAD software)
•   Experience with combination products and regulatory requirements
•   Experience utilizing Minitab (or other statistical software packages)

Red Flags:
No Solid works Experience, No Technical Writing Skills, No Statistics Experience, Large gaps in employment, No validation or qualification experience, must be able to manage multiple projects, lacking communication skills, and must be willing to be on site in Thousand Oaks when needed.

Why is the Position Open?
Planned Project.

Interview Process:
30 minute Phone Interview with Reporting Manager; 1 Hour In-Person Panel Interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Drug Development Process Improvement (JP13693) - Cambridge, MA

Tue, 25 Feb 2025 14:03:55 GMT

Job Title: Associate Engineer, Drug Development Process Improvement (JP13693)
Location: Cambridge, MA. 02138
Business Unit: DST Synthetics B
Employment Type: Contract
Duration: 2+ year with likely extensions and/or conversion to a permanent position.
Rate: $30 - $35/hour W2
Posting Date: 02/25/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
As the DST representative you will be responsible to collaborate with the product delivery team(s) to work with the manufacturing organization(s) to ensure drug substance supply and resolve challenges, identifying and implementing process improvements, and authoring regulatory documents in support of the product lifecycle works with a multi-functional group of engineers and scientists through the process development cycle at client to ensure our process requirements and knowledge are suitable for its intended phase of technology transfer: process introduction, clinical manufacturing, validation and commercial manufacturing. Partners with our manufacturing teams to assess the equipment and manufacturing operations meet process requirements, where necessary work with the sites(s) to introduce processes that deliver meaningful therapeutics for our patients.

Top Must Have Skill Sets:
•   Academic background in Chemical Engineering with strong knowledge in engineering principles and/or organic chemistry with basic understanding of cGMP/GLP requirements.
•   Knowledge of analytical techniques and solid-state characterization and familiarity with statistical analysis and working knowledge of standard plant operations and safety practices
•   Excellent project management skills, Strong verbal communication and presentation skills
•   Willing to be hybrid as needed.

Day to Day Responsibilities:
•   Critically evaluate new processes for identification of process improvements and requirements necessary to prepare processes for scale up and tech transfer.
•   Use, refine and develop models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.
•   Analyze and document the economic value of existing, proposed process solutions and new process concepts.
•   Apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.
•   Routinely monitor manufacturing processes for performance indicators and operations.
•   Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer.
•   Author, review and/or approve of process documentation needed for process validation and commercialization.
•   Provide support to commercial projects to support supply demand, ensure highest quality standards and guarantee patient safety.
•   Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis, unit operations and life cycle phase of commercial products.

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Why is the Position Open?
Backfill

Interview Process:
Phone Screen followed by Phone interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Biopharma Process Development – Onsite/Hybrid (JP13727) - Thousand Oaks, CA

Thu, 20 Feb 2025 15:09:45 GMT

Job Title: Engineer, Biopharma Process Development – Onsite/Hybrid (JP13727)
Location: Thousand Oaks, Ca.
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 12 months with possible extension of conversion to FTE
Posting Date: 02/20/2025
Rate: $36-41/Hr on W2 with benefits
Note: Must be local to Thousand Oaks. Staff should be a Flexible Commuter. - About 2-3 days per week onsite.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Ideal Candidate:
The ideal candidate for this role should have a bachelor’s degree in any engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. They should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills. This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop over time.

Job Description:
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to various aseptic fill finish manufacturing plants and production lines.

The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of company products. The candidate will assist in establishing the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Qualifications

Master’s degree OR Bachelor's Degree and 2 years of relevant experience
Preferred Qualifications/Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology correlated technical field of study in biotechnology, life sciences or related discipline.
Knowledge in scientific principles of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
Ability to work on multiple projects simultaneously, learn new techniques, keep accurate records, follow SOP’s and instructions in compliance with company policies, and comfortable to operate in a very flexible, agile environment
Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports.
Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with some oversight
Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
Demonstrated ability to use interpersonal skills to build strong technical relationships.
Self-motivation, adaptability, and a positive attitude.
Excellent communication skills, both oral and written.

Why is the Position Open?
Supplement to the teams workload

Top Must-Have Skill Sets:

Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude

Day to Day Responsibilities:
Responsibilities include, but are not limited to, the following:

Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
Support development and maintenance of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
Development of digital tools and models by leveraging data analytics and programming skills
Support at scale characterization and/or process validation runs as person in plant

Red Flags:

Not being team player
Not have B.S. in Science/Engineering
Fresh out of college.

Interview process:
1. 1:1 Interview With Hiring Manger
2. 1:1 Interview with Director Level

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Test Method/Studies Development (JP13694) - Thousand Oaks, CA

Tue, 18 Feb 2025 11:53:43 GMT

Job Title: Engineer, Test Method/Studies Development (JP13694)
Location: Thousand Oaks, CA. 91320
Business Unit: Physical Testing Systems Development
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $37 - $41/hour W2
Posting Date: 02/18/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Engineer, Test Methods/Studies Development for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects. Employ engineering skills and practices to gather product / device performance requirements and translate them into test procedures:
•   Develop fixturing and/or equipment to perform testing
•   Create test procedures to test product / device requirements
•   Validate the suitability and performance through engineering studies
•   Qualify/Validate the performance of Commercial Off the Shelf (COTS) systems

Top Must Have Skill Sets:
•   Technical Writing / Documentation
•   Engineering (Mechanical or Biomedical preferred)
•   Basic Statistics
•   CAD skills (Solid Works etc.)

Day to Day Responsibilities:
Method Validation:
•   Meet with stakeholders to gather user needs, test parameters and requirements
•   Create and review test procedures, data, and reports.
•   Develop test studies using existing methodologies to assess method performance
•   Perform testing to support method performance

Equipment Qualification and Lifecycle Support
•   Create qualification documentation
•   Perform test procedures to support equipment qualification
•   Implement process improvements, and develop technical changes as needed.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
•   Mechanical engineering / CAD
•   Statistics (Basic Statistics, GR&R, ANOVA, Comparability)
•   Technical Writing

Red Flags:
Frequent job changes (multiple 1 year experiences)

Interview Process:
•   One 30 minute interview (virtual)
•   Two 45 minute panel interviews (virtual or in-person) 3-5 people may be included on the panel interviews

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer - Biopharma Upstream/Downstream Process/Equipment Support (JP13711) - Cambridge, MA

Mon, 17 Feb 2025 13:36:00 GMT

Job Title: Engineer - Biopharma Upstream/Downstream Process/Equipment Support (JP13711)
Location: Cambridge, MA. 02138
Employment Type: Contract
Pay Rate: $37.00 - $41.00/hour
Business Unit: AMA Pilot Plant
Duration: 9+ months (with likely extensions and/or conversion to permanent)
Posting Date: 02/17/25
Notes: Only qualified candidates need apply. * * * Manager is not interested in relocation candidates.

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our client is seeking an Engineer at its Cambridge, MA site to provide equipment support. Our ideal candidate will have:
•   Previous biotech/pharma experience (would be a plus)
•   Experience working with equipment
•   B.S. in a scientific field
•   Manager is open to entry level candidates.
•   Upstream cell culture or downstream purification experience (nice to have)
•   Chemical Engineering B.S preferred
•   Nice to have: instrumentation background, preventative maintenance, automation background (DeltaV or Finesse controllers), and process monitoring or trending experience. Bioreactors, Chromatography

Responsibilities include:
•   Perform the system owner role for assigned systems to ensure equipment reliability and technology development initiatives.
•   Develop and maintain process control automation solution for bench top Finesse and DeltaV Controllers systems in Next Generation Lab
•   Coordinating projects for equipment modification/improvement
•   Data trend analysis of the system and equipment used for technology development to identify and proactively manage performance trends.
•   Ensuring the preventive maintenance schedule for the systems is successfully implemented.
•   Create a critical spare parts list for the systems/equipment and maintain appropriate levels of spares.
•   Troubleshooting of performance trends and equipment reliability.
•   Support of new product introductions and implementation of new equipment/technology.
•   Support of continuous improvement project monitoring effectiveness of implemented projects.
•   Initiating review and approval of changes to operating procedures and EHS change control process relating to the system.
•   Identify and implement engineering-based improvements or upgrades to process equipment, including identification of design requirements, options analysis, design, installation, startup and qualification of equipment.
•   Designing, executing, implementing and leading engineering or process projects
•   Working in a collaborative manner with various functions and contributing to investigations

Why is the Position Open?
Supplement to the team’s workload.

Top Must Have Skills:
•   Organized project work
•   Proactive troubleshooting
•   Collaborative project experience

Day to Day Responsibilities:
•   Ensure preventative maintenance is performed on equipment
•   Coordinate and organize project work
•   Support continuous improvement projects

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
•   Low GPA. Non-scientific major / experience.
•   Candidates must be willing to grow and develop.
•   Job hopping.

Interview process:
Phone screen followed by in-person or video panel interviews.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Biotech Sterilization (JP13707) - Cambridge, MA

Mon, 17 Feb 2025 11:23:04 GMT

Job Title: Engineer Senior, Biotech Sterilization (JP13707)
Location: Cambridge, MA. 02138
Business Unit: Manufacturing Science and Technology
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $50/hour W2
Posting Date: 02/17/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Gas Sterilization for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Senior Engineer works as part of a multi-disciplinary program team to build drug delivery solutions which meet user requirements for client’s portfolio of therapeutic products from concept through commercial entry. The individual advances technical programs, contributing to definition of design requirements, identification and realization of technical solutions, authoring of test methods and reports, and authoring of technical analyses to advance programs. The successful candidate establishes well-supported insights for development, clinical and commercial stage solutions to serve user needs and the needs of the pipeline portfolio, using a range of program tools, design characterization and verification methods, and design reviews. S/he ensures that the required performance and quality targets are satisfied and helps identify and reduce technical risks on the program.

Top Must Have Skill Sets:
•   Sterilization experience
•   Qualification/ quality experience
•   Commercial process lifecycle management

Ideally looking for someone locally but open to someone who will relocate with the proper and strong sterilization experience

Day to Day Responsibilities:
•   support/ lead process development and commercialization of gas sterilization processes of combination products
•   coordinate/ lead manufacturing site requirements to support sterilization requirements
•   support the design control process and qualification of primary components
•   support/ lead tech transfer projects for combination products
•   support/ lead the development and operational improvements with key primary component suppliers
•   support development of characterization methods for mechanical and physical properties of primary components
•   support on-going deviation/ CAPA and change control
•   support/ lead client’s supplier/ raw materials sterility assurance assessments
•   collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
•   drive and influence key opinion leaders by providing technical papers, presentations and attending key conferences

Basic Qualifications:
•   Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
•   3+ years in ethylene oxide or other gas sterilization processes
•   3+ years industry experience in sterility assurance of combination products
•   3+ years in ethylene oxide, moist heat, and/ or vaporized hydrogen peroxide sterilization
•   Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
•   Strong problem-solving skills
•   Capability to advance multiple projects in a fast paced environment
•   Strong oral and written communication skills, decision making, presentation, and organization skills
•   Basic Qualifications

Interview Process:
Phone and In Person

Why is the Position Open?
Supplement additional workload on team

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Biotech Combination Products - Hybrid (JP13709) - Thousand Oaks, CA

Tue, 11 Feb 2025 12:50:14 GMT

Job Title: Engineer Senior, Biotech Combination Products - Hybrid (JP13709)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Prefilled Syringes - New Product Development
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $48/hour W2 with benefits
Posting Date: 2/11/2025.
Notes: Onsite Thousand Oaks, CA - 2-3 days per week onsite

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Combination Products for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
B.S. and a minimum of 3+ strong years of experience. 5 YOE is ideal.
Experience working on prefilled syringes or vials. Combination product experience. Regulatory experience.

The Device Engineer will participate in the medical device/combination product design, development, and commercialization activities for drug delivery devices, focusing on prefilled syringes.

Key responsibilities include:

Leading test procedure development and functional test execution
Leading material inventory management for prefilled syringe programs, including material forecasting and material custody across multiple sites and functional groups.
Authoring technical plans and reports
Performing advanced statistical data analysis
Supporting Leading technical assessments and root cause investigations as well as planning and delegation of sub-tasks to other team members.
Transfer of information to manufacturing sites, engagement with suppliers
Maintenance of Design History File content consistent with Good Documentation Practices
Training junior staff on physical test methods, sample preparation protocols and procedures, and effective report writing.
Reviewing primary data collected from peers in support for various design controls activities, including characterization and design verification.
Supporting design transfer activities by leading cross-functional coordination of sample procurement and testing.
Supporting the setting of specification limits for platform devices through human factors studies benchtop testing.

Essential Skills:

Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
System level root cause investigation; CAD/SolidWorks proficiency; tolerance analysis; capability analysis.
Coordinate and implement design improvements with development partners.
Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
Accountability of maintaining technical records within product design history files.
Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).

Preferred Qualifications:

Degree in the field of Mechanical or Biomedical Engineering, or related field
Medical device industry and/or regulated work environment experience
Excellent written and verbal communication skill
Understanding and experience in:
Development/commercialization of medical devices and knowledge of manufacturing processes
Initiating and bringing complex projects to conclusion
Ability to work independently and dynamic cross functional teams
Design controls
Failure investigation
Applied statistics

Top Must Have Skill Sets:

Pharma background.
Physical testing experience
Design controls experience

Red Flags:
Poor communication skills
Lack of hands on testing experience

Why is the Position Open?
Supplement to current team

Interview Process:
One rounds of interviews

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Measurement and Test Method Validation (JP13658) - Thousand Oaks, CA

Wed, 05 Feb 2025 17:34:11 GMT

Job Title: Engineer, Measurement and Test Method Validation (JP13658)
Location: Thousand Oaks, CA. 91320
Business Unit: MEM Test Automation
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $36 - $41/hour W2
Posting Date: 02/05/2025.
Notes: Only qualified candidates need apply. Onsite. candidates must be within a commutable distance

3 Key Consulting is hiring! We are recruiting an Engineer, Measurement and Test Method Validation for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The ideal candidate for this Test Method Validation Engineering role will have:
•   Bachelor’s degree in Engineering (Mechanical Engineering preferred)
•   2+ years of industry experience (internship experience is acceptable).
•   Solid understanding of measurement concepts and engineering measurements
•   Basic knowledge of statistics, including confidence intervals and statistical analysis tools.
•   Either direct experience in test method validation or strong analytical skills and the ability to learn quickly will be considered.
•   Experience in regulated industries such as pharmaceuticals, medical devices, or other compliance-driven environments will have an advantage, as 70% of the role involves documentation and regulatory compliance.
•   RQPQ (Risk, Qualification, Process Qualification)
•   Installation Qualification (IQ) Operational Qualification (OQ, PQ) is beneficial but can be developed on the job.
•   Strong problem-solving skills, adaptability, and a demonstrated ability to work in a highly regulated and collaborative environment are key for success in this role.

Test Method and Validation Engineer Position. This position involves support of senior staff in design, development, modification, qualification, validation, and transfer of the test methods for drug delivery combination products and their subassemblies, including drug product containers and packaging components. The particular focus would be on automated dimensional measurements methods, advanced methods for measuring functional attributes of injection systems and enhancing the visual inspection methods.

Candidates are expected to have basic engineering skills with a bachelor’s degree in engineering from an accredited university. They are also expected to have strong technical writing skills and be familiar with different engineering measurement techniques and equipment.

Candidates having a master’s degree in mechanical or electrical engineering with the following skills are preferred:
•   Statistical analysis
•   Gage R&R
•   Optical and automated measurement devices
•   Test method development
•   CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ.
•   Teamworking and communication skills is required for this position.

Top Must Have Skill Sets:
•   Bachelor’s degree in an engineering field
•   Technical writing
•   Engineering measurement

Day to Day Responsibilities:
•   Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
•   Creating new test methods and the required test fixtures.
•   Creating a qualification, validation and transfer plan for the test methods, when required.
•   Performing and operating the tests required for qualification, validation and transfer of the methods.
•   Creating training documents.
•   Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Preferred Qualifications:
•   Statistical analysis
•   Gage R&R
•   Optical and automated measurement devices
•   Test method development
•   CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ.
•   Teamworking and communication skills is required for this position.

Red Flags:
•   Candidate without Statistical Understanding.
•   Candidates without general measurement knowledge.

Why is the Position Open?
Supplement additional workload on team

Interview Process:
Phone screening interview by hiring manager, then two panel interview for selected candidates.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Mechanical Device Laboratory Design and Testing Lifecycle (JP13662) - Thousand Oaks, CA

Wed, 05 Feb 2025 15:08:49 GMT

Job Title: Engineer, Mechanical Device Laboratory Design and Testing (JP13662)
Location: Thousand Oaks, Ca.
Business Unit: Prefilled Syringes And Lyo Kit Platforms
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $36-41/hours W2 with benefits
Posting Date: 2/5/2025
Target Start Date: 3/3/2025

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: Excellent communication, force testing experience, design verification testing (design controls), understanding of mechanical systems and design, proficiency with MS suite. Bachelors in relevant engineering or any scientific field as long as they have hands on Laboratory Experience in a GxP Setting (Science or Engineering Lab). Willing to consider those with relevant internship experience.

Job Description:
The Device Engineer will participate in the design, development, and lifecycle management of design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.

Scope includes mechanical delivery devices, such as Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.

Essential skills and Responsibilities:

Adheres to strict documentation practices in a GMP regulated environment
Engineering competency in all conventional aspects of the subject matter, functional area, and assignments
Plans and performs work, independently evaluating, selecting, and adapting standard methods, and creating new solutions to engineering problems.
Authors and reviews technical documentation including protocols, reports, and technical assessments
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
Maintains device and combination product design history files for assigned products
Ensure test methods and test protocols are developed in a sound and robust framework with high focus on eliminating test errors
Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
Provide general laboratory support including inventory management, sample shipments, and cleanup.
Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications

Preferred Qualifications:

Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
Understanding of Mechanical Design Engineering Concepts
Experience with Final Drug Product and/or Drug Product, medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
Experience with design controls; including (but not limited to) design verification and transfer
Understanding of risk assessments including hazard and probability analysis
Experience with investigations and quality records
Laboratory and electronic lab notebook experience
Statistical Analysis software (Minitab or JMP)
Experience with Instron force testers using BlueHill Universal
Test method development, GR&R, and text fixture design
Ability to work independently and dynamically across functional teams
Strong technical writing and verbal communication skills including technical presentations (i.e., PowerPoint)
Ability to support complex workstreams under demanding timeline
Understanding of the following standards and regulations: Quality System Regulation – 21CFR820; Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices – ISO 14971; EU Medical Device Regulation – 2017/745

Top Must Have Skill Sets:

Hands on Laboratory Experience (Science or Engineering Lab)
Good Communication and Technical Writing Skills
Ability to Multitask Complex Workstreams

Day to Day Responsibilities:
The device engineer will support a team of engineers on a variety of projects related to laboratory testing, device life cycle management, and product-based initiatives regarding prefilled syringes in both commercial and developmental space. The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards. Laboratory testing will primarily include the use of an Instron force tester and vision system. The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material. Fill-Finish experience is a bonus but not mandatory.
Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Employee Value Proposition

Unique industry opportunity
Networking
Career growth

Red Flags:
1. Remote work only
2. No previous industry or laboratory experience
3. Unfamiliar with Good Documentation Practices
4. Poor communication
5. No to little technical writing experience

Interview Process:
Panel Interview – MS Teams

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

EHS Specialist, Biopharma (JP13660) - Thousand Oaks, CA

Tue, 04 Feb 2025 18:20:37 GMT

Job Title: EHS Specialist, Biopharma (JP13660)
Location: Thousand Oaks, CA. 91320
Business Unit: E EHS R&D & PD
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $50 - $58/hour W2 with benefits
Posting Date: 02/04/2025.
Notes: Only qualified candidates need apply. * * *Must have industrial safety experience. Looking for local candidates only.

3 Key Consulting is hiring! We are recruiting an EHS Specialist for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have:
•   Industrial safety/contractor safety experience
•   OSHA safety experience (or OSHA 8-hour class)
•   Risk assessments & job hazard assessments
•   Knowledge of chemical and biological manufacturing
•   Familiarity with organizational safety programs
•   2-3+ years of experience, preferably in pharmaceutical/biotech environments
•   Bachelor’s degree
•   Good communication skills, clear message, self-sufficient
•   Degree in Occupational Safety (e.g., from CSUN)
•   Experience with risk management and regulatory compliance
•   Strong leadership skills.
•   Strong understanding of safety principles and a proven track record in maturing programs and processes.
•   The position requires the ability to collaborate cross functionally and to influence management across many functions.

We are looking for an experienced professional in the Environment, Health and Safety (EHS) group to lead safety and health programs at our client’s Thousand Oaks location. The successful candidate will:
•   Be responsible for the continuous improvement of safety programs across the client’s Thousand Oaks campus.
•   Assist in developing and implementing a safety and health strategy across the client’s Thousand Oaks campus
•   Have a strong understanding of EHS disciplines and be able to support clients with input from other EHS and site subject matter experts.
•   Provide expert level assessment support across the campus

Primary responsibilities include:
•   Assisting with development, advancement and implementation of the safety and health programs and strategy across the Thousand Oaks campus
•   Advancing core safety and health programs to manage EHS risks including, but not limited to, contractor and industrial safety, environmental compliance, process safety and industrial hygiene.

Top Must Have Skill Sets:
•   Experience in managing OSHA Safety Programs
•   Experience in Risk Management
•   Organizational Skills

Day to Day Responsibilities:
•   Walk from building to building and interact with clients.
•   Review equipment change controls.
•   Complete accident investigations.

Basic Qualifications:
•   EHS bachelor’s degree and 3 years of experience in EHS supporting safety and health programs
•   Knowledgeable in chemical and biological manufacturing and laboratory operations
•   Familiar with the hierarchy of controls, Safety Data Sheets, and monitoring equipment
•   Strong leadership and team building skills
•   Process driven and action-oriented, with a strong Operational Excellence mindset
•   Self-starting with program development and project management experience
•   Effective oral and written communication and presentation skills
•   Strong technical writing skills
•   Proficient in Microsoft Office and other computer software systems

Preferred Qualifications:
•   5 years of experience in the pharmaceutical/biotech industry leading industrial programs
•   Experience implementing and supporting safety and health programs
•   Proficient in conducting risk assessments and developing sampling strategies
•   Demonstrated ability to lead diverse teams and influence management
•   Strong verbal & written communication skills, ability to effectively communicate cross functionally

Red Flags:
•   Candidates not willing to work onsite at least 3 days a week (could be 5)
•   Candidates with no prior industrial safety experience (e.g., someone who was only a department safety rep)
•   Relocation Candidates
•   Overqualification: Candidates with more than 6 years of experience

Interview Process:
Phone interview followed by onsite interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Life Cycle Management GMP Test Methods – Combination Products (JP13635) - Thousand Oaks, CA

Thu, 30 Jan 2025 14:10:50 GMT

Job Title: Engineer, Life Cycle Management GMP Test Methods – Combination Products (JP13635)
Location: Thousand Oaks, CA. 91320 (hybrid)
Business Unit: Mechanical Design Engineering
Employment Type: Contract
Duration: 2+ years with likely extensions and/or conversion to a permanent position.
Rate: $36 - $41/hour W2
Posting Date: 1/30/2025.
Notes: Only qualified candidates need apply. This is a hybrid role aligned to client's Thousand Oaks, California location, local candidates only

3 Key Consulting is hiring! We are recruiting an Engineer Life Cycle GMP Test Methods – Combination Products for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods.

The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.

The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions. This may include, but is not limited to, the following:
•   Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
•   Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT), IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
•   Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
•   Developing, enhancing, automating, and managing test data
•   Network with manufacturing and quality organizations internal to client
•   Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
•   Monitoring technological developments in the field & evaluation of new technologies

Top Must Have Skill Sets:
•   Statistical analysis, and knowledge of Gage R&R,
•   Knowledge of Optical measurement devices, force testers, BLE testing
•   Test method development, CAD design, Solidworks, mechanical modeling

Day to Day Responsibilities:
•   Support FTE Engineers developing Methods and performing testing
•   Create and revise documentations

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Preferred Qualifications:
•   Experience working in a regulated industry, exposure to GMPs
•   Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
•   Statistical analysis, and knowledge of Gage R&R,
•   Knowledge of Optical measurement devices, force testers, BLE testing
•   Test method development, CAD design, Solidworks, mechanical modeling
•   Manufacturing experience, IQ, OQ, and PQ
•   Passion for proactively identifying opportunities through creative data analysis and modeling
•   Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
•   Ability to manage multiple, competing priorities simultaneously, experience with MS Project, Smartsheet

Red Flags:
Zero experience with combination products, but we are willing to consider training a junior engineer.

Interview Process:
Phone screening with hiring manager, followed by final panel interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Sr. Engineer – Biotech Environment & Sustainability – Remote (JP13584) - Thousand Oaks, CA

Tue, 28 Jan 2025 17:26:58 GMT

Job Title: Sr. Engineer – Biotech Environment & Sustainability – Remote (JP13584)
Location: Thousand Oaks, Ca. (Remote work)
Business Unit: Environment & Sustainability
Employment Type: Contract
Duration: 6 months with possible extension
Rate: 40-50$/hours W2 DOE with benefits
Posting Date: 1/28/2025
Target Start Date: 2/10/2025

3 Key Consulting is hiring! We are recruiting a Sr. Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate:
The ideal candidate will have a strong background in lifecycle analysis, data inventory gathering, and managing large datasets. Key responsibilities include working with internal and external suppliers, leveraging programming languages such as R and Python, and delivering compelling presentations supported by strong data visualization skills.

Preferred educational background in Environmental Science from UCSB or Duke University.

Technical Skills:
Expertise in lifecycle analysis.
Proven ability to gather and manage inventory data from various sources.
Proficiency in programming languages such as R and Python.
Strong data visualization and presentation skills.

About the Role
As a member of the Environmental Sustainability team, you will play a pivotal role in developing and expanding the Life Cycle Assessment (LCA) library. This role involves creating robust LCA frameworks, gathering and analyzing life cycle inventory (LCI) data, and ensuring compliance with national and international standards. You will contribute directly to advancing environmental transparency and sustainability in the pharmaceutical sector.

Key Responsibilities

LCA Development:
Design and expand Life Cycle Assessment (LCA) methodologies tailored to the pharmaceutical industry. Integrate emerging life cycle approaches and adapt them for regulatory purposes.
Data Collection & Management:
○ Gather life cycle inventory (LCI) data from internal teams and external sources, including contract manufacturing partners.
○ Aggregate, clean, and operationalize large datasets for use in LCA modeling.
Compliance Analysis:
○ Analyze existing LCA methodologies for compliance with international standards (e.g., ISO 14040/14044) and country-specific regulations, including France’s Climate and Resilience Law.
○ Ensure adherence to best practices in environmental labeling and sustainability reporting.
Collaboration & Stakeholder Engagement:
○ Work closely with stakeholders, including government bodies, pharmaceutical companies, and external consultants, to ensure accuracy and alignment with regulatory goals.
Programming & Data Science:
Leverage programming languages like R or Python for data analysis, modeling, and automation

Top Must Have Skill Sets:

Experience conducting cradle to grave life cycle assessments
Experience managing large data sets using programming tools such as R and Python
Experience gathering life cycle inventory data from external partners
Strong communication and data visualization skills

Day to Day Responsibilities:

Gather life cycle inventory data from external manufacturing partners
Efficiently aggregate and operationalize life cycle data
Apply client's life cycle analysis methodology to calculate cradle to grave life cycle assessment

Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience

Employee Value Proposition: Leading Biotech Industry Experience.

Interview Process:
Phone Screening
Panel Interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Technical Writing and Data Analysis – (JP13645) - Thousand Oaks, CA

Tue, 28 Jan 2025 15:17:36 GMT

Job Title: Associate Engineer, Technical Writing and Data Analysis – (JP13645)
Location: Thousand Oaks, CA. 91320 (hybrid)
Business Unit: Final Product Technology Development
Employment Type: Contract
Duration: 18+ months with likely extensions and/or conversion to a permanent position.
Rate: $32 - $35/hour W2
Posting Date: 1/28/2025.
Notes: Only qualified candidates need apply. Hybrid (onsite 3 days per week). Must be local to Thousand Oaks, CA

3 Key Consulting is hiring! We are recruiting an Associate Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Ideal candidate: Flexible with overtime during the week when necessary. Rarely will they need to work over 12 hours in a day. Preferring bachelor’s degree in Bioscience or Engineering. Technical writing and basic data analysis skills. Plus: Hands on lab experience

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for primary containers (vials, stoppers, and syringes) and medical devices.

Top Must Have Skill Sets:
•   Technical writing skills
•   Strong ability to analyze data generated from a variety of analytical techniques and systems is preferred
•   Previous lab experience in Engineering or Biochemistry labs is helpful but not required
•   Nice to have: CAD experience

Day to Day Responsibilities:
•   Employing basic science and engineering skills and practices to gather user requirements and translate them into technical documentation for execution
•   Assisting with project definition by performing engineering studies and assessments
•   Assist engineers with the following:
•   Designing studies and drafting protocols
•   Compiling historical data from different analytical systems
•   Analyzing data and presenting results
•   Writing summary reports
•   Executing protocols, including lab testing (using vacuum decay leak tester, Instron force testers, balances, microscopes, pressure chambers, analytical measurement equipment such as calipers, optical comparators, bore gauges, automated stoppering units, pipettes, and decrimpers).

Basic Qualifications:
•   Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
•   Previous lab experience
•   Strong oral and verbal communication and presentation skills
•   Experience in analysis of data generated from a variety of analytical techniques is preferred

Preferred Qualifications:

Red Flags:
•   Candidate has inflexible schedule
•   Candidate cannot work possible overtime
•   Candidate cannot work onsite at Thousand Oaks, CA
•   Bachelor’s degree not in Bioscience or Engineering

Why is the Position Open?
Supplement to the team

Interview Process:
One-on-one phone screening, followed by an in-person 1:6-10 person group interview
Interviews can start immediately

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Packaging Engineer, Technical Design & Artwork (JP13657) - New Albany, OH

Tue, 28 Jan 2025 10:29:29 GMT

Job Title: Associate Packaging Engineer, Technical Design & Artwork.- Biopharma (JP13657)
Location: New Albany, OH. 43054
Business Unit: Packaging Engineering group under Combination Product Operations (CPO)
Employment Type: Contract
Duration: 18+ months with likely extensions and/or conversion to a permanent position.
Rate: $26 - $30/hour W2
Posting Date: 1/28/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Associate Packaging Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
This position will report into the Packaging Engineering group under Combination Product Operations (CPO) in New Albany, Ohio (AOH). The role focuses on the development of engineering drawings and technical layout templates (TLTs) to support commercial artwork for labeling and secondary packaging printed components. Knowledge of labeling and secondary packaging design is key to the position. The position requires experience in multitasking different requests, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to a rapidly changing environment.

Top Must Have Skill Sets:
•   Bachelor’s in Design, Packaging, Engineering, or related field.
•   3 to 5 years of general design experience.
•   Independent thinker with demonstrated skills working in teams or leading project teams.
•   Strong interpersonal and communication skills.
•   Ability to quickly learn new concepts while paying close attention to details.
•   Experience in a GDP / GMP environment is a bonus.

Day to Day Responsibilities:
•   Creation of engineering drawings and technical layout templates (TLTs) to support commercial packaging artwork development.
•   Competency with AutoCAD, Adobe Creative Cloud (Illustrator, InDesign, Acrobat Professional), or similar software application to create, modify and approve engineering drawings and templates.
•   Familiarity with printing processes for labeling and packaging components.
•   Collaboration with cross-functional teams (i.e., Quality, Device Engineering, Supply Chain, Artwork, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.
•   Troubleshoot issues with packaging specifications and templates as related to Artwork.
•   Supporting Packaging Engineering team as needed to ensure project milestones are met.

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Preferred Qualifications:
•   Bachelor’s in Design, Packaging, Engineering, or related field.
•   3 to 5 years of general design experience.
•   Independent thinker with demonstrated skills working in teams or leading project teams.
•   Strong interpersonal and communication skills.
•   Ability to quickly learn new concepts while paying close attention to details.
•   Experience in a GDP / GMP environment is a bonus.

Red Flags:
Preference for local candidates if available.

Why is the Position Open?
Supplement additional workload on team

Interview Process:
Video conference

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, GMP Drug Delivery Medical Device (JP13653T) - Thousand Oaks, CA

Mon, 27 Jan 2025 19:01:27 GMT

Job Title: Engineer, GMP Drug Delivery Medical Device (JP13653C)
Location: Cambridge, MA 02138 OR Thousand Oaks, Ca.
Business Unit: Physical Methods Development, Modelling and Emerging Method
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: 38-42$/hours W2 with benefits
Posting Date: 1/27/2025
Target Start Date: 2/24/2025

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: Ideal candidate: 3 YOE in field desired with bachelors. Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired. Mathematical background fundamentals of statistics. Useful to have exposure to test method development, CAD design, SolidWorks, mechanical modeling. Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.
The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions
This may include, but is not limited to, the following:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data
Network with manufacturing and quality organizations internal to company
Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
Monitoring technological developments in the field & evaluation of new technologies

Preferred Skills:

Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:

Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project

Top Must Have Skill Sets:

Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics
Ability to manage multiple, competing priorities simultaneously,

Day to Day Responsibilities:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Run Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Employee Value Proposition: Possibility of extension or conversion if FTE position comes available.

Interview Process:
Phone Screening
Panel Interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, GMP Drug Delivery Medical Device (JP13653C) - Cambridge, MA

Mon, 27 Jan 2025 19:00:43 GMT

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data
Network with manufacturing and quality organizations internal to company
Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
Monitoring technological developments in the field & evaluation of new technologies

Preferred Skills:

Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:

Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project

Top Must Have Skill Sets:

Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics
Ability to manage multiple, competing priorities simultaneously,

Day to Day Responsibilities:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Run Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Employee Value Proposition: Possibility of extension or conversion if FTE position comes available.

Interview Process:
Phone Screening
Panel Interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13636) - Thousand Oaks, CA

Thu, 23 Jan 2025 15:36:18 GMT

Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13636)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities & Engineering Substance Supply
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 1/23/2025.
Notes: Only qualified candidates need apply. Initial schedule M-F for the first month of training. Flexibility in schedule, role has potential to move to a Sun-Wed 4 day x 10 hour shift (estimate start time 8 am)

3 Key Consulting is hiring! We are recruiting an Engineer, Upstream Drug Development Facilities & Engineering for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like CIP, COP, Autoclaves, and Glass Washers. Has a strong foundation in engineering principles, excellent communicator.

Seeking an Engineer at our client’s main headquarters in Thousand Oaks, CA to join the GMP Facilities and Engineering (F&E) organization. This position will provide on-site engineering support for the B23 Drug Substance Plant.

Under general supervision, provides equipment ownership by being SME of equipment. This position is to be the engineer for cleaning systems, which includes CIP (Clean In Place), COP (Clean Out of Place), Autoclaves and Glass Washers. Main function is to ensure equipment is running safely and reliably for production. Applies basic engineering principles to troubleshoot, design and implement system modifications, perform function tests for small projects. Organizes, analyzes and presents interpretation of results for engineering projects and/or issues of minor to medium scope and complexity. Support senior engineers for the implementation of complex projects.

Top Must Have Skill Sets:
•   Experience with regulated environments with working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech equipment.
•   Direct experience with manufacturing process equipment including troubleshooting, reliability and performance improvements, and design optimization.
•   Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
•   Must be able to communicate clearly. Required to communicate out issues and updates to broader audience.

Day to Day Responsibilities:
Equipment troubleshooting, improvement and reliability projects, ensuring that equipment WOs are completed on time

•   Function as a technical expert to equipment or systems.
•   Perform the system owner role for assigned systems to ensure equipment safety, reliability and compliance.
•   Work with manufacturing, maintenance, instrumentation, quality in order to resolve issues.
•   Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
•   Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses.
•   Specifying and overseeing a properly executed preventive maintenance program.
•   Specifying proper spare parts for system.

Basic Qualifications:
M.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.

Red Flags:
No troubleshooting or equipment ownership experience.

Why is the Position Open?
Supplement to the team’s workload.

Interview Process:
Interview with 3 engineers possibly in 1 to 2 interviews.
Can start interviewing ASAP.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Medical Device Root Cause Investigations (JP13462) - Thousand Oaks, CA

Mon, 13 Jan 2025 12:22:43 GMT

Job Title: Engineer Senior, Medical Device Root Cause Investigations (JP13462)
Location: Thousand Oaks, CA. 91320
Business Unit: Mechanical Autoinjectors Platform
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $50/hour W2
Posting Date: 1/213/2025.
Notes: Only qualified candidates need apply. 80% Onsite

3 Key Consulting is hiring! We are recruiting a Engineer Senior, Medical Device Root Cause Investigations for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have a B.S. and 5+ YOE experience in root cause investigations, change controls, deviations, and CAPA. Having Minitab and Pharma or med device background is a plus!

Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as:
•   Needle protection systems;
•   Fluid transfer devices;
•   Pen injectors;
•   Automatic pen injectors;
•   Micro-infuser delivery pump systems.

The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Top Must Have Skill Sets:
•   Previous experience in medical devices/pharma
•   Project management
•   Good Documentation Practices

Day to Day Responsibilities:
Worker must be able to accomplish given tasks with minimal supervision. Expectation is that worker will lead projects to completion and work cross functionally to overcome any technical hurdles.

•   Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
•   Create and assess product requirements to determine technical coverage and proper integration different subsystems.
•   Create and execute to project plans and schedules.
•   Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
•   Provide deep technical assistance for junior engineers.

Basic Qualifications:
•   Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

•   BS in Engineering and previous experience in a medical device industry

•   Experience with engineering processes and procedures.

•   Strong background in engineering and commercialization of electro-mechanical medical devices.

•   Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
•   Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
•   Experience in drug/device combination product design and development
•   Small scale device assembly experience.
•   Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
•   Strong problem solving, risk assessment, and risk management skills.
•   Must be capable of working on multiple projects in a deadline driven environment.

Red Flags:
No engineering degree/experience

Why is the Position Open?
Supplement to the team

Interview Process:
1 phone interview and 1 video call

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Technical Engineer - Pkg Equipment Maintenance - Biotech (JP13542) - New Albany, OH

Thu, 09 Jan 2025 13:32:58 GMT

Job Title: Associate Technical Engineer - Pkg Equipment Maintenance - Biotech (JP13542)
Location: New Ablany, OH. 43054
Business Unit: Pkg Engineering & Maintenance
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $33 - $40/hour W2 (or Market Rate)
Posting Date: 1/21/2025.
Notes: Only qualified candidates need apply. FULLY ONSITE NEW ALBANY OH. Day shift - 6:30am - 3pm (Shift times may vary)

3 Key Consulting is hiring! We are recruiting an Manufacturing Equipment Maintenance Technician for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Ideal Candidate: Looking for someone with some schooling and some maintenance experience or someone with no schooling and strong experience. Please read top 3 skillsets.

Manufacturing Equipment Maintenance Technician:
In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

Responsibilities:
•   Take part in the coordination of tech support on engineering, regulatory, compliance, quality, microbial/environmental, technical cleaning, validation, and mechanical, electrical and process automation issues.
•   Complete maintenance activities or operate and monitor plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and client policies.
•   Investigate equipment issues or problems through the mentorship of experienced staff.
•   Assist with maintaining an up-to-date working spare parts inventory system for the equipment/systems.
•   Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
•   Support Operations in non-standard shifts that includes weekends and/or holidays as determined by business.

Top Must Have Skill Sets:
•   Strong mechanical maintenance background in a manufacturing environment
•   Experience with CMMS, Maximo preferred
•   Experience working in a GMP environment

Day to Day Responsibilities:
•   Support the operations team by troubleshooting and maintaining pharmaceutical packaging equipment.
•   Take part in the coordination of tech support on engineering, regulatory, compliance, quality, microbial/environmental, technical cleaning, validation, and mechanical, electrical and process automation issues.
•   Complete maintenance activities or operate and monitor plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and client policies.
•   Investigate equipment issues or problems through the mentorship of experienced staff.
•   Assist with maintaining an up-to-date working spare parts inventory system for the equipment/systems.
•   Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
•   Support Operations in non-standard shifts that includes weekends and/or holidays as determined by business
Basic Qualifications:
•   High school/GED + 2 years Maintenance experience OR
•   Associate’s Degree + 6 months Maintenance experience
•   Bachelor degree OR Associate degree and 4 years of experience
•   High school diploma / GED and 6 years of experience

Preferred Qualifications:
•   Educational background in Mechanical Engineering, Mechatronics, or related technical degree
•   Experience repairing mechanical equipment in a manufacturing environment (experience with packaging equipment preferred)
•   Strong mechanical proficiency and trouble shooting skills
•   Understanding in PLC, Computer Serialization, Packaging Equipment, Vision Inspection Systems
•   Excellent organizational, project management, problem solving and technical writing capability
•   Strong communication: verbal / written, collaboration, influencing and facilitation
•   MS Office: Word, Excel, Power Point

Red Flags:
Short contracts less than 1yr, I understand having many roles for those in contract work, 1yr+ in a role is no issue.

Why is the Position Open?
Planned Project

Interview Process:
1:1 video call with hiring manager

Engineer, Drug Device Combination Product – Prefilled Syringes / Hybrid (JP13580) - Thousand Oaks, CA

Wed, 08 Jan 2025 13:29:05 GMT

Job Title: Engineer, Drug Device Combination Product – Prefilled Syringes / Hybrid (JP13580)
Location: Thousand Oaks, Ca.
Business Unit: Prefilled Syringes And Lyo Kit Platforms
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $36-41/hours W2 with benefits
Posting Date: 1/28/2025
Target Start Date: 2/3/2025

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:.
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of the company’s combination product portfolio.

Essential skills and Responsibilities:

Conducting hands-on experimental testing to support failure investigations and root cause analysis.
Developing, executing, and refining test procedures to evaluate device performance and functionality.
Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
Supporting design changes by leading testing efforts to assess and validate proposed modifications.
Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
Enhancing and expanding company’s delivery device platform as needed to meet evolving product and regulatory requirements.
The ideal candidate will:
Have strong laboratory testing experience, particularly with combination products and medical devices.
Possess a solid foundation in experimental methods and data analysis.
Be proficient in statistical tools and methodologies.
Demonstrate experience in failure analysis and implementing design solutions.
Have a proven ability to collaborate effectively within cross-functional teams.
Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
Show familiarity with regulatory and quality requirements for combination products and medical devices.
This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing the company’s portfolio of drug delivery devices.

Top Must Have Skill Sets:

Problem solving (engineering skillset)
Organization (self-starter and project level management)
Communication (experience communicating at different levels and to different groups)

Day to Day Responsibilities:

Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
System level root cause investigation
Coordinate and implement design improvements with development partners.
Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
Accountability of maintaining technical records within product design history files.
Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
Missing two or more of the following four items:
1. Degree in the field of Mechanical or Biomedical.
2. Medical device industry and/or regulated work environment experience.
3. Excellent written and verbal communication skill.
4. Understanding and experience in:
-Development/commercialization of medical devices and knowledge of manufacturing processes
-Initiating and bringing complex projects to conclusion
-Ability to work independently and dynamic cross functional teams
-Design controls
-Failure investigation
-Applied statistics

Additional stand-alone red flag: inability to be present on site/support onsite based activities. This is a hybrid role, NOT fully remote.

Interview Process:
Screening interview with myself, followed by a panel interview. Following the panel interviews, if a tie-breaker is needed, there may be a 3rd final round to go in depth on specifics the team felt needed further discussion.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Process & Controls Engineer (Automation Engineer)- (JP13565) - New Albany, OH

Tue, 07 Jan 2025 10:56:37 GMT

Job Title: Process & Controls Engineer (Automation Engineer)- (JP13565)
Location: New Albany, OH. 43054
Business Unit: Assembly & Packaging
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: Open/hour W2
Posting Date: 1/7/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Process & Controls Engineer (Automation Engineer) for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:

We are looking for a Process & Controls Engineer (Automation Engineer) who will take ownership of the technical aspects of a manufacturing line under general supervision. The ideal candidate will bring expertise in process optimization, troubleshooting operational issues, and supporting packaging operations, manufacturing, pilot technologies, and capital projects. The role involves applying fundamental engineering principles to the design and execution of system modifications, experiments, and smaller-scale capital projects. As a key technical resource, the Process & Controls Engineer will collaborate closely with mechanics, automation technicians, and IS teams to solve complex engineering problems and drive process improvements.

•   Standard business hours with some opportunity for overtime.
•   The department is responsible for maintaining pharmaceutical packaging line equipment and improvement projects to the packaging line process.
•   The consultant will come in and support packaging line equipment in place.
•   We are not looking to fresh out of school. Candidate should have at least 3-5 years of experience but seeking 5-10 years of experience. Must be a senior level leader.
•   PLC / HMI experience (Rockwell, Allen Bradley is highly preferred, Siemens is also okay)
•   Vision system experience is helpful but can be trained as long as PLC experience is there
•   Process and controls engineer experience
•   Electrical engineering / computer engineering degree aligns well with this role
•   GMP background is helpful (food/veterinarian background is transferrable)

Top Must Have Skill Sets:
•   Strong PLC and HMI Troubleshooting (Rockwell, B&R, Siemens)
•   Strong communication and teamwork skills
•   Root Cause Analysis and Troubleshooting

Day to Day Responsibilities:
•   Support the commercial operations of 7 packaging lines.
•   Lead small continuous improvement projects
•   Work with maintenance on breakdowns of packaging equipment.

Technical Ownership: Lead and manage the technical aspects of automation systems for packaging and ancillary equipment, ensuring optimal functionality and performance.

Process Optimization & Problem Solving: Analyze and develop strategies to optimize manufacturing processes, focusing on minimizing downtime and improving operational efficiency in a highly regulated environment.

Leadership & Collaboration: Lead cross-functional teams and projects, driving continuous improvement and automation initiatives across departments including Research, Manufacturing, Process Development, Quality Assurance, and Validation.

Engineering Design & Implementation: Contribute to the design, specification, and implementation of system modifications, experiments, and capital projects. Ensure effective deployment of new or improved engineering techniques and procedures.

Cross-Functional Coordination: Work with various departments to define and develop requirements for complex system modifications and facility improvements.

Documentation & Compliance: Ensure that all engineering processes, changes, and updates adhere to applicable industry standards (e.g., GMP, GAMP), maintaining compliance with relevant documentation and validation protocols.
Validation & Lifecycle Management: Oversee the lifecycle of automation systems, including design, installation, validation, and ongoing performance monitoring.

Basic Qualifications:
•   Master's degree in Engineering (preferred) OR
•   Bachelor's degree in Engineering with at least 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries OR
•   Associate’s degree in Engineering with 6 years of relevant experience in the Pharmaceutical, Medical Devices, or Biotechnology industries

Preferred Qualifications:
•   Advanced degree in Mechatronics, Computer Engineering, Electrical Engineering, Mechanical Engineering, or Chemical Engineering
•   Knowledge and experience with pharmaceutical/biotech processes, particularly in final drug product operations
•   Familiarity with Data Integrity and Data Security in regulated environments
•   In-depth experience with programming, design, installation, validation, and lifecycle management of manufacturing process controls and automation systems
•   Experience with Machine Vision, Serialization, Robotics, Siemens, and Rockwell software platforms
•   Strong understanding of GMP (Good Manufacturing Practices) and GAMP (Good Automated Manufacturing Practice), including associated documentation requirements in regulated industries
•   Experience with validation protocols and knowledge of the processes and requirements for new equipment installations
•   Strong project management skills with proven ability to handle complex tasks and drive improvements
•   Excellent verbal and written communication, presentation, and technical writing skills
•   Proven ability to collaborate with cross-functional teams and lead projects from conception to completion
•   Familiarity with Operational Excellence and Lean Transformation principles, particularly in automation and engineering contexts
•   Expertise in PLC and HMI programming with specific experience in Rockwell, B&R, and Siemens systems

Red Flags:
•   Validation Engineer.
•   No engineering experience.
•   No controls experience.

Why is the Position Open?
Supplement additional workload on team.

Interview Process:
Virtual

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Product – Prefilled Syringes (JP13555) - Thousand Oaks, CA

Mon, 06 Jan 2025 14:27:24 GMT

Job Title: Engineer, Drug Product – Prefilled Syringes (JP13555)
Location: Thousand Oaks, Ca.
Business Unit: PFS And Lyo Kit Platforms
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $36-41/hours W2 with benefits
Posting Date: 11/20/2024
Target Start Date: 01/27/2025

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: has hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods, as well as proficiency in technical documentation and teamwork. They should have experience in regulated industries, preferably biopharma, biomedical, or medical devices, though aerospace or mechanical disciplines are acceptable. Proficiency in Microsoft Office is required, and CAD/SolidWorks skills are a plus. Entry-level candidates with practical experience, such as internships, are preferred, while overqualification (e.g., PhD or advanced degrees with extensive experience) is less desirable. Packaging engineering knowledge is a bonus but not mandatory.

Job Description:.
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as; Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.

Essential skills and Responsibilities:

Adheres to strict documentation practices in a GMP regulated environment
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
Authors and reviews technical documentation including protocols, reports, and technical assessments
Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Maintains combination product design history files for assigned products
Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
Provide general laboratory support including inventory management, sample shipments, and cleanup.
Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
At a minimum familiar with the following standards and regulations:
Quality System Regulation – 21CFR820
Risk Management – ISO 14971
EU Medical Device requirements – Council Directive 93/42/EEC

Preferred Qualifications:

Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
Minimum 2 year of scientific or engineering experience in a GMP regulated environment
Statistical Analysis software (Minitab or JMP)
Strong technical writing skills
CAD fixturing software (SolidWorks)
Instron force tester using BlueHill Universal
Experience with design controls; including (but not limited to) verification and design transfer
Understanding of risk assessments including hazard and probability analysis
Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
Ability to work independently and dynamically across functional teams
Excellent written and verbal communication skills
Ability to support complex workstreams under demanding timelines

Top Must Have Skill Sets:

Authors and reviews technical documentation including protocols, reports, and technical assessments
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.

Day to Day Responsibilities:

The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space.
The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards.
Laboratory testing will primarily include the use of an Instron force tester and vision systems.
The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material.
Fill-Finish experience is a bonus but not mandatory.
Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.

Lack of hands-on experience in engineering or a translatable field like farming or factory work.
Poor communication or teamwork skills, especially for candidates with no collaborative experience.
Unwillingness to relocate or commute daily to ATO for this on-site role.
Weak technical writing skills.
Reliance solely on theoretical or textbook knowledge without practical application.
No experience in relevant industries, such as medical device manufacturing, biopharma, or packaging.
PhDs or Masters candidates that have over 3 Years of experience

Interview Process:
Screening and then move to 1:3 team members.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Principal Automation Engineer, (JP13398) - Thousand Oaks, CA

Mon, 06 Jan 2025 12:30:19 GMT

Job Title: Principal Automation Engineer, (JP13398)
Location: Thousand Oaks, CA. 91320
Business Unit: Advanced Technology and Automation: Manufacturing & Clinical Supply (MCS) – Facilities & Engineering (F&E)
Employment Type: Contract
Duration: 2+ year with likely extensions and/or conversion to a permanent position.
Rate: $60 - $65/hour W2
Posting Date: 1/6/2025.
Notes: Only qualified candidates need apply. Mon thru Fri, 8am – 5pm (40 hours per week) + eventually some On-call support (1 week in 5)

3 Key Consulting is hiring! We are recruiting a Principal Automation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The successful candidate will be smart, self-motivator, experienced technically with plant Automation support and troubleshooting. Good proactive team player. Will be required to support Clinical & Commercial Plant Automation Programs and Capital Projects for client’s manufacturing group, including complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and operational excellence. This position requires an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies. This role is expected to deliver on assigned capital projects and daily plant support as required.

Top Must Have Skill Sets:
•   Life science experience
•   Rockwell Automation and/or DeltaV experience (site-based experience ideally).
•   GMP Manufacturing facility experience
•   Reliable/committed/flexible.
•   Ideally Degree educated, minimum 5 – 7 years relevant Automation experience including site work.

Day to Day Responsibilities:
•   Provide day-to-day support of ATO Drug substance operations
•   Represent plant automation team in Area WCTs
•   Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including External Workers (EWs), onboarding the EWs, and ensuring the direct reports’ adherence to client’s training requirements.
•   Represent Plant Automation team during the development of project plan, business case, and cost estimates in partnership with key customers and stakeholders – ATO MCS Plant Operations, Engineering, Operations Information Systems (OIS), Global Construction Project Management (GCPM), and provide necessary support to obtain funding approval.
•   Based on project scope, work with OIS to estimate manhours and required resources
•   Represent Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with Engineering and GCPM.
•   Represent Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
•   Represent Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and client’s CMDB systems.
•   Ensure compliance to client’s Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
•   Represent Plant Automation team and support functional area projects focused on improving process equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug substance and drug product manufacturing technologies into clinical/commercial facility.
•   As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
•   Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

Basic Qualifications:
•   Doctorate degree and 2 years of experience OR
•   Master degree and 6 years of experience OR
•   Bachelor degree and 8 years of experience OR
•   Associate degree and 10 years of experience OR
•   High school diploma / GED and 12 years of experience

Red Flags:
•   Lack of GMP Experience
•   Lack of Automation background

Interview Process:
Up to 3 interviews. Available to start interviewing from 01/06/25. Initially on a call, potential face to face for final interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Pharmaceutical Packaging and Validation, (JP13455) - New Albany, OH

Mon, 06 Jan 2025 11:34:41 GMT

Job Title: Engineer, Pharmaceutical Packaging and Validation, (JP13455)
Location: New Albany, OH 43054
Business Unit: Final Product Technologies CORE
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $34 - $37/hour W2
Posting Date: 1/6/2025.
Notes: Only qualified candidates need apply. * Must be flexible with shifts. 10% travel may be required.

3 Key Consulting is hiring! We are recruiting an Engineer, Pharmaceutical Packaging and Validation for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Please note that the candidate must be flexible with shifts. This position should not exceed 40 hours a week, but some overtime may be needed occasionally. 10% travel may be required. 60% of the time is going to be 8 AM- 5 PM ET, 40% of the remaining time will be off regular hours for 2nd or 3rd shift, Monday-Friday (1st is from 6 AM to 2 PM, 2nd is from 2-10 PM, 3rd is from 10 PM - 6 AM).

Our ideal candidate will have 2+ years of Pharmaceutical Packaging working experience. Knowledge of data analysis, CGMP documentation, and Packaging Equipment Validation. Must be motivated, and with some training, be able to work with minimum supervision in a GMP environment. Candidate must be a team player, process-driven and able to support process improvement. Candidate must be able to communicate well with different levels of the organization.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for Packaging Equipment commissioning, qualification, Characterization and Validation. Candidate will employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for Packaging Systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.

Top Must Have Skill Sets:
•   Packaging Process Experience
•   Leadership
•   Flexibility and works in teams

Day to Day Responsibilities:
Support Packaging Equipment characterization activities and New packing Lines introduction to commercialization,

Basic Qualifications:
•   Master degree OR
•   Bachelor degree and 2 years of experience OR
•   Associate degree and 6 years of experience OR
•   High school diploma / GED and 8 years of experience

Red Flags:
No FDA regulated industries Knowledge.

Interview Process:
Two rounds of Phone interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Process Engineer, (JP13534) - Holly Springs, NC

Thu, 02 Jan 2025 11:00:36 GMT

Job Title: Associate Process Engineer, (JP13534)
Location: Holly Springs, NC. 27540
Business Unit: Engineering Automation
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $28 - $32/hour W2
Posting Date: 1/2/2025.
Notes: Only qualified candidates need apply. 100% ONSITE - regular working hours - potential on call rotation occasionally.

3 Key Consulting is hiring! We are recruiting an Associate Process Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have a B.S. degree in chemical or mechanical engineering. Some pharma experience in drug substance manufacturing is a plus. Looking for a go getter with some general working experience. (Does not have to be related to this position.)

Top Must Have Skill Sets:
•   Strong working ethics
•   Strong communication
•   B.S. in chemical or mechanical engineering
•   Pharma experience

Day to Day Responsibilities:
•   Develop, coordinate, analyze, and present results for operational issues and engineering projects
•   Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.
•   Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements
•   Communicating with supervisor and support staff, highlighting issues and proposing solutions.
•   Work in a small group of engineers and/or technicians on an ongoing or project basis.
•   Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.
•   Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.
•   Provide system ownership for assigned equipment, and support operations at the site.
•   Provide engineering support for design, construction, startup, commissioning and qualification.
•   Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
•   Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to client manufacturing.
•   Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.
•   Lead the development of calibration/maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
•   Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations.
•   Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.
•   Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.
•   Monitor systems to identify performance risks and implement risk reduction strategies.
•   Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)
•   Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
•   Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
•   Own investigations of abnormal conditions through Deviation and business processes.

Basic Qualifications:
•   Bachelor’s degree, Or
•   Associate’s degree and 4 years of Process Engineer experience, Or
•   High school diploma / GED and 6 years of Process Engineer experience
•   Ability to provide On-Call support coverage nights and weekends, on a rotating basis.

Preferred Qualifications:
•   Bachelor’s degree in engineering or related technical field
•   Position requires strong written and verbal skills and the ability to work with minimum direction.
•   Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
•   Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
•   Ability to function within cross-functional teams and embrace a team-based environment.
•   Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services, and/or non-GMP Utilities preferred
•   Familiarity with designing and operating equipment used in biopharmaceutical manufacturing preferred

Interview Process:
Manager screening followed by panel interviews (potential for these to be in person).

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, BioPharma Data Analytics - Hybrid (JP13532T) - Thousand Oaks, CA

Mon, 30 Dec 2024 13:57:55 GMT

Job Title: Associate Engineer, BioPharma Data Analytics - Hybrid (JP13532)
Location: Thousand Oaks, CA Or Cambridge MA
Business Unit: Commercial DP - Digital Tech and Data
Employment Type: Contract
Duration: 12 months with possible extension or conversion to FTE
Rate: $30-35/hour W2 with benefits.
Posting Date: 12/30/2024.

3 Key Consulting is hiring! We are recruiting an Associate Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Remote Role - Candidates sitting near Cambridge, MA or Thousand Oaks, CA will be preferred and will be required to come into office once a month.
Standard Hours - 8am-5pm

Ideal candidate: some industry experience through internship or research projects with bachelors degree, Educational background in engineering, data sciences, biology, chemistry, or related discipline. Drug product experience in Fill finish or inspection. Experience with Excel, statistical process control, Spotfire or Tableau

Day to Day Responsibilities:

Implementation/enhancement of digital systems and automated analysis/visualization tools (Spotfire) that are utilized for streamlining data management and data monitoring
Data extraction, verification, analysis, and technical reports for process monitoring
Supporting investigations of adverse signals identified through process data monitoring
Integration of new products and processes to data monitoring business process and quality management system
Support for other ad hoc studies and projects as applicable (e.g. technology transfers of processes to new sites

Top Must Have Skill Sets:

Educational background in engineering, biology, chemistry, or related discipline
Manufacturing experience: strongly preferable for this experience to be in drug product/ pharmaceutical field Manufacturing experience in other fields also may be considered, depending on relevance of skills involved and transferability/applicability to this position
Experience with data entry, verification, analysis, and/or data management IS systems

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Red Flags:
1) Lack of consistency, focus, or direction (in terms of career trajectory and interests)
2) Lack of clear interest in or motivation for taking on this specific role

Why is the Position Open?
Supplement additional workload on team

Interview Process:
1) Phone screen
2) Video conference (manager; also preferably 1+ team members)

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, CQV & Troubleshoot Biopharma Analytical Equipment (JP13477) - Thousand Oaks, CA

Thu, 12 Dec 2024 15:34:09 GMT

Job Title: Engineer Senior, CQV & Troubleshoot Biopharma Analytical Equipment (JP13477)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 02/26/2025.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate with have:
•   5+ YOE and B.S.
•   Must have Analytical Equipment Troubleshooting.
•   Must have Commissioning, Qualification, and Validation of Analytical Equipment.
•   Must have Manufacturing Support

The Sr. Engineer, Analytical will lead the troubleshooting and vendor support for a wide variety of analytical equipment that supports manufacturing. Scope includes a wide range of devices such as Cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers. The qualified candidate will work with the analytical team to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities. Responsibilities include:
•   Working cross-functionally with individuals and project teams in Analytical, Engineering, Instrumentation, and Manufacturing.
•   Determine technical coverage and proper integration of different subsystems.
•   Create and execute to project plans and schedules.
•   Review qualification documents and other related development documents for assigned projects.
•   Provide deep technical assistance for other support staff and operators using equipment.
•   Support of different equipment in multiple buildings within the Thousand Oaks campus

Top Must Have Skill Sets:
•   5+ YOE and B.S.
•   Must have Analytical Equipment Troubleshooting.
•   Must have Commissioning, Qualification, and Validation of Analytical Equipment.
•   Must have Manufacturing Support

Day to Day Responsibilities:
•   Hands on troubleshooting of analytical equipment
•   Coordination of vendor support
•   Project support for commissioning, qualification, validation, and decommissioning
•   Execution of preventative maintenance, user access audits, password management
•   Support of different equipment in multiple buildings within the client’s Thousand Oaks campus

Basic Qualifications:
•   BS in Engineering, Biotech, Chemistry, or Equivalent
•   Previous experience in a biotech/pharmaceutical industry with focus on usage and/or analytical equipment of specified equipment
•   5 years current experience with analytical processes and GMP procedures.
•   Strong background in troubleshooting, root cause analysis, and vendor coordination.
•   Must be capable of working on multiple projects in a deadline driven environment.

Red Flags:
•   Less than 3 years of experience
•   Experience that does not include analytical / in-process testing equipment
•   Experience that does not include hands on troubleshooting and root cause analysis

Why is the Position Open?
Supplement to the teams current workload

Interview Process:
Initial Interview, then Panel

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Reliability Engineer Senior, Pharma Equipment/Facilities (JP13468) - Thousand Oaks, CA

Wed, 04 Dec 2024 18:05:41 GMT

Job Title: Senior Reliability Engineer Senior, Pharma Equipment/Facilities (JP13468)
Location: Thousand Oaks, Ca. 100% onsite.
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $44 - $50/hr. W2 with benefits
Posting Date: 12/04/2024

3Key Consulting is hiring! We are recruiting an Engineer Reliability Senior, Biotech Manufacturing and Process Equipment for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: Bachelor Engineering process mechanical degree and 5 years of process equipment experience

Job Description:
This engineering position supports manufacturing activities associated with cGMP equipment and facilities. The senior engineer works in partnership with the automation, maintenance, and manufacturing teams to develop and oversee the reliability of equipment while driving safety and quality compliance. The engineer will provide data to support business cases and long-term strategy.

The Senior Engineer role will provide direct engineering technical support as follows:

Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.
Be accountable for manufacturing equipment reliability
Suggest design modifications to address risks and design in quality and safety.
Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation

Top Must Have Skill Sets:

Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Direct knowledge of design and troubles hooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

Day to Day Responsibilities:

Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order
Monitor systems to identify performance risks and implement risk reduction strategies
Providing trouble shooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action

Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience.

Why is the Position Open?
Supplement additional workload on team

Red Flags:
No prior process equipment experience

Interview Process:
1. First round: Screening with hiring manager.
2. Second round: Panel interview with senior engineers

Candidates should come prepared with examples of past problem-solving and equipment reliability work
Prefer examples showing deep understanding of equipment and how issues were addressed

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Systems Engineer, Biopharma/Medical Device - Remote PST (JP13467) - Thousand Oaks, CA

Wed, 04 Dec 2024 17:13:43 GMT

Job Title: Systems Engineer, Biopharma/Medical Device - Remote PST (JP13467)
Location: Thousand Oaks, CA. 91320 (100% Remote)
Business Unit: Systems Engineering Group
Employment Type: Contract
Duration: 18+ months with likely extensions and/or conversion to a permanent position.
Rate: $45 - $50/hour W2
Posting Date: 12/04/2024.
Notes: Only qualified candidates need apply. Regular working hours PST. Candidates must have experience in requirements authoring tools such as DOORS, 3DS Requirements Management (Dassault), Requisite Pro, etc. and must be shown on resume.

3 Key Consulting is hiring! We are recruiting a Systems Engineer & Systems Requirements Expert for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!

Senior level role. Candidate must have experience in the Biotech, pharma, med device industry. Candidate must have systems engineering background for at least 5 years. Great communication, can lead meetings and work screens. Candidate must have:
•   Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, 3DS (Dassault), Requisite Pro, or other similar requirements management software.
Nice to have:
•   Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts.

The Systems Engineer (SE) works as part of cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of a combination product development program. The SE understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied, identifies technical risks and assists risk retirement activities on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.

Top Must Have Skill Sets:
•   Systems Engineering past work experience.
•   Past experience in writing Requirements using Requirements Management Tool such as DOORS, 3DS Requirements Mgmt (Dassault) etc
•   Proficient in Microsoft Excel especially in writing macros in excel and or SmartSheet.

Day to Day Responsibilities:
•   Responsible for writing technical and guidance documents that provides guidance to team members in following Requirements Management Toolset such as 3DS.
•   Develop Toolsets using Microsoft excel or SmartSheet to enable easier on boarding of other engineers onto client processes
•   Work and Lead cross functional teams in development of common practices and write technical guidance documents to enable consistency across various combination product teams.

Candidate will work cross-functionally with individuals and project teams in Marketing, Operations, and Development - Create and assess product requirements to determine technical coverage and proper integration different subsystems. - Create and execute to project plans and schedules - Develop, execute, and review requirements documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.

Basic Qualifications:
•   Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
•   BS in Engineering and 5 years’ previous experience in a medical device industry - 10 years current experience with engineering processes and procedures.

Preferred Qualifications:
•   6+ years of progressive experience as an engineer or scientist within the appropriate field of study (Systems Engineering)
•   Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
•   Experience in combination product development.

Red Flags:
•   No Degree
•   No Systems Engineering Background

Why is the Position Open?
Planned Project

Interview Process:
•   Video Conference with Hiring Manager.
•   After initial Interview a panel interview (Video Conference) with additional hiring team.
•   Candidate must be comfortable in Web-Cam / Video Conference interview screening.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Process Engineer - Biopharma (JP13416) - Holly Springs, NC

Tue, 26 Nov 2024 12:41:57 GMT

Job Title: Associate Process Engineer - Biopharma (JP13416)
Location: Holly Springs, NC. 27540
Business Unit: Engineering & Automation
Employment Type: Contract
Duration: 12 months with possible extensions or conversion to FTE
Rate: $30-33/hr W2 with benefits
Posting Date: 11/26/2024
Note: 100% onsite - regular working hours - potential on call rotation occasionally.

3Key is hiring! We are looking for Associate Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: B.S. in chemical or mechanical engineering. Some pharma experience in drug substance manufacturing is a plus. Looking for a go getter with some general working experience. (Does not have to be related to this position.)

Key Responsibilities:

Develop, coordinate, analyze, and present results for operational issues and engineering projects
Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.
Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements
Communicating with supervisor and support staff, highlighting issues and proposing solutions.
Work in a small group of engineers and/or technicians on an ongoing or project basis.
Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.
Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.
Provide system ownership for assigned equipment, and supporting operations at the site.
Provide engineering support for design, construction, startup, commissioning and qualification.
Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.
Lead the development of calibration/maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations.
Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.
Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.
Monitor systems to identify performance risks and implement risk reduction strategies.
Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
Own investigations of abnormal conditions through Deviation and business processes.

Basic Qualifications:

Bachelor’s degree Or Associate’s degree and 4 years of Process Engineer experience Or
High school diploma / GED and 6 years of Process Engineer experience.
Ability to provide On-Call support coverage nights and weekends, on a rotating basis.

Preferred Qualifications:

Bachelor’s degree in engineering or related technical field
Position requires strong written and verbal skills and the ability to work with minimum direction.
Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
Ability to function within cross-functional teams and embrace a team-based environment.
Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services, and/or non-GMP Utilities preferred
Familiarity with designing and operating equipment used in biopharmaceutical manufacturing preferred

Top Must Have Skill Sets:

Strong working ethic
Strong communication
B.S. in chemical or mechanical engineering
Pharma experience

Employee Value Proposition:
Unique industry experience
Career growth
Networking

Interview Process:
Manager screening followed by panel interviews (potential for these to be in person).

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer (Mechanical) - Biotech Packaging Lines (JP13436) - New Albany, OH

Mon, 25 Nov 2024 15:44:42 GMT

Job Title: Engineer, Biotech Packaging Line Mechanical (JP13436)
Location: New Albany, OH. 43054
Business Unit: Assembly & Packaging
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: Open Market Rate/hour, W2 with Benefits
Posting Date: 1/10/2024.
Notes: Only qualified candidates need apply. Fully onsite in New Albany OH. 43054

3 Key Consulting is hiring! We are recruiting an Engineer (Mechanical) - Biotech Packaging Lines for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
In this role the Line Owner/System Owner must work under general supervision, owning all the technical aspects in a manufacturing line. The processes where the SO/LO Engineer shall be familiar with are:

Characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects.
Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

Experience with packaging equipment, specifically pharmaceutical, food, or beverage.
Experience with GMP environments.
Good communication skills, troubleshooting skills, and a team player.
Looking for Mechanical engineer over an industrial engineer (industrial is OK with relevant experience)

Day to Day Responsibilities:
Specific responsibilities include but are not limited to:

Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
Initiate and complete routine technical tasks.

Operations Engineering:

Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.

Design Engineering:

Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects and engineering firms on development of standard design documents.
Acquire and critique quotes for equipment modifications or installations.
Generate rudimentary project cost estimates and schedules.

Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
Knowledge of pharmaceutical/biotech processes
Familiarity with validation processes for Packaging areas
Familiarity with serialization process and networking
Familiarity with documentation in a highly regulated environment
Ability to operate specialized equipment, tools and computers as appropriate.
Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
Ability to apply engineering science to production.
Able to develop solutions to routine technical problems of limited scope
Comprehensive understanding of protocol requirements.
Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
Excellent communication (verbal/written) and presentation skills
Demonstrated interpersonal skills including; collaboration, influencing, and facilitation
Protocol and script testing Writing
Dealing with and handling change
Packaging Equipment Technical knowledge
Analytical Problem Solving
Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context

Why is the Position Open?
Supplement additional workload on team.

Red Flags:
Misspellings in Resume.
Long Resumes without descriptive content.

Interview Process:
One phone and one virtual panel interview.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Electromechanical Medical Device - Hybrid (JP13404) - Thousand Oaks, CA

Thu, 21 Nov 2024 16:01:04 GMT

Job Title: Engineer, Electromechanical Medical Device - Hybrid (JP13404)
Location: Thousand Oaks, Ca. (2-3 times/month onsite)
Business Unit: Electromechanical Platform
Employment Type: Contract
Duration: 3 years with likely conversion to perm
Rate: $36-41/hours W2 with benefits
Posting Date: 11/21/2024
Target Start Date: 01/13/2025

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate:
Self-sufficient, team-oriented candidate with strong communication and technical documentation skills. Ideal candidates should have electromechanical or engineering experience, proficiency in complaint management systems, and knowledge of CAPA processes and GDP. Familiarity with Excel for data analysis. Stability and a bachelor’s degree with a few years of relevant experience are preferred.

Medical device industry experience and regulated work environment experience.
Strong understanding and experience in design controls, failure investigation (leading an investigation)

Job Description:
Perform Sustaining Engineering activities of combination products with electromechanical delivery systems. Such activities support the identification, review, assessment, and resolution of deficiencies throughout the product’s life cycle. Responsible for product life cycle change management and ensures design controls are documented in accordance with internal procedures. Support multi-functional assessment of complaint records

Top Must Have Skill Sets:

Ability to clearly communicate with diverse teams, including Engineering, Manufacturing, Regulatory, and Quality colleagues.
Strong written skills for documenting changes, updates to risk files, and communication with leadership.
Multidisciplinary assessment of complaints and problem-solving.

Day to Day Responsibilities:

Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained
Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership
Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues
Establish experimental protocols, conduct experiments, analyze results
Support technical execution of Design History File (DHF) updates
Establish and maintain relationships with manufacturing site colleagues
Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes
Establish and review specifications/requirements for components, products and processes
Support CAPA investigations
Ensures product conforms to current relevant international standards
Support multi-functional assessment of complaint record

Difficulty clearly communicating with cross-functional teams or documenting changes effectively.
Lack of precision or detail in written documentation
Inability to convey project progress or results to leadership, leading to misunderstandings or misalignment

Interview Process:
Screening interview with the hiring manager followed by team interview.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Product – Prefilled Syringes (JP13400) - Thousand Oaks, CA

Wed, 20 Nov 2024 17:06:02 GMT

Job Title: Engineer, Drug Product – Prefilled Syringes (JP13400)
Location: Thousand Oaks, Ca.
Business Unit: PFS And Lyo Kit Platforms
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $36-41/hours W2 with benefits
Posting Date: 11/20/2024
Target Start Date: 01/06/2025

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: has hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods, as well as proficiency in technical documentation and teamwork. They should have experience in regulated industries, preferably biopharma, biomedical, or medical devices, though aerospace or mechanical disciplines are acceptable. Proficiency in Microsoft Office is required, and CAD/SolidWorks skills are a plus. Entry-level candidates with practical experience, such as internships, are preferred, while overqualification (e.g., PhD or advanced degrees with extensive experience) is less desirable. Packaging engineering knowledge is a bonus but not mandatory.

Job Description:.
The Device Engineer will participate in the design, development, and lifecycle management design control activities for commercialized drug delivery devices. This role includes technical operations support for combination product development to global launch, clinical and commercial manufacturing, failure investigation, design change evaluation, development and execution of test procedures, and continuous improvement initiatives.
Scope includes mechanical delivery devices, such as; Prefilled syringes. The qualified candidate will be part of a sustaining device engineering team that ensures design history files of these mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as the development of product enhancements, analytical failure analysis and implementation of design solutions, assessment of proposed changes, support product launches, defend inspection and ensure the follow through of commitments.

Essential skills and Responsibilities:

Adheres to strict documentation practices in a GMP regulated environment
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.
Authors and reviews technical documentation including protocols, reports, and technical assessments
Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Maintains combination product design history files for assigned products
Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
Provide general laboratory support including inventory management, sample shipments, and cleanup.
Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization
At a minimum familiar with the following standards and regulations:
Quality System Regulation – 21CFR820
Risk Management – ISO 14971
EU Medical Device requirements – Council Directive 93/42/EEC

Preferred Qualifications:

Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
Minimum 2 year of scientific or engineering experience in a GMP regulated environment
Statistical Analysis software (Minitab or JMP)
Strong technical writing skills
CAD fixturing software (SolidWorks)
Instron force tester using BlueHill Universal
Experience with design controls; including (but not limited to) verification and design transfer
Understanding of risk assessments including hazard and probability analysis
Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
Ability to work independently and dynamically across functional teams
Excellent written and verbal communication skills
Ability to support complex workstreams under demanding timelines

Top Must Have Skill Sets:

Authors and reviews technical documentation including protocols, reports, and technical assessments
Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.

Day to Day Responsibilities:

The device engineer will support a senior engineer on a variety of projects related to laboratory testing, life cycle management, and product-based initiatives regarding prefilled syringes in both the commercial and developmental space.
The engineer will be expected to author protocols, reports, and further technical documentation while adhering to GMP standards.
Laboratory testing will primarily include the use of an Instron force tester and vision systems.
The identified candidate must be able to lift up to 50 lbs for receipt and transferring of material.
Fill-Finish experience is a bonus but not mandatory.
Engineer will be evaluated on ability to complete a wide variety of supporting tasks for projects in a timely manner while maintaining a high standard of quality.

Lack of hands-on experience in engineering or a translatable field like farming or factory work.
Poor communication or teamwork skills, especially for candidates with no collaborative experience.
Unwillingness to relocate or commute daily to ATO for this on-site role.
Weak technical writing skills.
Reliance solely on theoretical or textbook knowledge without practical application.
No experience in relevant industries, such as medical device manufacturing, biopharma, or packaging.
PhDs or Masters candidates that have over 3 Years of experience

Senior Engineer, MES PAS-X Software - Biopharma – Hybrid (JP13409) - Thousand Oaks, CA

Fri, 15 Nov 2024 12:37:57 GMT

Job Title: Senior Engineer, MES PAS-X Software - Biopharma – REMOTE (JP13409)
Location: Thousand Oaks, CA. 91320 (REMOTE)
Business Unit: NPI/EBR Support
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $70 - $78/hour. Will consider higher rate for qualified candidate. With benefits
Posting Date: 11/15/2024.
Note: Local preferred but can be remote

3 Key Consulting is hiring! We are recruiting a Senior Software Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Support Drug Substance Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics, and for communication between the GMP operations teams and the process development scientific groups. This position will be focused on Electronic Batch Records for Drug Substance manufacturing.

Job scope and responsibilities:

Manufacturing Electronic Batch Record (EBR) generation using PAS-X (Korber)
Validation of new Electronic Batch Records (Application Lifecycle Management)
Assisting in implementation of new MES functionality
Develop standard work and business practices for new MES functionality
Contributing to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
Participate and contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.

Top Must Have Skill Sets:
MUST have strong PAS-X software experience for electronic batch records with detailed understanding of editing and validation
Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing

Basic Qualifications:
Doctorate Degree OR Master Degree and 3 years of Engineering experience OR Bachelor Degree and 5 years of Engineering experience OR Associate degree and10 years of Engineering experience

Preferred Qualifications:

Experience with PAS X (Korber) software for electronic batch records with detailed understanding of editing and validation
Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing
Demonstrated ability to work in a team
Degree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology

Red flags:
No PAS-X experience
Unable to speak to the experience listed on their resume

Why is the Position Open?
Supplement additional workload on team

Interview Process:
1) Phone Screening (Logistics and General knowledge questions)
2) Panel Interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Maintenance Technician Senior, BioPharma Facilities & Equipment (JP13397) - Thousand Oaks, CA

Tue, 12 Nov 2024 13:53:29 GMT

Job Title: Maintenance Technician Senior, BioPharma Facilities & Equipment (JP13397)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: Market Rate DOE, plus benefits
Posting Date: 11/12/2024.
Notes: Only qualified candidates need apply. Fully onsite in Thousand Oaks, CA. 12-hour shift (6:30PM-7:30AM), Thursday through Saturday, and alternating Wednesdays. ***

3 Key Consulting is hiring! We are recruiting a Maintenance Technician Senior for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
In this role, you will be expected to work a 12-hour shift (6:30PM-7:30AM), Thursday through Saturday, and alternating Wednesdays. The schedule during the initial on-boarding/training phase (2-6 weeks) will be Monday through Friday, approximately 8am to 5pm.

CANDIDATE MUST HAVE MAINTENANCE EXPERIENCE

The Sr. Maintenance Technician role will be responsible for performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of office utility and facility equipment used in manufacturing, utility plants, analytical labs, and office areas.

Top Must Have Skill Sets:

Must have hands-on maintenance experience and specific details outlined in resume
Troubleshooting system experience.
Must know, comprehend and apply packaging configurations, and understand follow and document batch records for the inspection and packaging process. Reconcile components and product exposure to room temperatures.
Filling and finishing manufacturing experience, preferably vial inspection; understanding of measurements, calculations and the metric system.
Basic GMP knowledge.
Good Communication.
Team Leadership.

Day to Day Responsibilities:

The Sr. Maintenance Technician role will be responsible for performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of a wide variety of office utility and facility equipment used in manufacturing, utility plants, analytical labs, and office areas. Responsibilities include:
Developing, writing, and completing various quality systems and safety documentation such as:
- Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc.
Responsible for various aspects of building, utility and production systems/equipment
All work must be completed in a safe (in accordance to HRA, JHA, etc), timely manner according to planning and predefined schedules with minimal impact to production while complying with Good Manufacturing Practices (GMP), SOP, Code of Federal Regulations (CFR) and company's procedures.
This role interacts with peers and clients in manufacturing, maintenance, utility plants, analytical labs and contracted services.
Provide training for staff, clients and projects, audit support, reviews and technically approves maintenance reports, forms, plans and records, develops, revises, and reviews equipment, maintenance or other related procedures, Interpret and revise loops sheets, electrical schematics, P&ID's, I/O wiring and panel drawings

Basic Qualifications:

Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Required to know, comprehend, and apply packaging configurations, as well as understand, follow and document batch records for the inspection and packaging process.
Reconcile components and products, and calculate product exposure to room temperatures;
filling and finishing manufacturing experience, preferably vial inspection; understanding of measurements, calculations and the metric system;
Basic GMP knowledge

Why is the Position Open?
Supplement additional workload on team.

Red Flags:
Poor communication skills.
Lack of details.

Interview Process:
WebEX.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, BioPharma Data Analytics - Hybrid (JP13391M) - Cambridge, MA

Tue, 12 Nov 2024 11:44:48 GMT

Job Title: Associate Engineer, BioPharma Data Analytics - Hybrid (JP13391M)
Location: Thousand Oaks, CA Or Cambridge MA
Business Unit: Commercial DP - Digital Tech and Data
Employment Type: Contract
Duration: 12 months with possible extension or conversion to FTE
Rate: $30-35/hour W2 with benefits.
Posting Date: 11/12/2024.

3 Key Consulting is hiring! We are recruiting an Associate Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Remote Role - Candidates sitting near Cambridge, MA or Thousand Oaks, CA will be preferred and will be required to come into office once a month.
Standard Hours - 8am-5pm

Ideal candidate: some industry experience through internship or research projects with bachelors degree, Educational background in engineering, data sciences, biology, chemistry, or related discipline. Drug product experience in Fill finish or inspection. Experience with Excel, statistical process control, Spotfire or Tableau

Day to Day Responsibilities:

Implementation/enhancement of digital systems and automated analysis/visualization tools (Spotfire) that are utilized for streamlining data management and data monitoring
Data extraction, verification, analysis, and technical reports for process monitoring
Supporting investigations of adverse signals identified through process data monitoring
Integration of new products and processes to data monitoring business process and quality management system
Support for other ad hoc studies and projects as applicable (e.g. technology transfers of processes to new sites

Top Must Have Skill Sets:

Educational background in engineering, biology, chemistry, or related discipline
Manufacturing experience: strongly preferable for this experience to be in drug product/ pharmaceutical field Manufacturing experience in other fields also may be considered, depending on relevance of skills involved and transferability/applicability to this position
Experience with data entry, verification, analysis, and/or data management IS systems

Associate Engineer, BioPharma Data Analytics - Hybrid (JP13391T) - Thousand Oaks, CA

Tue, 12 Nov 2024 11:40:12 GMT

Job Title: Associate Engineer, BioPharma Data Analytics - Hybrid (JP13391)
Location: Thousand Oaks, CA Or Cambridge MA
Business Unit: Commercial DP - Digital Tech and Data
Employment Type: Contract
Duration: 12 months with possible extension or conversion to FTE
Rate: $30-35/hour W2 with benefits.
Posting Date: 11/12/2024.

3 Key Consulting is hiring! We are recruiting an Associate Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Remote Role - Candidates sitting near Cambridge, MA or Thousand Oaks, CA will be preferred and will be required to come into office once a month.
Standard Hours - 8am-5pm

Ideal candidate: some industry experience through internship or research projects with bachelors degree, Educational background in engineering, data sciences, biology, chemistry, or related discipline. Drug product experience in Fill finish or inspection. Experience with Excel, statistical process control, Spotfire or Tableau

Day to Day Responsibilities:

Implementation/enhancement of digital systems and automated analysis/visualization tools (Spotfire) that are utilized for streamlining data management and data monitoring
Data extraction, verification, analysis, and technical reports for process monitoring
Supporting investigations of adverse signals identified through process data monitoring
Integration of new products and processes to data monitoring business process and quality management system
Support for other ad hoc studies and projects as applicable (e.g. technology transfers of processes to new sites

Top Must Have Skill Sets:

Educational background in engineering, biology, chemistry, or related discipline
Manufacturing experience: strongly preferable for this experience to be in drug product/ pharmaceutical field Manufacturing experience in other fields also may be considered, depending on relevance of skills involved and transferability/applicability to this position
Experience with data entry, verification, analysis, and/or data management IS systems

Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13348) - Thousand Oaks, CA

Tue, 05 Nov 2024 10:32:23 GMT

Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13348)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities & Engineering Substance Supply
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 11/5/2024.
Notes: Only qualified candidates need apply. Initial schedule M-F for the first month of training. Flexibility in schedule, role has potential to move to a Sun-Wed 4 day x 10 hour shift (estimate start time 8 am)

3 Key Consulting is hiring! We are recruiting an Engineer, Upstream Drug Development Facilities & Engineering for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like CIP, COP, Autoclaves, and Glass Washers. Has a strong foundation in engineering principles, excellent communicator.

Seeking an Engineer at our client’s main headquarters in Thousand Oaks, CA to join the GMP Facilities and Engineering (F&E) organization. This position will provide on-site engineering support for the B23 Drug Substance Plant.

Under general supervision, provides equipment ownership by being SME of equipment. This position is to be the engineer for cleaning systems, which includes CIP (Clean In Place), COP (Clean Out of Place), Autoclaves and Glass Washers. Main function is to ensure equipment is running safely and reliably for production. Applies basic engineering principles to troubleshoot, design and implement system modifications, perform function tests for small projects. Organizes, analyzes and presents interpretation of results for engineering projects and/or issues of minor to medium scope and complexity. Support senior engineers for the implementation of complex projects.

Top Must Have Skill Sets:
•   Experience with regulated environments with working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech equipment.
•   Direct experience with manufacturing process equipment including troubleshooting, reliability and performance improvements, and design optimization.
•   Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
•   Must be able to communicate clearly. Required to communicate out issues and updates to broader audience.

Day to Day Responsibilities:
Equipment troubleshooting, improvement and reliability projects, ensuring that equipment WOs are completed on time

•   Function as a technical expert to equipment or systems.
•   Perform the system owner role for assigned systems to ensure equipment safety, reliability and compliance.
•   Work with manufacturing, maintenance, instrumentation, quality in order to resolve issues.
•   Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
•   Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses.
•   Specifying and overseeing a properly executed preventive maintenance program.
•   Specifying proper spare parts for system.

Basic Qualifications:
M.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.

Red Flags:
No troubleshooting or equipment ownership experience.

Why is the Position Open?
Supplement to the team’s workload.

Interview Process:
Interview with 3 engineers possibly in 1 to 2 interviews.
Can start interviewing ASAP.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Automation Engineer Principal (DeltaV/PLC/Scada), Biopharma/GMP - (JP13312) - Thousand Oaks, CA

Fri, 01 Nov 2024 09:58:37 GMT

Job Title: Automation Engineer Principal (DeltaV/PLC/Scada), Biopharma/GMP - (JP13312)
Location: Thousand Oaks, CA. 91320
Business Unit: Advanced Technology & Automation
Employment Type: Contract
Duration: 3+ years with possible conversion to FTE
Rate: $60 - $70/hour W2 with benefits
Posting Date: 11/01/2024
Target start date: 12/02/2024

3 Key Consulting is hiring! We are recruiting an Automation Engineer Principal for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
We are seeking a professional Principal Automation Engineer for a long-term contracting opportunity with our client, a global leader in the biotech industry, as a member of the Manufacturing & Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team.

The successful candidate will be required to support Clinical & Commercial Plant Automation Programs and Capital Projects for the EPO Manufacturing team, including complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and operational excellence. This position requires an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies. This role is expected to deliver on assigned capital projects and drive accountability.

Top Must Have Skill Sets:

Life science experience
Rockwell Automation Experience
GMP Manufacturing facility experience
Onsite position

Day to Day Responsibilities:

Manage day-to-day support of ATO Drug substance operations
Represent plant automation team in Area WCTs
Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including External Workers (EWs), onboarding the EWs, and ensuring the direct reports’ adherence to client training requirements.
Represent Plant Automation team during the development of project plan, business case, and cost estimates in partnership with key customers and stakeholders – ATO MCS Plant Operations, Engineering, Operations Information Systems (OIS), Global Construction Project Management (GCPM), and provide necessary support to obtain funding approval.
Based on project scope, work with OIS to estimate manhours and required resources
Represent Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with Engineering and GCPM.
Represent Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
Represent Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and Client CMDB systems.
Ensure compliance to Client Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
Represent Plant Automation team and support functional area projects focused on improving process equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug substance and drug product manufacturing technologies into clinical/commercial facility.
As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
12) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

Basic Qualifications:
Doctorate degree and 2 years of experience or Master degree and 6 years of experience or Bachelor degree and 8 years of experience.

Preferred Qualifications:

Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product and Supply chain plant operations.
Has five or more years combined experience with the following automation systems:
- Emerson Delta-V DCS system.
- Rockwell Automation SCADA and PLC Platform.
- ABB Robot and Mitsubishi roller bottle machine
- Emerson Delta-V DCS system.
- Electronic Batch Reporting Systems Design and implementation experience.
- Process Control Network design including network segregation.
- Process Control Systems: Virtual Infrastructure design and implementation.
- System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
- Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.
Proficient in project management skills.
Ability to influence and motivate others outside of direct line of authority.
Strong ability to interface effectively with all levels.
Effective meeting management.
Quick learner; proactive; takes initiative.
Results oriented and goal driven.
Ability to organize, interpret, communicate, and/or present information.
Proficient facilitation, negotiation, problem-solving, and conflict resolution skills.
Strong oral and written communication skills.
Demonstrates willingness to put in extra effort when necessary to pursue tasks and conclusion.

Why is the Position Open?
Planned Project.

Red Flags:

Lack of GMP Experience
Lack of Automation background

Engineer, Drug Product Project Development (JP13343) - Thousand Oaks, CA

Thu, 31 Oct 2024 15:40:49 GMT

Job Title: Engineer, Drug Product Project Development (JP13343)
Location: Thousand Oaks, Ca.
Business Unit: Clinical Process Engineering
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $38-42/hours W2 with benefits
Posting Date: 10/31/2024
Target Start Date: 12/02/2024

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: The ideal candidate for this role should have a bachelor’s degree in any engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. They should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills. This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop over time.

Job Description:
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at Thousand Oaks and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of company products. The candidate will assist in establishing experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.
Responsibilities include, but are not limited to, the following:

Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable the implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
Support development and maintenance of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
Development of digital tools and models by leveraging data analytics and programming skills
Support at scale characterization and/or process validation runs as person in plant

Preferred Qualifications:

B.S. in engineering discipline with 1‒3 years’ experience or M.S. in engineering discipline with 0‒2 years’ experience
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude

Top Must Have Skill Sets:

Being able to articulate complex technical topics
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Ability to work independently and as part of a team with internal and external partners
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Strong cross functional team player with good communication skills (oral and written)

Manager notes from intake call-

This is a drug product processing group any familiarity with this (unit operations in scope of drug product would be very helpful!)
Strong interpersonal skills, must be motivated to learn, willing and comfortable with asking questions when they don't understand something and taking direction (rather than tasking based on assumption)
Strong ability to think critically build relationships
Able to work in a fast paced nuanced environment
Taking initiative

Day to Day Responsibilities:

Apply fundamental engineering and scientific
Support development and maintenance of technology transfer tools (clinical and commercial)
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Coordinate with cross-functional meeting to resolve manufacturing issue

Poor soft skill
Not willing to drive to the the campus on an as needed basis.
Experience on resume not reflective of actual work experience
Not being able to take direct feedback and apply to task assigned
Not having open communication and asking questions when there isnt an understanding of process or task

Interview Process:
Phone Screen 1:1
Virtual Conference Call then 2 1:1's

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Packaging Engineer Senior, Biopharma (JP13359) - New Albany, Oh

Thu, 31 Oct 2024 10:53:00 GMT

Job Title: Packaging Engineer Senior, Biopharma (JP13359)
Location: New Albany, Oh. 43054
Employment Type: Contract to Hire
Business Unit: Secondary Pkg Eng
Duration: 12 months with likely extension or conversion to permanent
Rate: $40-46 on W2 with Benefits
Posting Date: 10/31/2024

3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal candidate: Packaging education and experience is a requirement. AutoCAD and illustrator software requirements. 5 YOE in pharmaceutical packaging. Minimum of a bachelors in packaging. Open relocate on their own.

Job Description:
This position reports into the Packaging Engineering group under Combination Product Operations (CPO) and is located in New Albany, OH. The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position will apply engineering principles to implement the accurate design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. A knowledge of common materials utilized in healthcare packaging is key to this role. Material knowledge of structural components are integral in the day-to-day oversight of this role: bottles, labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc.

This role will/may have some entry level management potential and the successful candidate will also utilize excellent organizational, project management, technical problem solving and communication (written and verbal) skills, with the ability to work in teams and adapt to a rapidly changing environment.

This position is responsible and accountable for the following:

Lead testing and evaluations to recommend and select primary and secondary packaging materials for both large and small molecule products
Perform distribution testing per ASTM D4169. Complete testing standards using ASTM, ISO, TAPPI, USP and EP
Writing of test protocols, perform technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components
Creating specifications along with implementation through technical change records
Build, modify, and approve engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications
Assist in troubleshooting and leading investigations on Packaging Component problems for areas in production, warehouse, incoming inspection (minor and major deviation lead)
Support line trials and packaging validation activities prior to introduction of any new or change in components/processes
Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.) in pre-commercial and commercial activities

Bachelor’s degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industry

Demonstrated Competencies/Skills:

Familiar with distribution testing per ASTM D4169. Familiarity with ASTM, ISO, TAPPI, USP and EP testing standards.
Knowledge of primary and secondary packaging systems and material science is critical to the position
Strong organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to continuously evolving environment
Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Independent thinker with demonstrated skills working in teams or leading project teams
Strong interpersonal and communication skills

Why is the Position Open?
Supplement additional workload on team

Top Must-Have Skill Sets:

Ideal candidate: Packaging education and experience is a requirement.
AutoCAD and illustrator software requirements.
5 YOE in pharmaceutical packaging.
Minimum of a bachelors in packaging. Open relocate on their own.

Employee Value Proposition:
Opportunity, growth, experience

Red Flags:

No experience or knowledge of Packaging Engineering and no Packaging education
No experience in the medical industry
No knowledge of GDP

Interview process:
Webex meetings with multiple manager

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

Associate Manufacturing Systems Engineer, Biopharma (JP13361) - New Albany, Oh

Thu, 31 Oct 2024 10:33:55 GMT

Job Title: Associate Manufacturing Systems Engineer, Biopharma (JP13361)
Location: New Albany, OH. 43054
Business Unit: Package Engineering & Maintenance
Employment Type: Contract
Duration: Initial 6 months with possible extensions or conversion to FTE
Rate: Open Market Rate, W2 with Benefits
Posting Date: 10/31/2024
Note: Day shift- 6:30 am - 3 pm for first 3 months then will transition to 2nd shift 6 pm- 6 am (a few days on few days off)

We are looking for an Associate Manufacturing Systems Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Important Notes:
The work schedule for this role will be a first shift (Monday through Friday, approximately 6:30 am to 3 pm) and then move to an off-shift schedule (6pm-6am). As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across the company’s 24-hour operations. These shift structures can be a great opportunity to better support individual work/life priorities in Non-Standard Shifts structure.

Pre-screening questions required
All candidates must have responses to the below pre-screening questions from the job seeker:

What PLCs and HMIs do you have experience with?
Please explain the process for taking a computer and going online with a plc step by step.
a. This will be a very long and detailed explanation
What versions of Rslogix and Studio have you worked with? Follow up question would be is Studio 5000 backwards compatible.
If you have Rockwell HMI experience, what versions you worked with and what programming did you do? Have you worked with SE or ME?
What vision systems have you worked with? If Cognex or Keyence please list off some of the tools you used to programming (Software, and programing tools)

Job Description:
In this role you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. This client’s site is new advanced product assembly and packaging plant. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

Top Must Have Skill Sets:

PLC Experience
Electrical Troubleshooting
Technical Writing Capability
MUST BE SAFTEY ORIENTED
PLEASE NOTE SHIFT ABOVE

Preferred Qualifications:

Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
Other Automated Control Systems to be supported are: Siemens and Rockwell HMI’s, Cognex Vision System, Sensor and Systech Serialization
Experience with automation system hardware and software support, including installation
Excellent organizational, project management, problem solving and technical writing capability
Strong communication: verbal / written, collaboration, influencing and facilitation
MS Office: Word, Excel, Power Point

Day to Day Responsibilities:

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and company policies. Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&ID’s.
Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.

Employee Value Proposition:
Unique industry experience
Career growth
Networking

Red Flags:
Job hopping
Minimal work experience
Cannot work shift requirement

Interview Process:
30 Minutes with hiring manager
3 person panel 1 hour

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Physical Test Methods, Drug Delivery Device (JP13325) - Thousand Oaks, CA

Wed, 30 Oct 2024 16:42:26 GMT

Job Title: Engineer Senior, Physical Test Methods, Drug Delivery Device (JP13325)
Location: Thousand Oaks, CA. 91320
Business Unit: Physical Testing Systems Development
Employment Type: Contract
Duration: 18+ months with possible extension or conversion to FTE
Rate: $45 - $50/hour W2 with benefits
Posting Date: 10/30/2024
Notes: Monday, Wednesday, Friday (Remote)
Tuesday, Thursday (On site) 8am - 5pm (flex) / 7am- 4pm

3 Key Consulting is recruiting an Engineer Senior, Validation Physical Test Methods Combination Devices for a consulting engagement with our direct client, a leading global biotechnology company.
Looking for a candidate who has not job hopped every 6-8 months and has solid root cause analysis skills, technical writing, statistical background, CAD skills, thinker, problem solver, etc
Mainly Mechanical, Manufacturing, Biomedical engineers. Coding skills is a plus but not required. Candidates experience with Instron (or any other Force Tester), Keyence is a huge plus. Not so much candidates with QA/QE background are usually good with documents and statistics and not so much as a problem solver or overall technical.

Ideal candidate: Looking for a candidate with at least a Bachelor's degree and a lot of professional experience. Targeting at least 4 or more years of related work experience. Prefer to see candidates with work experience in the pharmaceutical industry, medical device industry or an industry that is highly regulated.

Job Description:
The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods for combination products, devices, primary containers, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

Top Must Have Skill Sets:

Engineering background (Mechanical, Biomedical, or Manufacturing)
Experience with CAD (SolidWorks preferred) & fixture or component design experience
Experience working in a regulated field (Medical devices, pharmaceutical, Aerospace, etc.)

Day to Day Responsibilities:

Assure transfer of new combination product test methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
Implement projects per Combination Product Operations (CPO) and company procedures to ensure projects are completed on schedule and within established budget.
Apply core engineering principles to develop physical test methods for medical device and combination product systems.
Perform data analysis to support method development, qualification, validation, and transfer
Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
Coordinate gauge and equipment development and delivery with selected contractors.
Ensure that qualification parameters are met for product assembly and performance requirements.
Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
Generate procedures necessary to support department and new product equipment.
Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).
Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
Excellent communication (written and verbal) and organizational skills
Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
Networks with manufacturing, quality and regulatory organizations both internal and external to client
Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverables and impacts to risk.
Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
Integrates partner/vendor timelines with client timelines as appropriate

Basic Qualifications:

Doctorate Degree OR
Master's Degree and 3 years of Engineering experience OR
Bachelor's Degree and 5 years of Engineering experience OR
OAssociate's degree and 10 years of Engineering experience OR
High school diploma/GED and 12 years of Engineering experience.

Preferred Qualifications:

M.S. or Ph. D. in Mechanical, Aerospace, Mechatronics, Chemical or Biomedical engineering
Excellent written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment
Experience with managing technical teams, including setting priorities and leveling resources
Technical writing experience
Spanish language skills preferred
Experienced with SolidWorks (or other 3D-CAD software)
Familiar with equipment and software IOQ
Experience with process characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs
Experience with change controls, deviations, CAPA
Experience with combination products and device regulatory requirements
Understanding of the six sigma process, utilizing Minitab (or other statistical software packages) to solve statistical problems
Work history with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing
Experience with machine controls (PLC, HMI) and vision systems

Why is the Position Open?
Supplement additional workload on team

Red Flags:
Job hopping (Every 6 months)
Not local (Greater LA area okay)
Gaps in experience (unaccounted)

Interview Process:
Initial phone screening with manager
Panel interview with team (either video or onsite)

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, GMP Drug Delivery Medical Device (JP13357T) - Thousand Oaks, CA

Wed, 30 Oct 2024 16:27:49 GMT

Job Title: Engineer, GMP Drug Delivery Medical Device (JP13357T)
Location: Cambridge, MA 02138 OR Thousand Oaks, Ca.
Business Unit: Physical Methods Development, Modelling and Emerging Method
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: 38-42$/hours W2 with benefits
Posting Date: 10/30/2024
Target Start Date: 11/25/2024

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: Ideal candidate: 3 YOE in field desired with bachelors. Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired. Mathematical background fundamentals of statistics. Useful to have exposure to test method development, CAD design, SolidWorks, mechanical modeling. Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.
The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions
This may include, but is not limited to, the following:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data
Network with manufacturing and quality organizations internal to company
Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
Monitoring technological developments in the field & evaluation of new technologies

Preferred Skills:

Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:

Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project

Top Must Have Skill Sets:

Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics
Ability to manage multiple, competing priorities simultaneously,

Day to Day Responsibilities:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Run Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Employee Value Proposition: Possibility of extension or conversion if FTE position comes available.

Interview Process:
Phone Screening
Panel Interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, GMP Drug Delivery Medical Device (JP13357C) - Cambridge, MA

Wed, 30 Oct 2024 16:25:48 GMT

Job Title: Engineer, GMP Drug Delivery Medical Device (JP13357C)
Location: Cambridge, MA 02138 OR Thousand Oaks, Ca.
Business Unit: Physical Methods Development, Modelling and Emerging Method
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: 38-42$/hours W2 with benefits
Posting Date: 10/30/2024
Target Start Date: 11/25/2024

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: Ideal candidate: 3 YOE in field desired with bachelors. Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired. Mathematical background fundamentals of statistics. Useful to have exposure to test method development, CAD design, SolidWorks, mechanical modeling. Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.
The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions
This may include, but is not limited to, the following:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data
Network with manufacturing and quality organizations internal to company
Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
Monitoring technological developments in the field & evaluation of new technologies

Preferred Skills:

Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:

Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project

Top Must Have Skill Sets:

Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics
Ability to manage multiple, competing priorities simultaneously,

Day to Day Responsibilities:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Run Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Employee Value Proposition: Possibility of extension or conversion if FTE position comes available.

Interview Process:
Phone Screening
Panel Interview

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Drug Product – Filling, Washers, Autoclaves (JP13326) - Thousand Oaks, CA

Tue, 29 Oct 2024 15:47:09 GMT

Job Title: Engineer, Drug Product – Filling, Washers, Autoclaves (JP13326)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Product Supply
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 10/29/2024.
Notes: Only qualified candidates need apply. No relocation candidates!

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have:

Bachelor’s degree with 2 years of experience in drug product manufacturing (PhD would be overqualified).
Previous experience in pharma or biotech industry with filling equipment.
GMP experience.
Experience with filling equipment, washers, and autoclaves desired.
Must have equipment trouble shooting & continuous on-going plant support experience.

The Engineer will be joining the Facilities & Engineering (F&E) group within Manufacturing, and Clinical supply organization at client. The group’s mission is to enable the introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably.

Top Must Have Skill Sets:

GMP Experience
Troubleshooting
Engineering

Day to Day Responsibilities:

Provide system ownership for Biopharmaceutical process and analytical equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.
Monitor systems to identify performance risks and implement risk reduction strategies.
Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
Resumes with only validation experience, but no engineering experience.

Interview Process:
Initial phone screen by me. Panel interview of candidates pass the phone screen.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Synthetics/Small Molecule Processes (JP13329) - Cambridge, MA

Tue, 29 Oct 2024 12:54:21 GMT

Job Title: Engineer, Synthetics/Small Molecule Processes (JP13329)
Location: Cambridge, MA. 02138
Business Unit: DTS Synthetics
Employment Type: Contract
Duration: 2+ years with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 10/29/2024.
Notes: Only qualified candidates need apply. **This is a 100% onsite position. Local candidates to Cambridge, MA only**

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:

We are looking for a proactive individual contributor who excels in teamwork, problem-solving and critical thinking.
Candidate must have experience in synthetics/small molecule processes.
We would like experience working in a kilo lab or small molecule manufacturing (preferable, but not a must have, this can be trained once the EW is in the role).

In this role, you will be responsible for supporting the process development and technical transfer of client’s synthetic drug substance processes by first demonstrating scale-up execution in the kilo lab. This role also requires acting as an equipment and instrument owner, and leading inventory maintenance and chemical/equipment ordering and shipping.
The Scale-up Lab (SUL) is integral to the optimization, scale-up, and technology transfer of client’s drug substance intermediates and final API. This enabling capability within the DSTS organization critically supports programs across all stages of development, including route selection, process optimization, and process characterization.

Top Must Have Skill Sets:

Experience working in a chemical synthesis lab
Individual contributor, able to perform tasks with minimal to no supervision
Good communication skills
Synthetics/small molecule processes
This role also requires acting as an equipment and instrument owner, and leading inventory maintenance and chemical/equipment ordering and shipping.

Day to Day Responsibilities:
Lead operations in the Scale-Up Lab (SUL):

Act as a superuser of all SUL equipment and accessories.
Provide on-the-floor support to ensure successful scale up and rapid problem solving and decision making.
Enable safe execution of SUL operations with minimal to no supervision.
Work closely with process development chemists and engineers to generate and interpret data, providing improved understanding and guidance for synthetic (small molecule) drug substances.
Executions of bench/kilo laboratory experimentation and process modeling/simulation to design and optimize robust synthetic processes.
Provide hands-on troubleshooting support related to processing and process equipment problems
Represent the organization within a multi-functional team to ensure deliverables are aligned with the timeline, ensuring key achievements are established and met.
Apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up
Author, review, and/or approve process documentation, master batch records, operational SOPs, and safety protocols needed to support SUL.
Order and maintian non-GMP chemical storage within SUL
Update compound and material inventory for projects to demonstrate in AMA SUL in coordination with step lead
Documentation of Real-Time Execution and Verification of Processing Steps in the Batch Sheet Instructions

Equipment upkeep and maintenance:

Coordinate equipment scheduling for new experiment requests.
Submit work orders, independently manage equipment maintenance, and support equipment troubleshooting.
Support preventative maintenance operations related to lab equipment and utilities, including, but not limited to, reactors, filters, rupture discs, heat transfer unit and chiller equipment.
Lead lab inventory management, including monitoring usage, ordering, and restocking of consumables.
Establish a management system for equipment replacement parts and maintain stock.
Demonstrate expertise with lab equipment handling and repair to troubleshoot challenges.
Execute Installation Operational Verification (IOV) and Evaluate Performance and Reliability of New Equipment

Lab improvements and knowledge management:

Support efforts for lab upgrades and optimization.
Assist in authoring training documentation for lab operations and equipment.
Monitor training compliance and coordinate training refreshers through the client’s training system.
Participate in and curate content for core and steering team meetings.
Participate in EHSS risk assessments and periodic reviews, acting as an SME.
Coordinate mitigations resulting from RAs and reviews.
Provide hands-on training and oversight for new users and refresher training for previous users.

Basic Qualifications:

Bachelor’s in chemistry or chemical engineering with at least two years of experience (can be academic or professional in the synthetics/small molecule processes).
High school diploma / GED and 8 years of related Engineering or Operations experience
Associate’s degree and 4 years of related Engineering or Operations experience
Bachelor’s or Master’s degree and 2 years of relatedEngineering or Operations experience

Preferred Qualifications:
Experience working in a kilo lab or small molecule manufacturing (preferable, but not a must have, this can be trained once the EW is in the role).

Interview Process:
2 Rounds; phone screen followed by final round either virtual or an onsite interview in Cambridge Office

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer Senior, Biopharma Packaging (JP13332) - Thousand Oaks, CA

Sat, 26 Oct 2024 12:46:00 GMT

Job Title: Engineer Senior, Biopharma Packaging (JP13332)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract to Hire
Business Unit: Design & Development
Duration: 12 months with likely extension or conversion to permanent
Rate: $48-52 on W2 with Benefits
Posting Date: 10/26/2024

3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This position reports into the Packaging Engineering group under Combination Product Operations in Thousand Oaks, CA. This position will apply engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment and processes. Knowledge of primary and secondary packaging systems and material science is essential to the position.

The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.

This position is responsible and accountable for the following:

Support for testing and evaluation leading to recommendation and selection of primary and secondary packaging materials.
Familiarity with Material Testing standards, requirements and equipment is essential.
Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components.
Writing technical specifications, creating engineering drawings, and developing artwork templates.
Competent with AutoCAD, Illustrator, or similar software application to create, modify and approve engineering drawings.
Support line trials and packaging validation activities prior to introduction of any new or change in components/processes.
Collaborate with cross-functional teams (i.e. Quality, Device Engineering, Supply Chain, Artwork, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities.

Preferred Qualifications:

BS Packaging, Mechanical Engineering, Chemical Engineering or Life Sciences
3+ years general packaging/engineering experience is strongly preferred
Knowledge of primary and secondary packaging systems and material science is essential to the position.
The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment.
Independent problem solver with demonstrated skills working in teams or leading project teams
Strong Interpersonal and communication skills

Why is the Position Open?
Staff Augmentation

Top Must-Have Skill Sets:

Packaging Engineering experience or/and Packaging education
Seeking level 4/5 engineer, 4+ years of experience
Experience working in the biotech/medical industry
Experience writing technical documentation while following good documentation practices (GDP), preferred

Day to Day Responsibilities

Authoring technical documentation (specifications, protocols, reports, technical assessments)
Oversee and manage packaging testing while following ASTM and ISO standards
Engage manufacturing site to help troubleshoot assembly issues
Engage suppliers to develop and revise designs

Employee Value Proposition:
Opportunity, growth, experience

Red Flags:

No experience or knowledge of Packaging Engineering and no Packaging education
No experience in the medical industry
No knowledge of GDP

Engineer Senior, Biotech Combination Products - Hybrid (JP13322) - Thousand Oaks, CA

Tue, 22 Oct 2024 14:33:03 GMT

Job Title: Engineer Senior, Biotech Combination Products - Hybrid (JP13322)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Device Strategy Technology Assessment
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $44 - $48/hour W2 with benefits
Posting Date: 10/22/2024.
Notes: Only qualified candidates need apply. Hybrid - 3 days onsite working primarily onsite in Thousand Oaks, with ability to work remotely. Bachelors Degree in Engineering. 5+ years of experience within Pharma, Biotech, Med Device

3 Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Combination Products for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Responsible for planning, executing and reporting test activities for combination product teams. Coordinates with technical leads and cross functional teams to ensure deliverables needed for device design feasibility, characterization and verification stages are completed on time with high quality standards.

Scope includes a wide range of devices, such as: needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors. The qualified candidate will coordinate with technical teams to ensure successful device development of these medical devices. The Senior Engineer will work closely with team members to develop detailed engineering deliverable timelines, directing and monitoring work efforts on a daily basis, identifying resource needs; and escalating functional, quality, timeline issues appropriately. The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.

Responsibilities include:

Create and maintain project timelines.
Ensures that the product development process abides by all defined cross-functional standards, meets the intent and letter of SOPs and all compliance and regulatory needs of the applicable markets.
Identifies early and solves complex and ambiguous cross-functional integration problems leading the team to deliver per Product team commitments including (but not limited to) completing functional goals, execution adjustments/iterations, and cross-functional teamwork.
Works with the Program Manager to ensure effective and efficient communication and execution for the duration of the cross-functional program team.
Works with the system, subsystem/platform, supply chain, service, QA, RA, Research project leaders to deliver quality products on time, within budget and with the necessary features/functionality.
Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Provide deep technical assistance for junior engineers.

Top Must Have Skill Sets:

Testing experience
Product Development
Experience with design controls and medical device regulations
Drug delivery/combination product experience
Risk-based process
Presentation skills

Day to Day Responsibilities:

Author device documentation to support development, planning, verification, validation, and transfer
Author test protocols and execute mechanical testing of drug delivery devices
Presentation and communication skills (within program teams)
Execute and deliver within regulated development processes
Proactively maintains close communication with technical leads

Basic Qualifications:

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
Bachelor's / Master's Degree in Electrical/Mechanical /Biomedical Engineering Computer Engineering or equivalent experience
Medical device and/or combination product development experience; design controls experience
5+ years of more progressive responsibility and experience as an engineer or scientist
Demonstrated ability to build lasting cross-functional relationships, including strong influential and communication skills
Demonstrated understanding/experience with the New Product Introduction (NPI) cycle and cross-functional interdependencies
Familiarity with test equipment such as Instron.

Red Flags:
Less than 5 years of experience, jumpy job history.

Why is the Position Open?
Supplement to current team

Interview Process:
2 rounds of interviews

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Job Title: Engineer – Design, Development, Lifecycle Management Drug Delivery Devices - (JP13249) - Thousand Oaks, CA

Tue, 15 Oct 2024 18:13:39 GMT

Job Title: Engineer – Design, Development, Lifecycle Management Drug Delivery Devices - (JP13249)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit:
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 12/19/2024.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Device Engineer will play a critical role in the design, development, and lifecycle management of drug delivery devices, including prefilled syringes, with a focus on testing and analysis within a laboratory environment. This position requires strong experimental, analytical, and statistical skills to support technical operations and ensure the success of clients’s combination product portfolio.

Key responsibilities include:
•   Conducting hands-on experimental testing to support failure investigations and root cause analysis.
•   Developing, executing, and refining test procedures to evaluate device performance and functionality.
•   Analyzing test data and applying statistical methods to derive actionable insights and recommendations.
•   Supporting design changes by leading testing efforts to assess and validate proposed modifications.
•   Participating in the scale-up, global launch, and continuous improvement of drug delivery devices.
•   Collaborating with contract manufacturers and suppliers to ensure device quality and performance standards are met.
•   Maintaining robust design history files for mechanical and electro-mechanical delivery devices.
•   Enhancing and expanding client’s delivery device platform as needed to meet evolving product and regulatory requirements.

The ideal candidate will:
•   Have strong laboratory testing experience, particularly with combination products and medical devices.
•   Possess a solid foundation in experimental methods and data analysis.
•   Be proficient in statistical tools and methodologies.
•   Demonstrate experience in failure analysis and implementing design solutions.
•   Have a proven ability to collaborate effectively within cross-functional teams.
•   Exhibit strong organizational skills and attention to detail, especially in maintaining design history files.
•   Show familiarity with regulatory and quality requirements for combination products and medical devices.
•   This role offers the opportunity to make a meaningful impact by leveraging technical expertise in a dynamic and innovative environment focused on advancing client’s portfolio of drug delivery devices.

Top Must Have Skill Sets:
•   Problem solving (engineering skillset)
•   Organization (self-starter and project level management)
•   Communication (experience communicating at different levels and to different groups)

Day to Day Responsibilities:
•   Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
•   Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
•   Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
•   System level root cause investigation
•   Coordinate and implement design improvements with development partners.
•   Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
•   Accountability of maintaining technical records within product design history files.
•   Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
•   Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Red Flags:
Missing two or more of the following four items:
•   Degree in the field of Mechanical or Biomedical.
•   Medical device industry and/or regulated work environment experience.
•   Excellent written and verbal communication skill.
•   Understanding and experience in:
o   -Development/commercialization of medical devices and knowledge of manufacturing processes
o   -Initiating and bringing complex projects to conclusion
o   -Ability to work independently and dynamic cross functional teams
o   -Design controls
o   -Failure investigation
o   -Applied statistics

Additional stand-alone red flag: inability to be present on site/support ATO-site based activities. This is a hybrid role, NOT fully remote.

Why is the Position Open?
Planned Project

Interview Process:
Screening interview with myself, followed by a panel interview. Following the panel interviews, if a tie-breaker is needed, there may be a 3rd final round to go in depth on specifics the team felt needed further discussion.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Project Engineer, Combination Products - Hybrid (JP13279) - Thousand Oaks, CA

Tue, 15 Oct 2024 16:39:56 GMT

Job Title: Project Engineer, Combination Products - Hybrid (JP13279)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Manufacturing Science and Technology
Employment Type: Contract
Duration: 2+ years with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 10/15/2024.
Notes: Only qualified candidates need apply. Onsite Thousand Oaks - 3 days a week. Schedule is typically 8am - 5pm
some flexibility with schedule, may be expected to work OT 10% of the time during peak season (Q4)

3 Key Consulting is hiring! We are recruiting a Project Engineer, Combination Devices for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have experience in a biotech and pharma GMP environment. Also, combination products, English written and verbal skills, MS Office, SmartSheets project scheduling software, Project management skills in a supporting role.

In this dynamic role you will organize Technology Transfer activities for Final Drug Product manufacturing. Supporting and creating project schedules, dashboards and leading team meetings to progress the project final objectives. This will include working across a global and cross functional team consisting of manufacturing, device and packaging design for combination product, capital projects, physical test methods, quality and regulatory team members. To effectively serve patients, we build effective Technology Transfer plan and schedule for our combination products that enhance end to end controls with robust methods with data flow to our digital infrastructure in a GMP setting.

Top Must Have Skill Sets:

Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
Direct experience with medical devices/combination products and associated manufacturing process.
Experience of working with equipment suppliers and contract manufacturers.

Day to Day Responsibilities:
The Process Engineer is expected to engage a network of FDP expertise across the client’s commercial and clinical operations for product (device) assembly, label and packaging. The position is expected to leverage this network in support of the technical transfer process, design for manufacturability of new combination products, performance trending of existing combination products, equipment standardization and troubleshooting/process improvements.

Supporting Tech Transfer project scheduling activities for FDP;
Support New Product Introduction to client manufacturing site;
Owning documentation such as Project Plan, supporting engineering with PTD (Process Transfer Document), Protocols and reports;
Supporting engineers with M-a-B (Make-a-Batch) activities to make sure the sending/receiving sites expectation are met;
Developing, tracking and providing project dashboard updates;
Providing good communication plan to cross functional team and Process Engineer management;
Ability to apply project management and engineering science to production;
Strong teamwork, excellent interpersonal and communication skills;

Basic Qualifications:

Master degree OR;
Bachelor degree and 2 years of experience OR;
Associate degree and 6 years of experience OR;
High school diploma / GED and 8 years of experience
Experience in a Combination Product field with a focus on project management and/or manufacturing.
Experience and knowledge of interdependencies of complex projects with new product introductions with new equipment/processes.
Knowledge of Combination Product design controls and Regulatory requirements on a global scale
Understanding of client commercialization framework.
Program and Project Management skills (experience with MS Project, SmartSheets and other project scheduling software is desired)
Proactive risk assessment, management and mitigation.
Ability to lead and succeed in ambiguous environment.
Strong project management skills.

Preferred Qualifications:
PMP certification is desired

Red Flags:
Candidates without pharma/biotech experience.

Why is the Position Open?
Supplement additional workload on team

Interview Process:
30 min interview with Hiring manager 1:1
50 min interview with 3:1 (interview panel)

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer – Bioprocessing Systems/Equipment - (JP13262) - Thousand Oaks, CA

Mon, 14 Oct 2024 15:00:43 GMT

Job Title: Engineer – Bioprocessing Systems/Equipment - (JP13262)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Product Supply
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 10/14/2024.
Notes: Only qualified candidates need apply. ONSITE THOUSAND OAKS, Local Candidates who can report to the site Monday – Friday. Flexible availability, schedule is 7am - 4pm need to be open to afterhours calls.

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The qualities and characteristics we are looking for in candidates include:

Fast learner
Strong critical thinking skills
Ability to handle stress well
Technically inclined with skills in electro-mechanical systems.
Candidates must show an engineering mindset, particularly those who use the scientific method to solve issues and provide examples of projects they have worked on.
Regarding the minimum education and experience requirements, a BA in Engineering, whether it be Mechanical, Industrial, or Electrical Engineering, is suitable for this role.
As for non-negotiables, candidates must have a degree in an engineering-related field and must be flexible with their working hours.

Our ideal candidate:

Highly motivated individual, system owner Mechanical and electrical engineering background.
Pharmaceutical industry manufacturing maintenance engineering and not operations side.
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.

The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization of our client. The group’s mission is to enable introduction, and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report to the Senior Manager of Engineering supporting drug product supply.

Top Must Have Skill Sets:

Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects

Day to Day Responsibilities:

Provide system ownership for Biopharmaceutical process equipment.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems.
This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Directing and coordinating equipment maintenance as necessary to ensure systems are working at peak capacity.
Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.
Monitor systems to identify performance risks and implement risk reduction strategies.
Solving issues to support and reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
Ensure regional medical activities align with practices, policies and standard operating procedures.

Bachelor’s degree in Chemical or Mechanical Engineering.
4+ years of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects

Red Flags:
No engineering experience

Interview Process:
1 phone screening
1 interview with hiring manager
1 panel interview with co-workers

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Reliability Engineer Senior, Pharma Equipment/Facilities (JP13179) - Thousand Oaks, CA

Fri, 04 Oct 2024 18:24:58 GMT

Job Title: Senior Reliability Engineer Senior, Pharma Equipment/Facilities (JP13179)
Location: Thousand Oaks, Ca. 100% onsite.
Business Unit: Facilities and Equipment Drug Substance Supply
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $44 - $50/hr. W2 with benefits
Posting Date: 10/04/2024

3Key Consulting is hiring! We are recruiting an Engineer Senior, Biotech Manufacturing and Process Equipment for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: Bachelor Engineering process mechanical degree and 5 years of process equipment experience

Job Description:
This engineering position supports manufacturing activities associated with cGMP equipment and facilities. The senior engineer works in partnership with the automation, maintenance, and manufacturing teams to develop and oversee the reliability of equipment while driving safety and quality compliance. The engineer will provide data to support business cases and long-term strategy.

The Senior Engineer role will provide direct engineering technical support as follows:

Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.
Be accountable for manufacturing equipment reliability
Suggest design modifications to address risks and design in quality and safety.
Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation

Top Must Have Skill Sets:

Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Direct knowledge of design and troubles hooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors,s chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

Day to Day Responsibilities:

Identify, support, and/or lead implementation of engineering based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order
Monitor systems to identify performance risks and implement risk reduction strategies
Providing trouble shooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action

Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience.

Why is the Position Open?
Supplement additional workload on team

Red Flags:
No prior process equipment experience

Interview Process:
Phone interview, Webex panel.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Process Engineer Senior, Drug Product Tech Transfer (JP13213) - Thousand Oaks, CA

Mon, 30 Sep 2024 15:27:27 GMT

Job Title: Process Engineer Senior, Drug Product Tech Transfer (JP13213)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Commercial Drug Product
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $44 - $50/Hours W2 with benefits
Posting Date: 09/30/2024
Notes: On site minimum 3 days per week.

3 Key Consulting is hiring! We are recruiting a Senior Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Technical Skills: Drug product fill finish processing, Holistic DP process knowledge.
Technical transfer, drug product manufacturing, regulatory filings.

Job Description:

The Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies.
Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in formulation, filtration, filling (vials/syringes/devices) and lyophilization of parenteral products.
Develops and characterizes drug product processes and transfers new technologies to commercial sterile fill/finish sites.
Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation.
Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
Leads and participates in global cross-functional teams working effectively in a highly matrixed team environment to influence and drive change, efficiency, and foster strong relationships.
Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine true root cause.
Authors and reviews guideline documents, technical protocols, reports, product impact assessments and regulatory submissions
Identifies and implements operational opportunities for current and new sterile operations.

Preferred Qualifications

Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specifically lyophilization would be an advantage.
Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.

Top Must Have Skill Sets:

Specifically looking for downstream purification experience
Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Day to Day Responsibilities:
Create and update manufacturing process documents, work with cross functional teams on product specific investigations, complete laboratory investigations and perform routine testing, monitor process data, imitate and lead meetings related to product initiatives

Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Why is the Position Open?
Supplement additional workload on team.
Red Flags:
No experience or short tenures with other jobs.
No experience owning and taking on projects.
Not able to come onsite 3 days onsite.

Interview Process:
Phone/ Webex, 2-3 rounds of interviews.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Planisware Consultant – Remote (JP13245) - Thousand Oaks, CA

Mon, 30 Sep 2024 12:07:35 GMT

Job Title: Planisware Consultant (Specialist Software Engineer) - Remote (JP13245)
Location: Thousand Oaks, CA. 91320
Business Unit: R&D Portfolio Strategy & Execution
Employment Type: Contract
Duration: 6 months with possible extension or conversion to FTE
Rate: Market Rate on W2 with benefits
Posting Date: 09/30/2024
Notes: On site or remote.

3 Key Consulting is hiring! We are recruiting a Specialist Software Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Key Responsibilities:

Support resource management team in various aspects of algorithm design, validation, output generation, quality review and troubleshooting
Design, develop, modify and support Planisware based applications using Planisware L1 configurations.
Design and develop solution for new requirements for a PPM Tool using Planisware based on discussion with business users
Troubleshoot and investigate issues with existing functionality in various reporting platforms
Support the quality review and acceptance testing for various reporting tools currently in development
Validate design with business requirements to ensure completeness of the solution.
Leverage best practices, disciplined approaches, and standards to solving technical problems.
Perform ongoing monitoring, debug, optimization, and refinement.
Apply standard methodologies and experience to build, develop and customize Planisware applications
Develop and maintain customizations for solution delivery utilizing Planisware and AWS platforms
Work closely with members of the Platform team, and cross-functionally with business and other IS partners using Agile principles
Work in a fast-paced changing environment, under pressure, balancing multiple assignments simultaneously

The experienced professional we seek is a skilled developer and problem solver with these qualifications:

5+ years of Planisware Experience (as either a Planisware user or consultant).
2+ years of Planisware related consulting/configuration experience.
Experience using, deploying, and/or supporting Planisware in a pharmaceutical or biotech company is desirable.
Exposure to Planisware V6/V7 - Expertise in development involving Planisware objects like PLW Script, Reports, Workflows, Macros, Cost Tables, Curves, Alerts, Locks, Formulas, Attributes, IEF, Web Service and other connectors
Excellent knowledge of Planisware version upgrades, maintenance pack upgrades, deployment objects/processes, monitoring/troubleshooting Planisware services
Ability to work in highly collaborative, cross-functional environments
Experience in Software Engineering and Development
Strong learning agility, ability to pick up new technologies
Solid experience working with agile methodology & DevOps (Jenkins, JIRA, GitHub) frameworks with successful experience working in a collaborative team environment
A thorough understanding of web services, data modeling, and enterprise application integration concepts.
Expertise with translating business requirements to technical requirements and recommend solutions

Top Must Have Skill Sets:

5+ years of Planisware Experience (as either a Planisware user or consultant).
2+ years of Planisware related consulting/configuration experience.
Experience using, deploying, and/or supporting Planisware in a pharmaceutical or biotech company is desirable.

Basic Qualifications:
Doctorate degree OR
Master’s degree and 2 years of Information Science experience OR
Bachelor’s degree and 4 years of Information Science experience

Employee Value Proposition:
Career growth
Opportunity
Unique industry experience

Why is the Position Open?
Supplement additional workload on team.

Interview Process:
Video Conference / Webex

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Process Development Engineer, upstream drug substance (JP13223) - Thousand Oaks, CA

Tue, 24 Sep 2024 17:53:00 GMT

Job Title: Process Development Engineer, Upstream Drug Substance (JP13223)
Location: Thousand Oaks, CA. 91320
Business Unit: Drug Product Development Manufacturing
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $38 - $42 / hr.
Posting Date: 9/24/2024
Notes: On site minimum 3 days per week. Specifically looking for upstream experience.

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Engineer will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.

* onsite a minimum of 3 days a week
**Must have biotech background/experience, plus must have cell culture and/or purification experience

Top Must Have Skill Sets:

Specifically looking for upstream purification experience
Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Day to Day Responsibilities:
Under guidance of senior staff, the Engineer performs the following:

Transfer purification drug substance processes and performs process improvements from the laboratory into the manufacturing facility
Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
Offer process validation support for late stage commercial processes
Provide routine process monitoring and troubleshooting
Execute data trending and statistical process analysis
Support technical direction for process related deviations, CAPAs and change controls
Identify and support process related operational excellence opportunities
Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Why is the Position Open?
Supplement additional workload on team.

Interview Process:
Phone/ Webex

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Process Development Engineer, Biopharma Drug Substance (JP13190) - Cambridge, MA

Thu, 19 Sep 2024 19:06:52 GMT

Job Title: Process Development Engineer, Biopharma Drug Substance (JP13190)
Location: Cambridge, MA 02138 (Hybrid or Remote)
Business Unit: Pilot Plant Operations
Employment Type: Contract
Duration: 6 months with likely extensions or conversion to perm
Rate: 38-42$/hours W2 with benefits
Posting Date: 09/20/2024
Target Start Date: 11/11/2024
Notes: Hybrid or Remote. EDT Standard Business hours

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Ideal Candidate: 3-4 years of industry experience, comfortable presentation. Biologics/ drug substance purification experience required (Chromatography, filtration, UFDF unit ops) Knowledge of purification processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a huge plus.

Job Description:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our Cambridge site. Providing strong process engineering/ technology transfer support of human therapeutic products in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.
The Engineer will apply cell culture and purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in both stainless and single-use formats. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic technology transfer.

Responsibilities include:
Under guidance of senior staff, the Engineer performs the following:

Transfer purification processes for drug substance manufacturing and translate process improvements from the laboratory into manufacturing facilities
Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
Assist in troubleshooting clinical and commercial runs
Execute data trending and statistical process analysis
Support technical direction for process-related deviations, CAPAs, and change controls
Identify and support process-related operational excellence opportunities
Represent process development and collaborates with other functions such as Manufacturing, Quality, and Regulatory

Top Must Have Skill Sets:

Purification/"downstream" laboratory (PD) or MFG experience with monoclonal antibodies, chromatography, filtration, UFDF, UF/DF, final fill, viral filtration, viral inactivation.
Technology Transfer/NPI experience is a plus.
PPQ experience is a plus

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Employee Value Proposition: Gain Biopharma experience.

Red Flags:
Initial duration of 6 months subject to longer extensions
Not looking for a recent graduate - the team is looking for a candidate who can join the team and make an impact.

Interview Process:
At least two per candidate (one by myself or with my manager, another with a couple more team members.) Phone/Teams is easiest.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Manufacturing Systems Engineer, Biopharma (JP13201) - New Albanay, OH

Tue, 17 Sep 2024 14:52:25 GMT

Job Title: Associate Manufacturing Systems Engineer, Biopharma (JP13204)
Location: New Albany, OH. 43054
Business Unit: Package Engineering & Maintenance
Employment Type: Contract
Duration: 12 Months with possible extensions or conversion to FTE
Rate: Open Market Rate
Posting Date: 09/17/2024

We are looking for an Associate Manufacturing Systems Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Important Notes:
The work schedule for this role will be a first shift (Monday through Friday, approximately 6:30 am to 3 pm) and then move to an off-shift schedule (6pm-6am). As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across the company’s 24-hour operations. These shift structures can be a great opportunity to better support individual work/life priorities in Non-Standard Shifts structure.

Pre-screening questions required
All candidates must have responses to the below pre-screening questions from the job seeker:

What PLCs and HMIs do you have experience with?
Please explain the process for taking a computer and going online with a plc step by step.
a. This will be a very long and detailed explanation
What versions of Rslogix and Studio have you worked with? Follow up question would be is Studio 5000 backwards compatible.
If you have Rockwell HMI experience, what versions you worked with and what programming did you do? Have you worked with SE or ME?
What vision systems have you worked with? If Cognex or Keyence please list off some of the tools you used to programming (Software, and programing tools)

PLC Experience
Electrical Troubleshooting
Technical Writing Capability
MUST BE SAFTEY ORIENTED
PLEASE NOTE SHIFT ABOVE

Preferred Qualifications:

Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
Other Automated Control Systems to be supported are: Siemens and Rockwell HMI’s, Cognex Vision System, Sensor and Systech Serialization
Experience with automation system hardware and software support, including installation
Excellent organizational, project management, problem solving and technical writing capability
Strong communication: verbal / written, collaboration, influencing and facilitation
MS Office: Word, Excel, Power Point

Day to Day Responsibilities:

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and company policies. Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&ID’s.
Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.

Basic Qualifications:
• High school diploma / GED and 6 years of Technical Engineering experience OR
• Associate’s degree and 4 years of Technical Engineering experience OR
• Bachelor’s degree

Employee Value Proposition: Unique industry experience

Red Flags:
Job hopping
Minimal work experience
Relocation required*** must be local
Cannot work shift requirement

Interview Process:
30 Minutes with hiring manager
3 person panel 1 hour

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Engineer, Packaging (JP13182) - Thousand Oaks, CA

Tue, 17 Sep 2024 13:57:29 GMT

Job Title: Associate Engineer, Packaging (JP13182)
Location: Thousand Oaks, CA. 91320
Business Unit: Secondary Packaging Engineering
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $30 - $35/hour W2
Posting Date: 9/17 /2024.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting an Associate Engineer, Packaging for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will be working in the engineering lab. They will have a bachelors in Packaging. We would consider new graduates, with 0 to 3 years general packaging/engineering experience if their education is tied to packaging.

In this role you will report into the Packaging Engineering group under Combination Products Operations (CPO) in Thousand Oaks, CA. This position will apply engineering principles to implement the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. Knowledge of primary and secondary packaging systems and material science is essential to the position. The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environments.

Top Must Have Skill Sets:
BS in Packaging or Packaging Engineering experience.

Day to Day Responsibilities:

Support for testing and evaluation leading to recommendation and selection of primary and secondary packaging materials
Familiarity with Material Testing standards, requirements and equipment is essential
Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components
Writing technical specifications, creating engineering drawings, and developing artwork

templates

Competent with AutoCAD, Illustrator, or similar software application to create, modify and approve engineering drawings
Support line trials and packaging validation activities prior to introduction of any new or change in components/processes
Collaborate with multi-functional teams (i.e. Quality, Device Engineering, Supply Chain, Artwork, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities

Basic Qualifications:
Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience

Preferred Qualifications:

2 years Packaging Engineering Experience outside of academia.
Nice to have: AutoCAD, Illustrator, or similar software application to create, modify and approve engineering drawings.

Red Flags:

Not able to commute to site.
No packaging education and/or packaging engineering experience
Mechanical Engineering, Chemical Engineering background with out any Packaging experience.

Why is the Position Open?
Supplement additional workload on team

Interview Process:

Two rounds of interviews Video conference.
Then a few 1:1 with hiring team.

Associate Manufacturing Systems Engineer, Biopharma (JP13162) - New Albanay, OH

Mon, 09 Sep 2024 15:05:31 GMT

Job Title: Associate Manufacturing Systems Engineer, Biopharma (JP13162)
Location: New Albany, OH. 43054
Business Unit: Pkg Engineering & Maintenance
Employment Type: Contract
Duration: 6+ months with possible extensions or conversion to FTE
Rate: Open Market Rate
Posting Date: 09/09/2024

We are looking for an Associate Manufacturing Systems Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Important Notes:
The work schedule for this role will be a first shift (Monday through Friday, approximately 6:30 am to 3 pm) and then move to an off-shift schedule (6pm-6am). As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across the company’s 24-hour operations. These shift structures can be a great opportunity to better support individual work/life priorities in Non-Standard Shifts structure.

Pre-screening questions required
All candidates must have responses to the below pre-screening questions from the job seeker:

What PLCs and HMIs do you have experience with?
Please explain the process for taking a computer and going online with a plc step by step.
a. This will be a very long and detailed explanation
What versions of Rslogix and Studio have you worked with? Follow up question would be is Studio 5000 backwards compatible.
If you have Rockwell HMI experience, what versions you worked with and what programming did you do? Have you worked with SE or ME?
What vision systems have you worked with? If Cognex or Keyence please list off some of the tools you used to programming (Software, and programing tools)

PLC Experience
Electrical Troubleshooting
Technical Writing Capability
MUST BE SAFTEY ORIENTED
PLEASE NOTE SHIFT ABOVE

Preferred Qualifications:

Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
Other Automated Control Systems to be supported are: Siemens and Rockwell HMI’s, Cognex Vision System, Sensor and Systech Serialization
Experience with automation system hardware and software support, including installation
Excellent organizational, project management, problem solving and technical writing capability
Strong communication: verbal / written, collaboration, influencing and facilitation
MS Office: Word, Excel, Power Point

Day to Day Responsibilities:

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and company policies. Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&ID’s.
Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.

Engineer, Packaging Process Equipment (JP13131) - New Albany, OH

Thu, 05 Sep 2024 13:04:13 GMT

Job Title: Engineer, Packaging Process Equipment (JP13131)
Location: New Albany, OH
Business Unit: Final Product Technologies / Combination Product Medical Device
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $33 - $37/hour
Posting Date: 10/26/2024
Note: This role will mostly support different working shifts .

3 Key Consulting is hiring! We are recruiting an Engineer for consulting engagement with our direct client, a leading global biotechnology company.

Ideal candidate: 2+ years of working experience. Knowledge of data analysis, CGMP documentation, and packaging equipment.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.

Schedule:
This position should not exceed 40 hours a week but some overtime may be needed occasionally. On this role is required working hours flexibility as per Projects need. Extended and second shift will be required for period of time. Mon-Friday with possible occasional weekend shifts. (Candidates will be able to volunteer for weekend shifts). 10% travel may be required.

Top Must Have Skill Sets:

Experience in Pharmaceutical Packaging Operations.
Commissioning, Characterization and Validation Experience
Protocols Execution and reports generation

Red Flags:
Ideal Candidate: 2+ years of Pharmaceutical Packaging working experience. Knowledge of data analysis, CGMP documentation, and Packaging Equipment Validation.

Interview Process:
First stage phone interview after screening resumes.
Second stage phone interviews with colleagues (1-3).

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Senior Human Factors Engineer, Instructions For Use/Medical Device – Remote (JP13164) - Thousand Oaks, CA

Thu, 05 Sep 2024 12:42:15 GMT

Job Title: Senior Human Factors Engineer, Senior Human Factors Engineer, Instructions For Use/Medical Device – Remote (JP13164) – Remote (JP13164)
Location: Thousand Oaks, CA. 91320 (Remote Flexible)
Business Unit: Combination Product Excellence
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: Open – Market Rate W2
Posting Date: 9/5/2024.
Notes: Only qualified candidates need apply. Must have online portfolio

3 Key Consulting is hiring! We are recruiting a Senior Human Factors Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
To be considered, candidates MUST supply an online portfolio.

NOTE: This is expected to be a contract position within our client’s Human Factors and Usability Engineering group, working 40 hours/week. The position is for 1 year and may be renewed at the end of that period. This position can be remote or in-person at the client’s Thousand Oaks, CA headquarters. If the candidate is within commuting distance of Thousand Oaks, they will be expected to work on-site most/all hours. There is no relocation for this position.

Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination products/drug delivery devices. IFU creation includes copy, layout, and line-art illustrations.
Develops both low- (simple sketch) and high-fidelity digital samples of instructional materials intended for print.
Manages instruction design projects, working closely with other designers, HF engineers, and other related functions.
Supports usability studies with quick turn-around during iterative studies in a design-test-refine-test model.
Balances design thinking with regulatory requirements during development of instructional materials.
Develops instructions for new projects by understanding user needs with HFE partners and applying platform guidelines to create approachable, useful, and effective instructions for users who may be new to the therapy and drug administration.
Maintains history records to capture rationale for changes over the development of the instructions.
Supports process improvement initiatives, including: defining and documenting current procedures within the group and working with cross-functional partners to improve and document labeling across upstream and downstream functions.

Top Must Have Skill Sets:

Minimum 5-10 years of instruction design experience including IFUs, including strong proficiency in rapid sketch illustration, digital line-art illustration, and image (photo) editing. Proficient in Adobe Creative Suite (InDesign, Illustrator, Photoshop), and strong knowledge of InDesign paragraph and character styles. Understands the application of structure and grids for the development of platforms to ensure consistency in output and efficiency in process during instruction creation.
Minimum 3-5 years managing design projects and/or teams.
Medical, healthcare, medical devices and/or pharmaceuticals background.
Must be punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects.
If remote, must have experience working remotely from others in team.
High-level attention to detail and accuracy in reducing errors in work deliverables.

Day to Day Responsibilities:

Create and update IFUs, reference guides, and carton artwork content and graphics (layout and illustrations) for new and existing medical device/combination products to ensure accuracy and compliance with applicable regulations, industry standards, and company requirements.
Develop instruction design strategies for individual projects that align with department and corporate instruction platforms. Manage individual projects, representing the Instruction Design group, by coordinating with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements and execute on plans.
Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate.
Maintain change history of instruction materials during their development.
Produce low (quick sketch) to high (refined digital files) fidelity prototypes of IFUs, reference guides, and carton artwork for usability studies. High fidelity prototypes may require plotting, trimming, folding, binding, laminating, and constructing structural cartons.
Provide expertise and guidance to Human Factors engineering partners and other cross-functional partners with content generation, illustrations, layout, and formatting of instruction materials.
Support process improvement programs and documentation of cross-functional processes.
Manage junior staff and/or oversee external vendors to execute design work.
Troubleshoot relatively complex problems and issues.

Red Flags:

Only academic experience
Past experience exclusively in marketing, branding, logos, websites without any experience writing instructions for regulated products
Only junior-level experience designing; we need senior-level experience and thinking for this role. Requires experience managing design projects and working with multiple stakeholders
Text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals, defense user manuals)

Why is the Position Open?

Interview Process:
Video conference

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, Biopharma Upstream cell culture or downstream purification (JP13132) - Cambridge, MA

Thu, 29 Aug 2024 15:00:45 GMT

Job Title: Engineer, Biopharma Upstream cell culture or downstream purification (JP13132)
Location: Cambridge, MA 02138
Business Unit: Pilot Plant
Employment Type: Contract
Duration: 1+ years with possible extensions or conversion to FTE
Rate: $37 - $41
Posting Date: 08/29/2024
Notes: Onsite local candidate only

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: Previous biotech / pharma experience. Experience working with equipment. Upstream cell culture or downstream purification experience. Provide equipment support.

Nice to have: Chemical Engineering B.S preferred. Instrumentation background, preventative maintenance, automation background (DeltaV or Finesse controllers), and process monitoring or trending experience. Bioreactors, Chromatography
Job Description:
Responsibilities include:

Perform the system owner role for assigned systems to ensure equipment reliability and technology development initiatives.
Develop and maintain process control automation solution for bench top Finesse and DeltaV Controllers systems in Next Generation Lab
Coordinating projects for equipment modification/improvement
Data trend analysis of the system and equipment used for technology development to identify and proactively manage performance trends.
Ensuring the preventive maintenance schedule for the systems is successfully implemented.
Create a critical spare parts list for the systems/equipment and maintain appropriate levels of spares.
Troubleshooting of performance trends and equipment reliability.
Support of new product introductions and implementation of new equipment/technology.
Support of continuous improvement project monitoring effectiveness of implemented projects.
Initiating review and approval of changes to operating procedures and EHS change control process relating to the system.
Identify and implement engineering-based improvements or upgrades to process equipment, including identification of design requirements, options analysis, design, installation, startup and qualification of equipment.
Designing, executing, implementing and leading engineering or process projects
Working in a collaborative manner with various functions and contributing to investigations

Top Must Have Skill Sets:
- Organized project work
- Proactive troubleshooting
- Collaborative project experience

Day to Day Responsibilities:
- Ensure preventative maintenance is performed on equipment
- Coordinate and organize project work
- Support continuous improvement projects

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Why is the Position Open?
New position.
Employee Value Proposition: Gain Biopharma experience. This team is willing to grow and develop this person

Red Flags:
Low GPA. Non-scientific major / experience.
Candidates must be willing to grow and develop.

Interview Process:
Phone screen followed by in-person or video panel interviews.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Engineer, GMP Physical Test Methods - Hybrid (JP13129) - Thousand Oaks, CA

Fri, 23 Aug 2024 14:56:20 GMT

Job Title: Engineer, GMP Physical Test Methods - Hybrid (JP13129)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit:
Employment Type: Contract
Duration: 18+ months with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 8/23/2024.
Notes: Only qualified candidates need apply. Must be local to Thousand Oaks, CA will work hybrid (typically onsite about twice per week sometimes more)

3 Key Consulting is hiring! We are recruiting an Engineer, GMP Physical Test Methods for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
The Engineer, in Physical Methods, is responsible for engineering activities required for the development /
qualification / validation and transfer of physical GMP test methods for combination products, devices,
primary containers, and secondary packaging parts. The Engineer shall have the ability to work on
multiple projects at one time that may involve changes or new product, processes, tooling or equipment
introduction to improve quality and reliability and reduce cost. Phases of projects include: developing
combination product test methods, providing key experienced support for qualification, validation, transfer,
and life cycle support of methods for manufacturing, new product introduction, training, and production
support.

Top Must Have Skill Sets:

Technical writing experience
Strong communication skills
CAD experience (modeling, designing)
Experience managing their own workload independently

Day to Day Responsibilities:

Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
Provide experienced support for investigations as well as new process development required to improve manufacturing operations.
Coordinate test method development and delivery with selected contractors.
Ensure that qualification parameters are met for product assembly requirements.
Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
Generate procedures necessary to support department and new process equipment.
Provide experienced training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).
Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
Generate/author and be responsible for the Test Method documents.
Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
Perform other duties as required by the Group Manager
Align with the requirements, responsibilities, and authority as required
Maintains integrated timelines collecting appropriate multi-functional details and work which are aligned with the functional and project work
Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
Networks with manufacturing, quality and regulatory organizations both internal and external to client
Drives the multi-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership
Collaborates with other functional leaders to ensure project success, momentum and commitment
Proactively identifies issues and/or risks and develops mitigation options to resolve or increase efficiently
Integrates partner/vendor timelines with client timelines as appropriate

M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
Excellent written and verbal communication skills
Ability to work in a highly matrixed team environment
2 years of experience in the biotechnology/pharmaceutical industry
2 years of experience in equipment, method, and mechanical design
Technical writing experience
Experience with SolidWorks (or other 3D-CAD software)
Experience with combination products and regulatory requirements
Experience applying Minitab (or other statistical software packages)

Why is the Position Open?
Supplement additional workload on team

Interview Process:

Phone screen
Video conference

Senior Engineer, MES PAS-X Software - Biopharma – Hybrid (JP13127) - Thousand Oaks, CA

Thu, 22 Aug 2024 10:47:45 GMT

Job Title: Senior Engineer, MES PAS-X Software - Biopharma – Hybrid (JP13127)
Location: Thousand Oaks, CA. 91320
Business Unit: NPI/EBR Support
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $70 - $80/hour DOE with benefits
Posting Date: 10/22/2024.
Note: Local preferred but can be remote

3 Key Consulting is hiring! We are recruiting a Senior Software Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Support Drug Substance Supply organization. This is a manufacturing support role responsible for the generation of electronic documentation, for tracking of NPI/EBR metrics, and for communication between the GMP operations teams and the process development scientific groups. This position will be focused on Electronic Batch Records for Drug Substance manufacturing.

Job scope and responsibilities:

Manufacturing Electronic Batch Record (EBR) generation using PAS-X (Korber)
Validation of new Electronic Batch Records (Application Lifecycle Management)
Assisting in implementation of new MES functionality
Develop standard work and business practices for new MES functionality
Contributing to Lean Transformation through recording NPI/EBR metrics and application of continuous improvement tools.
Participate and contributing to projects to introducing new products and/or advancement of new manufacturing technologies into the plant.

Top Must Have Skill Sets:
MUST have strong PAS-X software experience for electronic batch records with detailed understanding of editing and validation
Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing

Basic Qualifications:
Doctorate Degree OR Master Degree and 3 years of Engineering experience OR Bachelor Degree and 5 years of Engineering experience OR Associate degree and10 years of Engineering experience

Preferred Qualifications:

Experience with PAS X (Korber) software for electronic batch records with detailed understanding of editing and validation
Strong knowledge of PAS-X integration with external programs (SAP, PI, and DeltaV)
Strong operations knowledge of drug substance manufacturing and a broad understanding of related disciplinary areas in bioprocessing
Demonstrated ability to work in a team
Degree in Chemical Engineering, Biochemistry, Chemistry or Biology or Computer Science with experience in biotechnology

Senior Associate Facilities, Biopharma (JP13056) - Thousand Oaks, CA

Mon, 19 Aug 2024 10:44:36 GMT

Job Title: Senior Associate Facilities, Biopharma (JP13056)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities and Engineering Drug Substance Supply group.
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: Open Market Rate W2
Posting Date: 8/19/2024.
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring! We are recruiting a Senior Associate, Facilities for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
We are looking for a Sr. Associate Facilities to provide maintenance leadership and technical expertise in support of facility equipment/systems, utility systems, and/or production suites, ensures systems operate within designed parameters. Area of responsibility may consist of multiple facilities, disciplines, or clients. All work to be completed to assure minimal impact to production while complying with all safety / cGMP guidelines and client procedures.

Top Must Have Skill Sets:

Technical Skills Regarding Facilities Engineering
Great Communication Skills
Teamwork
Resumes need to be thorough and carry a strong level of documentation of previous experience and how its relatable to this role and it's requirements !

Day to Day Responsibilities:

Directing/planning/delegating of tasks to personnel in daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner. This includes, but is not limited to, maintenance and emergency repair of all production related utilities and facility equipment that support GMP production:
- HVAC, HEPA certifications, and pressure cascades, water purification systems, plant and clean steam, chillers and clean gas systems.

Additionally, the staff will need to understand room classification and gowning requirements. Alarms and associated subject matter expertise will be provided to triage events impact to quality or safety. Fundamental control system strategy and logic will need to be understood to troubleshoot and provide data trends from EMS/BMS/USC systems.

Create, edit, or obsolete training with associated equipment systems and evaluate staff proficiency to qualification records.
Development and maintain the current repair job plans and spares inventory control for associated equipment
Interact with various support teams for integrated contracted partners for calibration support and outside vendors that provide contracted maintenance
Assure quality and safety change control procedures are followed and changes are approved prior to execution and purchases being approved.
Work to be completed in accordance with CFRs, cGMPs, SOPs and client policies
Participate in On-Call rotations for after-hours facility and Manufacturing support and may work outside of established shift hours upon short notice

Basic Qualifications:
Master’s degree OR Bachelor’s degree and 2 years of maintenance experience OR Associate’s degree and 6 years of maintenance experience OR High school diploma / GED and 8 years of maintenance experience

Preferred Qualifications:

2 year technical/AA/AS degree in building maintenance, Mechanical maintenance, Plant engineering or related technical discipline.
7+ years combined education and experience with 4+ years in an FDA (GMP) or comparable regulated nvironment
Experience with RCA facilitation and participation
Experience with RCM, TPM, or other reliability centered concepts
Experience with installation, troubleshooting, maintenance, repair and testing of HVAC, laboratory and utilities equipment
Advanced Knowledge of pneumatic, mechanical, and hydraulic fundamentals as well as advanced skills in the use of power and hand tools in the building trades such as carpentry, plumbing, and electrical
Effective oral and written communication skills
Possess a high mathematical understanding, excellent reading skills along with intermediate to advanced computer and typing skills

Red Flags:

Lack of Technical Details
Poor Communication and Teamwork
Lack of engagement

Why is the Position Open?
Supplement additional workload on team

Interview Process:

Interview Process:
WebEx

Engineer, Drug Product Manufacturing / Processing - Hybrid (JP13084) - Thousand Oaks, CA

Wed, 14 Aug 2024 12:07:52 GMT

Job Title: Engineer, Drug Product Manufacturing / Processing - Hybrid (JP13084)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Commercial Drug Product Processing Group
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 8/14/2024.
Notes: Only qualified candidates need apply. MUST BE LOCAL to Thousand Oaks, CA. Consultant should be a Flexible Commuter. Consultant may be required to be onsite as needed based on business needs and can expect to be onsite on a weekly basis.

3 Key Consulting is hiring! We are recruiting an Engineer, Drug Product Manufacturing / Processing for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at our client in Thousand Oaks, CA. and which includes various production lines.

The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects.
The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff.
The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of products.
The candidate will assist in establishing the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Top Must Have Skill Sets:

Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Strong cross functional team player with good communication skills (oral and written)

Day to Day Responsibilities:

Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
Support development and maintenance of technology transfer tools (clinical and commercial)
Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
Development of digital tools and models by leveraging data analytics and programming skills
Support at scale characterization and/or process validation runs as person in plant

Basic Qualifications:

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
This is a drug product processing group any familiarity with this (unit operations in scope of drug product would be very helpful!)
Strong interpersonal skills, must be motivated to learn, willing and comfortable with asking questions when they don't understand something and taking direction (rather than tasking based on assumption)
Strong ability to think critically build relationships
Able to work in a fast paced nuanced environment
Taking initiative

Preferred Qualifications:

B.S. in engineering discipline with 1‒3 years’ experience or M.S. in engineering discipline with 0‒2 years’ experience
Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
Knowledge of and hands-on experience with various drug product technologies
Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
Excellent project management skills and ability to escalate relevant issues to project lead and line-management
Strong cross functional team player with good communication skills (oral and written)
Ability to work independently and as part of a team with internal and external partners
Good computer and organizational skills with strong attention to detail
Self-motivated with a positive attitude

Red Flags:

Experience on resume not reflective of actual work experience
Not being able to take direct feedback and apply to task assigned
Not having open communication and asking questions when there isn’t an understanding of process or task

Why is the Position Open?
Supplement additional workload on team

Interview Process: Phone first then virtual interview to follow.

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

Associate Manufacturing Systems Engineer, Biopharma (JP13088) - New Albanay, OH

Sat, 10 Aug 2024 13:47:01 GMT

Job Title: Associate Manufacturing Systems Engineer, Biopharma (JP13088)
Location: New Albany, OH. 43054
Business Unit: Pkg Engineering & Maintenance
Employment Type: Contract
Duration: 12 Months with possible extensions or conversion to FTE
Rate: Open Market Rate
Posting Date: 08/10/2024

We are looking for an Associate Manufacturing Systems Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Important Notes:
The work schedule for this role will be a first shift (Monday through Friday, approximately 6:30 am to 3 pm) and then move to an off-shift schedule (6pm-6am). As the facility moves into operation, the successful incumbent will be expected to join a shift team structure working to support coverage across the company’s 24-hour operations. These shift structures can be a great opportunity to better support individual work/life priorities in Non-Standard Shifts structure.

Pre-screening questions required
All candidates must have responses to the below pre-screening questions from the job seeker:

What PLCs and HMIs do you have experience with?
Please explain the process for taking a computer and going online with a plc step by step.
a. This will be a very long and detailed explanation
What versions of Rslogix and Studio have you worked with? Follow up question would be is Studio 5000 backwards compatible.
If you have Rockwell HMI experience, what versions you worked with and what programming did you do? Have you worked with SE or ME?
What vision systems have you worked with? If Cognex or Keyence please list off some of the tools you used to programming (Software, and programing tools)

PLC Experience
Electrical Troubleshooting
Technical Writing Capability
MUST BE SAFTEY ORIENTED
PLEASE NOTE SHIFT ABOVE

Preferred Qualifications:

Educational background in Mechatronics, Computer Science, Electronic Engineering Technology, Computer Engineering or Electrical Engineering
Understanding in PLC, Computer Serialization, Packaging Equipment, Inspection System
SCADA/PLC Control System experience in Pharmaceutical, Medical Device or Biotechnology Industry
Other Automated Control Systems to be supported are: Siemens and Rockwell HMI’s, Cognex Vision System, Sensor and Systech Serialization
Experience with automation system hardware and software support, including installation
Excellent organizational, project management, problem solving and technical writing capability
Strong communication: verbal / written, collaboration, influencing and facilitation
MS Office: Word, Excel, Power Point

Day to Day Responsibilities:

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and company policies. Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for the equipment/systems the team.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program, trouble shoot and repair equipment/system failures.
Interpret and review utility, process system/ equipment, plumbing, ductwork plans, architectural, and HVAC P&ID’s.
Support Operations in Non-Standard shifts that includes weekends and/or holidays as determined by business.

Engineer, Combination Device MS&T (JP13077t) - Thousand Oaks, CA

Fri, 09 Aug 2024 14:32:43 GMT

Job Title: Engineer, Combination Device MS&T (JP13077t)
Location: Thousand Oaks, CA. 91320
Business Unit: Physical Methods Development Modelling and Emerging Methods
Employment Type: Contract
Duration: 2+ years with likely extensions and/or conversion to hire.
Rate: $38 - $42/hour W2
Posting Date: 7/24/2024.
Notes: Only qualified candidates need apply. Can be within commutable distance of client’s Thousand Oaks, CA. facility.

3 Key Consulting is hiring! We are recruiting an Engineer, Combination Device MS&T for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have:

3 YOE in field desired with bachelors.
Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired.
Mathematical background fundamentals of statistics.
Useful to have exposure to test method development, CAD design, SolidWorks, mechanical modeling.
Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.
The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions
This may include, but is not limited to, the following:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data
Network with manufacturing and quality organizations internal to client.
Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
Monitoring technological developments in the field & evaluation of new technologies

Top Must Have Skill Sets:

Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics
Ability to manage multiple, competing priorities simultaneously

Day to Day Responsibilities:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Run Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.

Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:

Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project

Why is the Position Open?
Supplement additional workload on team

Interview Process:

Phone screen.
Panel Interview.

Engineer, Combination Device MS&T (JP13077c) - Cambridge, MA

Fri, 09 Aug 2024 14:30:28 GMT

Job Title: Engineer, Combination Device MS&T (JP13077c)
Location: Cambridge, MA. 02138
Business Unit: Physical Methods Development Modelling and Emerging Methods
Employment Type: Contract
Duration: 2+ years with likely extensions and/or conversion to hire.
Rate: $38 - $42/hour W2
Posting Date: 7/24/2024.
Notes: Only qualified candidates need apply. Can be within commutable distance of client’s Cambridge, MA. facility.

3 Key Consulting is hiring! We are recruiting an Engineer, Combination Device MS&T for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have:

3 YOE in field desired with bachelors.
Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired.
Mathematical background fundamentals of statistics.
Useful to have exposure to test method development, CAD design, SolidWorks, mechanical modeling.
Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data
Network with manufacturing and quality organizations internal to client.
Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
Monitoring technological developments in the field & evaluation of new technologies

Top Must Have Skill Sets:

Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics
Ability to manage multiple, competing priorities simultaneously

Day to Day Responsibilities:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Run Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.

Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ

Preferred Traits:

Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project

Why is the Position Open?
Supplement additional workload on team

Interview Process:

Phone screen.
Panel Interview.

Engineer, Process Development hybrid (JP13072) - Thousand Oaks, CA

Tue, 06 Aug 2024 16:51:33 GMT

Job Title: Engineer, Process Development hybrid (JP13072)
Location: Thousand Oaks, CA. 91320 (hybrid)
Business Unit: Drug Substance Technology and Engineering
Employment Type: Contract
Duration: 1+ year(s) with likely extensions and/or conversion to permanent.
Rate: $38 - $42/hour W2
Posting Date: 8/6/2024.
Notes: Only qualified candidates need apply. Onsite 3-4 days a week at Thousand Oaks, CA. campus. Standard business hours with some after hour support. On site minimum 3 days per week. Must have biotech background/experience, plus must have cell culture and/or purification experience

3 Key Consulting is hiring! We are recruiting a Engineer, Process Development for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Our ideal candidate will have 2-4 years of relevant experience working in drug and animal cells; and strong process knowledge. Experience purifying cells (biologics purifications), drug substance GMP manufacturing.

We are seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Thousand Oaks, CA. facility. Providing process engineering support for human therapeutic products in clinical development through commercial production, our client’s mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Engineer will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.

Top Must Have Skill Sets:

Drug substance biologics process development, pilot plant or manufacturing technical support
Purification of monoclonal antibodies
Experience in GMP environment (preferably in drug substance)

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Must have biotech background/experience, plus must have cell culture and/or purification experience

Why is the Position Open?
Backfill.

Red Flags:

Short duration stints in prior jobs
Resume does not accurately reflect true experience
Cultural fit - manager described the team as easy going, growth motivated, organized, and respectful.
Too senior or experienced for the position (not looking for more than 5+ years of experience)

Interview Process:

Phone interview
Panel interview with 3-4 individuals in the team (with manager and director)

Engineer, Biopharma Medical Device Solid Modeling/Testing - Hybrid (JP13070) - Thousand Oaks, CA

Tue, 06 Aug 2024 13:37:58 GMT

Job Title: Engineer, Biopharma Container Closure Solid Modeling/Testing - Hybrid (JP13070)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Business Unit: Physical Methods Development, Modelling and Emerging Methods
Employment Type: Contract
Duration: 18 months with possible extension or conversion to FTE
Rate: 36 - $42/hr with benefits
Posting Date: 2/7/2024.
Notes: Will be onsite at least 2x/ week. Candidate must be within commutable distance and must be able to come on site 5 days a week if needed.

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for container closure integrity testing (CCIT) related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. Assist with project definition by performing engineering studies and assessment for CCIT system installations. Perform field evaluations of existing systems and provide engineering design recommendations and support development of CCIT technologies.

Biopharma or Biotech experience and/or Equipment Validation experience within another industry. Position is split between lab and office.

Equipment qualification- Equipment validation is a highly desired skillset. Will be working with other associates on testing and conducting testing themselves.

Day to day will include supporting development of technical documentation related to CCI testing, execution of protocols to support development, writing of technical documentation to support findings and results.

Heavy on documentation role

Top Must Have Skill Sets:
Solid modeling
Technical Writing
Working in a team

Day to Day Responsibilities:
Documentation writing (procedures, technical assessments, engineering drawings, etc)
Solid modeling (fixture development)
Meetings
Testing

Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Why is the Position Open?
Supplement additional workload on team.

Red Flags:
Less than a bachelors degree
A non-STEM bachelors degree
No work experience (internship okay)

Interview Process:
Initial phone call
Panel interview (2-3 people on call)

We invite qualified candidates to send your resume torecruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.