Job Openings | 3 Key Consulting

Engineer – Biotech Medical Device (Lifecycle Management, Design Controls, Documentation) - (JP15650) - Thousand Oaks, CA

Tue, 04 Aug 2026 14:39:40 GMT

Job Title: Engineer – Biotech Medical Device (Lifecycle Management, Design Controls, Documentation) - (JP15650)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Mechanical Autoinjectors Platform
Duration: 16 months with likely extensions and/or conversion to permanent
Posting Date: 08/04/2026
Pay Rate: $40 - $46/hour W2 with benefits
Notes: Must be local - hybrid work schedule 3 onsite, 2 WFH - Urgent role to fill.

3 Key Consulting is hiring a Medical Device Engineer – Combination Products (Lifecycle Management, Design Control, Documentation) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Engineer will support the lifecycle management (LCM) of commercial combination products, providing technical engineering support throughout the product lifecycle to ensure continued product quality, reliability, and compliance. This role partners with cross-functional teams including Manufacturing, Quality, Design Engineering, Reliability, Regulatory, and Supply Chain to investigate product performance, support product improvements, maintain design documentation, and execute Design Controls activities.
The successful candidate will apply engineering fundamentals, analytical problem-solving, and technical documentation skills to support commercial products through forensic investigations, trend analysis, engineering change management, and continuous improvement initiatives. The Engineer I will also support cross-functional initiatives to sustain commercial combination products through engineering investigations, risk assessments, Design Controls, and continuous product and process improvements.
Top Must Have Skill Sets:
1) Device Design Controls understanding and associated experience
2) Theoretical or practical experience in device failure more root cause analysis
3) Good documentation skills

Key Responsibilities

Support lifecycle management activities for commercial combination products throughout their commercial lifecycle.
Perform forensic evaluation of returned, retained, and engineering samples to support technical investigations.
Assemble and disassemble combination product samples for engineering analysis, troubleshooting, and failure investigations.
Lead and support structured root cause investigations using sound engineering methodologies and cross-functional collaboration.
Manage technical trend investigations by evaluating manufacturing, laboratory, complaint, and engineering data to identify product or process trends and recommend appropriate actions.
Support engineering investigations associated with deviations, CAPAs, nonconformances, and product complaints to identify root causes and implement effective corrective and preventive actions.
Support engineering change control activities, including technical assessments, risk evaluations, documentation updates, and implementation of product and process changes.
Support product risk management activities, including risk assessments, Design FMEA (dFMEA), Process FMEA (pFMEA), and evaluation of design or process changes throughout the commercial lifecycle.
Support Design Controls activities across the product lifecycle, including feasibility, characterization, verification, validation, design transfer, and post-market engineering support.
Support development, qualification, execution, and continuous improvement of engineering test methods used for characterization, verification, validation, and commercial lifecycle investigations.
Support development and maintenance of engineering specifications, test methods, and technical standards for commercial combination products.
Author, review, and maintain technical documentation including engineering assessments, protocols, reports, specifications, test methods, risk assessments, and Design Controls deliverables.
Support the development, maintenance, and continuous improvement of Design History Files (DHF) and Device Master Records (DMR).
Collaborate with Manufacturing, Quality, Regulatory, and Operations teams to support commercial production, technical investigations, product improvements, and continuous improvement initiatives.
Apply engineering principles and statistical methods to analyze engineering, manufacturing, laboratory, and complaint data to support technical decision making, product performance assessments, and issue resolution.
Support product complaint investigations and engineering assessments to identify potential failure mechanisms and corrective actions.
Ensure engineering documentation is complete, accurate, and compliant with applicable quality system requirements and company procedures.
Support multiple commercial programs while effectively managing priorities and project timelines.

Preferred Qualifications and Experience
Experience in one or more of the following areas:

Combination products or medical device development, commercialization, or lifecycle management.
Lifecycle management (LCM) of commercial medical devices or combination products.
Mechanical system design, testing, and analysis.
Mechanical failure analysis and root cause investigations.
Product complaint investigations and forensic engineering analysis.
Experience performing computed tomography (CT) scanning, X-ray imaging, or comparable non-destructive forensic analysis techniques for medical devices or plastic injection molded components.
Experience performing forensic analysis of plastic injection molded components, including dimensional, cosmetic, structural, or material-related investigations to support root cause analysis and product performance assessments.
Assembly and disassembly of medical devices for engineering evaluation.
Engineering change control and product lifecycle documentation.
Experience supporting deviations, CAPAs, nonconformances, and engineering investigations within a regulated quality system.
Design Controls activities including feasibility, characterization, verification, validation, design transfer, and post-market support.
Development and maintenance of Design History Files (DHF) and Device Master Records (DMR).
Experience participating in Design FMEA (dFMEA), Process FMEA (pFMEA), and engineering risk assessments.
Risk management in accordance with FDA Quality System Regulation, ISO 13485, and ISO 14971 principles.
Statistical analysis and interpretation of engineering, manufacturing, laboratory, or complaint data.
Experience using statistical software such as Minitab, JMP, or equivalent for engineering and data analysis.
Familiarity with Design of Experiments (DOE), Statistical Process Control (SPC), process capability analysis, and engineering statistics.
Trend analysis using manufacturing, laboratory, or complaint data to identify product or process performance trends.
Technical documentation, engineering reports, protocols, and scientific writing.
Laboratory instrumentation and test equipment.
Mechanical testing and characterization of medical devices or plastic injection molded components.
Test method development, verification, validation, and qualification.
Prototype fabrication and mechanical evaluation.
Test fixture design and development.
SolidWorks or equivalent 3D CAD software.
Ability to interpret engineering drawings, geometric dimensioning and tolerancing (GD&T), specifications, and technical standards.
Cross-functional collaboration with Manufacturing, Quality, Regulatory, Reliability, and Design Engineering teams.

Basic Skills

Strong analytical, troubleshooting, and problem-solving skills.
Ability to perform structured root cause investigations using sound engineering methodologies.
Excellent written and verbal communication skills.
Strong technical writing skills for engineering documentation, reports, and Design Controls deliverables.
Ability to analyze complex technical data and communicate engineering conclusions effectively.
Ability to read, interpret, and apply engineering drawings, specifications, technical procedures, and applicable quality system requirements.
Strong organizational skills with the ability to manage multiple assignments and priorities in a fast-paced, regulated environment.
Ability to work independently while collaborating effectively within cross-functional teams.
High attention to detail and commitment to quality.
Comfortable working in laboratory, manufacturing, and office environments while following applicable safety procedures.

Work Environment
This position includes laboratory, manufacturing, and office-based activities supporting commercial combination products. Responsibilities include handling and evaluating drug delivery devices, performing engineering evaluations, operating laboratory equipment, and supporting investigations involving prefilled syringe-based combination products in accordance with applicable safety procedures.
This is a contingent worker position supporting engineering activities within company Combination Product Engineering organization.

Why is the Position Open?
Supplement additional workload on team

Day to Day Responsibilities:
Ability to support RCAs from rejected units from assembly site sites. Maintenance of trend evaluations across the LCM network and ability to support LCM and some development documentation related to design controls such as verification plans and DHF maintenance.

Value Proposition: Unique industry opportunity, career growth, experience

Red Flags:

Lack of experience in the design controls process.
No ability to perform testing at ATO or AMA site
Minimal to no experience or understanding of combination products or drug delivery devices.
Bad communication skills.
Uncomfortable with a hybrid working environment.

Interview process:

Interviews to be begin ASAP
Two virtual interviews
Final 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.

Automation Engineer (DCS/DeltaV) - Bioprocess Manufacturing Support - (JP15648) - Thousand Oaks, CA

Thu, 30 Jul 2026 14:58:37 GMT

Job Title: Automation Engineer (DCS/DeltaV) - Bioprocess Manufacturing Support - (JP15648)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Advanced Technology & Automation
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 07/30/2026
Pay Rate: $40 - $46/hour W2 with benefits
Notes: Only qualified candidates need apply. Monday - Friday - 8am - 5:00pm. Must be willing to be on call - After hours support once every 6 weeks (Manufacturing calls that come in, resolve any issues that come up) - 1 call per week (call is 2 hours)

3 Key Consulting is hiring an Senior DeltaV/DCS Automation Engineer – Bioprocess Manufacturing Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our client is seeking an External Automation Engineer based in Thousand Oaks, California to augment their MCS F&E Automation team. This role will support ongoing biological processes by updating, maintaining, and improving DeltaV automation systems, and providing critical site support. The successful candidate must exhibit sound analytical thinking and problem-solving skills, exemplary communication and collaboration, and operational excellence. A proven ability to work in cross-functional teams is critical for this role.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Strong control system automation background in design, installation, programming, and validation of automated processes.
Ability to read and follow electrical and P&ID drawings.
Must be independent, self-motivated, organized, and able to multi-task.

Day to Day Responsibilities:

Develop and support process control applications via Distributed Control Systems (DCS), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA), and Programmable Logic Controllers (PLC).
Collaborate with scientific and operational staff to help translate process requirements into automation and engineering design.
Participate in technical root cause analysis, incident investigations, and troubleshooting on process control issues related to instrumentation and control systems.
Design and test of automated process equipment. Support new product and technology introductions by performing engineering assessments, implementing automation system configuration changes, and supporting engineering runs.
Support capital projects by applying advanced automation engineering principles in the design, specification, configuration, startup, and commissioning of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred. Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations.
Development of detailed specification, engineering documents, SOPs, and operating standards.

*Education: B.S or M.S. in Chemical Engineering, Biotech, Electrical Engineering, Computer Science, or related technical field that reviews automation or engineering control.
Working knowledge on networking and virtual server architecture
Strong control system automation background in design, installation, programming, and validation of automated processes.
Working knowledge of manufacturing IT networks and network communication (TCP/IP, Profibus, Ethernet, wireless, fieldbus, WAGO IO, etc.)
Ability to read and follow electrical and P&ID drawings.
Direct experience with bioprocess unit operations such as bioreactors, chromatography, filtration, et cetera.
Strong communication/presentation skills especially with engineering documentation.
*Must have knowledge level to independently coordinate with vendors to renew service
*Must be independent, self-motivated, organized, and able to multi-task.
*Engineering experience- from college grad to 2 years
*Must be willing to be on call

Red Flags:

Inability to discuss skills listed on their resume during the job interview
Multiple short contracts

Interview process:

Virtual interview with manager
Vqirtual interview with team members next

Senior Bioprocess Equipment Reliability Engineer – Pilot Plant (JP15631) - Thousand Oaks, CA

Mon, 27 Jul 2026 16:07:28 GMT

Job Title: Senior Bioprocess Equipment Reliability Engineer – Pilot Plant - (JP15631)
Location: Thousand Oaks, CA. 91307
Employment Type: Contract
Business Unit: Pilot Plant Engineering
Duration: 12 months with likely extensions and/or conversion to permanent
Posting Date: 07/27/2026
Pay Rate: $42 - $48/hour W2 with benefits
Note: 100% Onsite pref. local candidate.
8-5PM with potential overtime and on-call rotation.

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

Job Description:
This role serves as an Equipment Sr. Engineer supporting manufacturing in the Thousand Oaks Pilot Plant (non-GMP environment). The engineer is responsible for the reliability, performance, and lifecycle management of assigned process equipment (e.g., bioreactors, chromatography skid, single-use and stainless systems).
The position provides day-to-day onsite technical support to operations, with emphasis on troubleshooting, maintenance coordination, and data-driven decision-making. The engineer partners closely with Operations and support functions to guide technical decisions during equipment issues, process changes, and system improvements, without directly operating equipment.

This role also supports preventive maintenance strategy, asset management (e.g., Maximo), and new equipment introduction, ensuring systems are effectively integrated and maintained for
evolving process needs. Additionally, the engineer is expected to identify opportunities to leverage digital tools and Al to enhance troubleshooting, reliability, and workflow efficiency.
This role requires independence, technical depth, a strong reliability mindset, and effective cross-functional collaboration in a fast-paced development environment.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Equipment Troubleshooting & RCA: Can independently diagnose issues and clearly explain
root cause and resolution
System Ownership & Reliability: Experience owning equipment, managing PMs, and improving
reliability using data
Cross-Functional Communication: Works effectively with Ops, Maintenance, and support
teams; communicates clearly during issues

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 yearsof experience (Can accept 2 years of experience as long as they have a relevant Pharma-manufacturing engineer experience) OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Day to day responsibilities:

Provide engineering support for bioprocess equipment including systems such as bioreactors, chromatography skids, TFF/UFDF, cleaning, single-use and stainless systems to ensure reliable operation
Troubleshoot equipment issues, lead root cause analysis, and implement solutions to improve performance and reliability
Identify and mitigate equipment risks (e.g., failure modes, obsolescence) and drive proactive improvements
Apply engineering fundamentals (thermodynamics, fluid systems, piping, electrical, process controls) to evaluate and resolve issues
Utilize Maximo (or similar CMMS) to manage work orders, track asset history, and support maintenance planning
Analyze system and process data using engineering and statistical methods (e.g., trend analysis, SPC) to support decision-making and continuous improvement
Support equipment design, commissioning, startup, and system integration for new or modified systems
Translate process and operational needs into engineering solutions and documentation
Collaborate cross-functionally with Operations, Maintenance, Instrumentation, Facilities, and Process Development
Manage multiple priorities independently in a fast-paced environment
Identify and implement opportunities to leverage digital tools and Al to improve efficiency and troubleshooting
Apply appropriate GMP awareness where relevant while operating effectively in a non-GMP pilot plant environment
Lead or support small scope engineering projects, including planning, execution, and cross-functional coordination, to address operational needs and drive continuous improvement.
Maintain a consistent on-site presence to support daily operations, with flexibility to provide weekend shift coverage and after-hours support as needed.

Red Flags:
• Superficial troubleshooting (can't explain how they resolved the issue)
• No ownership experience (only supported work, no accountability)
• Poor cross-functional mindset (blames others, lacks coordination examples
• No Computerized maintenance system / Maximo experience
• Inability/non-committal to relocate and work onsite
• Not data-driven (no use of trends/metrics)
• Cannot speak to resume in detail
• No work experience

Interview process:
1. Phone Screening with Hiring Manager
2. Video Panel Interview with Engineer team
3. Video Panel Interview with Manager 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.

Scientist / Engineer – Drug Product Technical Transfer & Fill-Finish (JP15621) - Thousand Oaks, CA

Thu, 23 Jul 2026 11:24:26 GMT

Job Title: Scientist / Engineer – Drug Product Technical Transfer & Fill-Finish (JP15621)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 07/23/26
Pay Rate: $40 - $46/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring a Scientist / Engineer – Drug Product Technical Transfer & Fill-Finish for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
We are seeking an Associate Scientist to support technical transfer and lifecycle-management activities for commercial drug product fill-finish processes. The individual will support transfers between development and manufacturing sites and will work closely with Process Development, Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering, and other cross-functional partners.

The role will emphasize preparation and review of technical transfer documentation, study protocols, reports, process assessments, product impact assessments, and regulatory-support documents. The candidate will also support process characterization and laboratory-based activities as needed.

The successful candidate will have a strong understanding of end-to-end drug product manufacturing, including formulation, mixing, hold operations, sterile filtration, filling, lyophilization, and product-contact systems. Time will be divided between supporting laboratory and process-development activities and developing clear, scientifically rigorous technical documentation.

The ideal candidate will have at least 3 years of drug product process development, manufacturing support, or technical transfer experience in the pharmaceutical or biotechnology industry. Candidates may come from a scientific or engineering background and may have held previous titles such as Associate Scientist, Scientist, or Engineer.

This role will have a strong focus on technical transfer documentation, data evaluation, and cross-functional project support. The candidate must also have sufficient hands-on laboratory and drug product process experience to understand the underlying science, critically evaluate study results, and develop technically sound documentation.

Previous client or pharmaceutical industry experience is preferred. Experience supporting intravenous bag preparation, compatibility, or administration-system studies is a plus.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Drug product fill-finish and technical transfer experience
Strong understanding of formulation, mixing, sterile filtration, filling, and transfer of parenteral drug product processes between development and commercial manufacturing sites.
Technical writing and data interpretation
Demonstrated ability to author, data-verify, and review technical protocols, reports, impact assessments, transfer documents, and regulatory-support documentation.
Hands-on laboratory and analytical experience
Experience executing drug product experiments and analytical testing, including formulation, filtration, pipetting, pH, protein concentration, viscosity, and osmolality

Day to Day Responsibilities:

Author, data-verify, and review technical transfer documents, study protocols, technical reports, product impact assessments, data summaries, and regulatory-support documentation.
Compile, analyze, and interpret development and manufacturing data to support technical transfer, process characterization, validation, and regulatory filings.
Execute laboratory analytical testing, including viscosity, protein concentration, pH, osmolality, and other relevant product-quality measurements.
Execute laboratory experiments involving pipetting, formulation, mixing, filtration, sampling, and product-contact evaluations.
Provide technical support for drug product fill-finish processes, including formulation, mixing, filtration, and filling of vials, syringes, devices, and other parenteral presentations.
Assist with the development and characterization of drug product processes and transfer of technologies between development and commercial sterile fill-finish sites.
Support commercial drug product activities involving sterile processing, process characterization, technical transfer, validation, and lifecycle management.
Evaluate site-to-site differences in equipment, materials, scale, process parameters, and manufacturing procedures.
Collaborate with Manufacturing, Quality, Regulatory, Analytical Sciences, Engineering, and other support functions to advance technical transfer and commercial manufacturing activities.
Participate in global cross-functional teams and work effectively within a highly matrixed environment.
Troubleshoot drug product processing technologies and equipment using data-driven analyses and visualizations to identify root causes and recommend solutions.
Support product-contact, IV bag, compatibility, or administration-system studies, as needed.
Assist with transfer readiness, site assessments, comparability evaluations, and validation support.

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:

Previous client or pharmaceutical industry experience is preferred. Experience supporting intravenous bag preparation, compatibility, or administration-system studies is a plus.

Red Flags:

Multiple short-term roles without a clear contract- or project-based explanation.
Limited direct drug product fill-finish or technical-transfer experience.
Strong documentation claims without demonstrated technical depth, data interpretation, or hands-on laboratory experience.

Interview process:
phone interview with hiring manager, supplemental interview with team. Can start interviewing now.
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 Automation Engineer – PLC Controls & Packaging Systems (Night Shift) - (JP15586) - New Albany, OH

Wed, 22 Jul 2026 15:33:44 GMT

Job Title: Associate Manufacturing Automation Engineer – PLC Controls & Packaging Systems (Night Shift) - (JP15586)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Manufacturing Systems Engineering
Duration: 10+ months (with likely extensions and/or conversion to permanent)
Posting Date: 07/22/26
Pay Rate: $26 - $31/hour W2
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 Manufacturing Automation Engineer – PLC Controls & Packaging Systems for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Associate Manufacturing Systems Engineer provides technical engineering support for manufacturing equipment and automation systems within the Inspection and Packaging area. This role focuses on optimizing equipment performance, improving system reliability, and supporting maintenance and troubleshooting activities in a GMP-regulated manufacturing environment. The ideal candidate has a strong automation background with hands-on PLC troubleshooting experience and enjoys working collaboratively with maintenance, engineering, and operations teams to resolve complex technical issues.

This position supports non-standard shifts and plays a key role in maintaining compliance with FDA regulations, industry standards, and company quality requirements while driving continuous improvement initiatives.

The successful Associate Manufacturing Systems Engineer is a hands-on technical problem solver who quickly diagnoses automation and equipment issues, partners effectively with maintenance and operations teams, and helps maximize equipment reliability while maintaining the highest standards of quality, safety, and regulatory compliance. They combine practical automation expertise with strong communication skills to support production and drive continuous improvement across the manufacturing operation.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Experience troubleshooting PLC-controlled manufacturing equipment, preferably using Allen-Bradley, Siemens, and B+R.
Working knowledge of electrical troubleshooting, sensors, motors, VFDs, and industrial control systems.
Excellent verbal and written communication skills.

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
Provide technical engineering support for manufacturing equipment, automation systems, and utility systems in the Inspection and Packaging area.
Support equipment optimization strategies, system upgrades, replacements, modifications, and continuous improvement initiatives.
Troubleshoot electrical and automation issues on production and packaging equipment, minimizing downtime and improving equipment reliability.
Read and interpret PLC ladder logic to diagnose equipment faults and collaborate with controls engineers on corrective actions.
Support and troubleshoot HMI interfaces, automation controls, sensors, drives, and related electrical components.
Partner closely with mechanical maintenance technicians to identify and resolve equipment performance issues.
Evaluate utility systems, process maintenance, instrumentation, calibration, electrical systems, and technical cleaning systems to ensure compliance with GMP, FDA, and applicable industry standards.
Assist in root cause investigations and implement corrective and preventive actions (CAPAs) to improve equipment performance.
Support equipment qualifications, commissioning activities, and validation efforts as required.
Develop and maintain technical documentation including SOPs, work instructions, engineering documentation, and maintenance procedures.
Participate in change control activities and ensure engineering changes are executed in accordance with quality and regulatory requirements.
Provide technical support during planned maintenance activities and production events on non-standard shifts.
Promote a culture of safety, compliance, and operational excellence.

Basic Qualifications:

Bachelor's degree in Engineering, Engineering Technology, Electrical Engineering, Mechanical Engineering, Mechatronics, or a related technical field OR equivalent combination of education and relevant automation experience.
2+ years of experience as an Automation Technician, Controls Technician, Electrical Technician, or similar automation-focused role.
Experience troubleshooting PLC-controlled manufacturing equipment.
Ability to read and interpret PLC ladder logic for troubleshooting purposes.
Familiarity with Human Machine Interfaces (HMIs) and industrial automation systems.
Experience supporting automated packaging, inspection, or manufacturing equipment.
Working knowledge of electrical troubleshooting, sensors, motors, VFDs, and industrial control systems.
Strong analytical, troubleshooting, and problem-solving skills.
Excellent verbal and written communication skills.
Ability to work effectively on non-standard shifts and respond to production support needs.

Preferred Qualifications:

Experience in pharmaceutical, biotechnology, medical device, food & beverage, or other highly automated manufacturing environments.
Experience working in a GMP and FDA-regulated environment.
Familiarity with Allen-Bradley/Rockwell PLCs, Siemens PLCs, or similar industrial control platforms.
Knowledge of SCADA systems, industrial networking, and process automation.
Experience supporting serialization, vision systems, robotics, or high-speed packaging equipment.
Understanding of calibration, instrumentation, and utility systems.
Experience participating in root cause analysis and continuous improvement initiatives.
Hands-on automation troubleshooting
PLC ladder logic interpretation
Electrical diagnostics
HMI operation and troubleshooting
Packaging equipment expertise
Mechanical and electrical collaboration
Root cause analysis
GMP and FDA compliance
Continuous improvement mindset
Strong communication and teamwork
Technical problem solving
Adaptability in a fast-paced manufacturing environment

Red Flags:

No demonstrated PLC experience.
Poor communication.

Interview process:
2 interviews, both via Microsoft Teams.
The first will be a one-on-one interview with me. 15-25 minutes.
The second will be a panel interview with two or three people. 30 - 45 minutes

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 Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15626) - Thousand Oaks, CA

Wed, 22 Jul 2026 14:06:14 GMT

Job Title: Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15626)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Electromechanical Platform
Duration: 1+ year with likely extensions and/or conversion to permanent
Posting Date: 07/23/2026
Pay Rate: $44 - $48/hour W2 with benefits
Notes: 3-5 days onsite depending on business needs - Standard hours - Local Candidates Only.

3 Key Consulting is hiring a Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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 and testing.

Our client is seeking a contract electromechanical combination product Device Engineer. The Device Engineer will participate in design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Lifecycle Management Experience with electromechanical platforms
Root Cause Analysis and Technical Problem Solving
Proven success in cross-functional engagement and being a team player
Nice to have: Early device development experience

Day to Day Responsibilities:

Provide ongoing lifecycle management (LCM) support for electromechanical combination products, including post-market activities, design improvements, and cross-functional issue resolution to ensure product reliability and compliance.
Lead complaint investigations by performing detailed failure analysis, identifying root causes, and developing data-driven action plans in collaboration with quality, manufacturing, and regulatory teams.
Drive and manage quality system processes including CAPAs, deviations, and change controls, ensuring timely closure, robust documentation, and alignment with regulatory and internal requirements.
Collaborate closely with external suppliers to support LCM activities, including issue resolution, component updates, root cause analysis, CAPAs and continuous improvement initiatives to maintain supply continuity and product performance.
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.
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.
Partner cross-functionally with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.

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:

- Master’s or Bachelor’s Degree in Engineering Discipline (Mechanical, Biomedical, Electrical) with 3-5 years (or 2 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, medical devices or delivery platforms preferred.
- Demonstrated expertise in lifecycle management, 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
- Must be capable of working on multiple projects in a deadline driven environment.
- The position is designed for candidates at a mid-career stage, with scope and responsibilities aligned to that level of experience.

Red Flags:

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
Candidates looking to be in a management role. Too much experience 10+ YOE.

Interview process:

1:1 with hiring manager

1:2 or 1:3 with prospective team members

Remote video Interviews

Senior CQV Validation Engineer – Combination Products & Packaging Manufacturing - (JP15567) - New Albany, OH

Thu, 16 Jul 2026 12:09:57 GMT

Job Title: Senior CQV Validation Engineer – Combination Products & Packaging Manufacturing - (JP15567)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process Development Group
Duration: 6+ months (with likely extensions and/or conversion to permanent)
Posting Date: 07/16/26
Pay Rate: $55 - $63/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring a Senior CQV Validation Engineer – Combination Products & Packaging Manufacturing for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Senior Validation Process Development Engineer serves as a technical leader responsible for supporting commercial GMP manufacturing operations while driving the development, characterization, optimization, and validation of automated and semi-automated combination product assembly and packaging processes. This role applies advanced engineering principles to ensure robust, compliant and efficient manufacturing processes that support both commercial production and new product introduction.

The engineer provides day-to-day technical support for commercial manufacturing through equipment and process troubleshooting, critical process parameter assessment and optimization, process performance monitoring, deviation investigations, root cause analysis, and implementation of continuous improvement initiatives to enhance product quality, process capability, and operational excellence.

Working cross-functionally with Manufacturing, Quality, Validation, Engineering and other technical organizations, the Senior Engineer leads complex engineering initiatives, resolves technical challenges, and identifies opportunities to improve equipment reliability, process performance, and manufacturing capability. This individual serves as a Subject Matter Expert (SME) for combination products, device assembly technologies, and GMP manufacturing processes, ensuring compliance with regulatory requirements while supporting the successful commercialization and lifecycle management of the business’s product portfolio.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Demonstrated experience leading Commissioning, Qualification, and Validation (CQV) activities within a GMP-regulated biotechnology or pharmaceutical manufacturing environment, with direct experience supporting packaging equipment, combination products, and/or device assembly processes.
Hands-on experience using electronic quality and document management systems, including KNEAT, Veeva, TrackWise, or equivalent platforms for managing validation documentation, change controls, deviations, CAPAs, and quality records.
Ability and willingness to be onsite and support manufacturing operations during off-shift hours, including weekday and weekend night shifts, as required to execute validation activities, and support commercial manufacturing schedules.

Day to Day Responsibilities:
The engineer provides technical support for commercial manufacturing through equipment and process troubleshooting, critical process parameter optimization, deviation investigations, and continuous improvement. The role is responsible for authoring and executing engineering studies, characterization, Commissioning, Qualification, and Validation (CQV) protocols, and technical summary reports to support compliant and reliable manufacturing operations.

Key documentation responsibilities include authoring, executing, and/or approving technical documentation, including:

Characterization test protocols and reports
Commissioning, Qualification, and Validation (CQV) test protocols and reports for manufacturing equipment, computerized systems, and processes
Engineering studies and technical assessments
Validation Master Plans, Validation Plans, and Summary Reports
Technical reports supporting equipment lifecycle management, process improvements, technology transfers, and new product introductions (NPI)

Candidate lacks demonstrated hands-on experience leading Commissioning, Qualification, and Validation (CQV) activities within a GMP biotechnology or pharmaceutical manufacturing environment, including authoring and executing characterization, validation, and engineering test protocols, as well as preparing technical reports to support equipment/system qualification and process validation.
Candidate is unable to work autonomously or demonstrate strong technical ownership of commercial manufacturing support, including equipment and process troubleshooting, critical process parameter optimization, deviation investigations, root cause analysis, and the ability to implement data-driven process improvements in a regulated manufacturing environment.
Candidate is unwilling or unable to work onsite to support commercial manufacturing during off-shift operations, including weekday and weekend night work, or lacks the flexibility required to execute validation activities and provide engineering support during critical manufacturing, qualification, and project schedules.

Interview process:
Microsoft Teams Virtual Interviews (1:1 or 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.

Automation Senior Engineer (Delta-V DSC), Biopharma – JP15562 - Thousand Oaks, CA

Thu, 16 Jul 2026 11:31:21 GMT

Job Title: Automation Senior Engineer (Delta-V DSC), Biopharma – JP15562
Location: Thousand Oaks, CA. 91320
Business Unit: GMP Facilities & Equipment Automation
Employment Type: Contract
Duration: 12 months with likely extensions and/or conversion to permanent
Rate: $40 - $50/hour W2 with Benefits
Posting Date: 07/16/2026
Notes: Onsite M-F 8-5. Will review candidates from all industries. Open to candidates that are willing to relocate

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

Job Description:
Our client 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.

Top Must Have Skill Sets:

Emerson Delta-V DCS Programming Experience, Rockwell Automation
SCADA and PLC Experience, Compliance with regulatory requirements such as 21 CFR Part 11

Basic Qualifications
Doctorate degree OR Masters degree and 2 years of relevant 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

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 CMDB systems.
Ensure compliance to 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.

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

Interview Process:
1 with Hiring Manager and 1 with Team. Immediate Availability to start
interviewing. Interviews will be 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, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15557) - Thousand Oaks, CA

Tue, 14 Jul 2026 10:49:48 GMT

Job Title: Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15557)
Location: Thousand Oaks, CA. 91320
Business Unit: Complaints Investigations
Employment Type: Contract
Duration: 12 months with likely extensions and/or conversion to permanent
Rate: $40 - $46/hour W2 with Benefits
Posting Date: 07/14/2026
Notes: Onsite 80%, must be available to go onsite when needed. Preferably Local candidates

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.

Job Description:
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 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.

JOB RESPONSIBILITIES:

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

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
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.
Demonstrated competency in root cause analysis methodology

Top Must Have Skill Sets:

Experience in lab environment
Able to collaborate and communicate with cross functional team
Experience in technical investigation and root cause analysis

Day to Day Responsibilities:

Perform device assessments of complaints return units in Lab 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
Perform root cause analysis investigations for mechanical and/or electromechanical products (as needed)

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

Red Flags:
Inability to commute to Thousand Oaks Facility
No technical background or experience
Lack of basic qualifications and must have skills

Interview Process:
Phone screening (15-30 min with hiring manager)
Video call / interview with cross-functional team (3-4 members, ~30-45 mins)

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.

Container Closure Integrity (CCI) Validation Engineer - (JP15515) - Thousand Oaks, CA

Tue, 07 Jul 2026 11:08:48 GMT

Job Title: Container Closure Integrity (CCI) Validation Engineer - (JP15515)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Physical Methods Development, Modelling and Emerging Methods
Duration: 18+ monthsr (with likely extensions and/or conversion to permanent)
Posting Date: 07/07/26
Pay Rate: $42 - $47/hour W2
Notes: Only qualified candidates need apply. Onsite USTO - 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 a Container Closure Integrity (CCI) Validation Engineer 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 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

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Solid modeling
Technical Writing
Working in a team
Nice to have: STEM related degree

Day to Day Responsibilities:

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

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.

CQV Validation Engineer, Biotech GMP Equipment – Remote (JP15497) - Thousand Oaks, CA

Tue, 16 Jun 2026 15:59:00 GMT

Job Title: CQV Validation Engineer, Biotech GMP Equipment – Remote (JP15497)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Engineering Systems
Duration: 12+ months with likely extensions and/or conversion to permanent
Posting Date: 06/16/2026
Pay Rate: $46 - $52/hour W2 with benefits
Notes: Fully Remote.

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

Job Description:
Primarily responsible for planning, coordinating, executing, and documenting periodic reviews of GMP equipment to ensure continued state of validation, compliance with regulatory requirements, and suitability for intended use. The role partners with Engineering, Manufacturing, Quality Assurance, Validation, and Maintenance teams to assess equipment performance, maintenance history, calibration status, deviations, change controls, and overall lifecycle management.

Key skills and requirements:
• Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV/validation maintenance role.
• Knowledge of cGMP commissioning/qualification/validation practices.
• Familiarity with biotech/pharmaceutical manufacturing equipment.
• Familiarity with Kneat Gx Platform or other digital C&Q systems.
• Experience working with cross-functional stakeholders.
• Knowledge of quality assurance principles including deviations and change control systems.
• Effective communication skills, both verbal and written.
• Able to think analytically with the ability to resolve issues.
• Able to manage own time efficiently.
Position could be extended to up to 3 years

Why is the Position Open?
Planned Project.

Top Must Have Skills:
Experience in commissioning/qualification/validation, experience in a GMP environment, knowledge of biotech/pharmaceutical manufacturing equipment

Day to Day Responsibilities:
• Execute periodic reviews of GMP equipment according to approved procedures and schedules. Assess
equipment records including work orders, deviations, and change control records.
• Evaluate equipment records to verify continued fitness for intended use.
• Generate and/or revise periodic review reports.
• Collaborate with Manufacturing, System Owners, Validation, and Quality teams as needed.
• Schedule and lead review meetings as needed to resolve issues.
• Ensure reviews are completed within established timelines and regulatory expectations.
• Maintain periodic review trackers and metrics.
• Identify opportunities to improve the equipment periodic review process.
• Other duties may be assigned to this role.

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:
Short tenures at previous jobs (<2 years)
No experience in commissioning/qualification/validation

Interview process:
1-2 Stages of interview | Video interview (Teams)

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 CQV Engineer – GMP Equipment, Utilities & Facilities Qualification - (JP15486) - Thousand Oaks, CA

Tue, 16 Jun 2026 15:50:55 GMT

Job Title: Senior CQV Engineer – GMP Equipment, Utilities & Facilities Qualification - (JP15486)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Engineering Systems
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 06/16/26
Pay Rate: $66 - $72/hour W2
Notes: Only qualified candidates need apply. Local, onsite at least 3 days weekly 8-5

3 Key Consulting is hiring a Senior CQV Engineer – GMP Equipment, Utilities & Facilities Qualification for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities. Responsibilities include generating/reviewing/executing C&Q protocols, plans, and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities.

Why is the Position Open?
Planned Project.

Top Must Have Skills:

Experience in commissioning/qualification/validation
Experience in a GMP environment

Day to Day Responsibilities:

Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
Work with project teams to develop the commissioning and qualification strategy and document in qualification plans.
Generate/evaluate qualification/validation protocols including IQ, OQ, FT, PQ protocols and final reports for new or modified GMP analytical and process equipment, utilities, and facilities.
Execute IQ, OQ, FT, PQ protocols, which may involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP analytical and process equipment, utilities, and facilities.
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.
Develop and/or execute FAT/SAT and other commissioning activities for new GMP systems in collaboration with both internal and external partners.
May include conducting validation maintenance activities including performing and scheduling periodic reviews.
Other duties may be assigned to this role.

Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV role.
Knowledge of cGMP commissioning/qualification/validation practices.
Familiarity with Kneat Gx Platform or other digital C&Q systems.
Experience working with cross-functional stakeholders.
Knowledge of quality assurance principles.
Experience working within project teams and multiple projects in parallel.
Effective communication skills, both verbal and written.
Able to think analytically with the ability to resolve issues.
Able to manage own time efficiently.

Red Flags:
Short tenures at previous jobs (?2 years), not local and not willing to relocate

Interview process:
1-2 Stages of interview | Video interview (Teams)

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.

Mechanical / Biomedical Engineer – Combination Products Test Methods & Validation (GMP, Gage R&R, Auto-Injectors) - (JP15464) - Thousand Oaks, CA

Tue, 16 Jun 2026 12:19:51 GMT

Job Title: Mechanical / Biomedical Engineer – Combination Products Test Methods & Validation (GMP, Gage R&R, Auto-Injectors) - (JP15464)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Physical Testing Systems Development
Duration: 18+ months (with likely extensions and/or conversion to permanent)
Posting Date: 06/16/26
Pay Rate: $42 - $46/hour W2
Notes: Only qualified candidates need apply. Candidates local or open to relocating to Thousand Oaks are welcomed. Hybrid.

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

Job Description:
The ideal candidate is a Mechanical or Biomedical Engineer with a Bachelor's degree and 1–3 years of industry experience, preferably within the pharmaceutical, medical device, or biomedical sectors. Candidates should possess hands-on experience with statistical analysis, Gauge R&R studies, and optical measurement systems, along with a working knowledge of CAD/SolidWorks for basic mechanical designs and test fixtures. Strong technical writing skills and familiarity with GMP documentation practices are essential. The successful candidate will be a motivated self-starter who enjoys solving technical challenges, learning new technologies, and working effectively both independently and within cross-functional teams.

This position supports the Combination Product Operations MS&T – Physical Sciences & Engineering (PSE) organization and involves assisting senior engineers with the initiation, design, execution, and delivery of engineering projects. Responsibilities include the development, validation, and lifecycle management of GMP physical test methods, integrated testing equipment, and test methods for auto-injectors and primary containers. The engineer will gather user requirements, develop technical documentation, perform engineering studies, assess automated testing systems, conduct field evaluations of existing equipment, and provide engineering recommendations to support project objectives and continuous improvement initiatives.

The ideal candidate has a passion for analytics, modeling, and technology, with the ability to organize information from multiple sources and transform it into well-structured deliverables. This role offers opportunities to apply engineering and data-driven approaches to improve decision-making, optimize testing processes, and support innovation within a highly regulated environment. The position is based at client's Thousand Oaks campus and follows a hybrid schedule, typically requiring two days onsite and three days remote per week, with flexibility based on project and business needs. Standard working hours are Monday through Friday, 8:00 AM to 5:00 PM Pacific Time.

Top Must Have 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,

Day to Day Responsibilities:

Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, 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 • Led the development of reference samples and test fixtures from concept to fabrication

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 force testers
Test method development, CAD design, Solid works, mechanical modeling
Manufacturing experience

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:

Not willing to commute to work (minimum twice a week)
Overqualified candidates (6+ years Pharmaceutical experience)
No Engineering experience
Job hopping (6 months or less at each place)

Interview process:
2 Stages of interview:

Phone screening with the hiring manager (1:1 interview with the hiring manager)
Panel interview if successfully passed the phone screening - Onsite

Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) - (JP15480) - New Albany, OH

Mon, 15 Jun 2026 14:46:31 GMT

Job Title: Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) - (JP15480)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Site Process Development
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 06/15/26
Pay Rate: $52 - $57/hour W2
Notes: Only qualified candidates need apply. Onsite AOH - Monday - Friday - Standard 8-5

3 Key Consulting is hiring a Principal Engineer – Drug Delivery Device Development (Electro-Mechanical Combination Products) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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. International travel may be required for this position.

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
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. They 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.

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:

BS in Engineering and previous experience in a medical device industry.
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
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 and limitation to travel. Approximately 1-2x per month
Unable to travel internationally

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.

Human Factors Engineer/Usability Engineering - Biopharma Medical Device Remote (JP15469) - Thousand Oaks, CA

Mon, 15 Jun 2026 11:03:21 GMT

Job Title: Human Factors Engineer/Usability Engineering - Biopharma Medical Device Remote (JP15469)
Location: Thousand Oaks, CA 91320
Business Unit: Human Factors / Usability Engineering
Employment Type: Contract
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 08/18/2025
Target start date: 6/15/2026
Pay Rate: $74-84/hr W2 with benefits
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.
What you will do:
In this vital role you are responsible for supporting HFE/UE planning, research, development and continuous improvement of client’s drug delivery devices using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. The Human Factors Engineer / Usability Engineer (HFE/UE) is expected to collaborate with internal and external partners and across functions including engineering, design, commercial, safety, risk, quality, regulatory and market surveillance teams. This person will support human factors research driving innovative, intuitive, and useful products. The HFE will support project study design, HFE/UE methodology, study moderation, data collection, and root cause analysis to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, and product validation in support of regulatory submissions.

Responsibilities:
The HFE/UE responsibilities include but are not limited to:

Work collaboratively with HFE/UE, engineering, design, commercial, and product teams to ensure successful translation of user requirements into products, to create user interface (UI) requirements, that meet the needs of users and enrich the overall user experience across client’s portfolio or programs.
Supporting usability activities such as study planning/coordination/management, protocol development, study moderation, data collection, material development, IRB submissions, participant recruitment, data analysis, and HFE/UE design history file documentation to support project needs.
Collaborate with the HFE/UE lead to ensure Human-system capabilities and limitations are properly reflected in the system requirements, and HFE/UE input is provided across functions to develop product design, packaging, labeling, and training requirements.
Support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors.
Analyze objective and subjective data from usability studies to inform design, inform risk minimization, and provide alternative design controls/solutions.
Support the HFE/UE lead in providing preparation for clinical studies and regulatory submissions in accordance with HFE/UE best practices, guidance and standards.
Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE/UE technical assessments, comparative analysis, HFE/UE reports, data verifications, and regulatory submissions.
Actively communicate with internal and external key stakeholders. Exercising critical thinking & educated HFE/UE judgement to determine appropriate next steps/actions.

Top Must Have Skills:
1. End to end human factors experience required from planning to validation and reporting
2. Must be able to demonstrate good technical writing skills
3. Good communicate skills and experience working with cross functional teams
4. Minimum experience needed with medical device but most importantly combination product experience

Preferred Qualifications: -

Master's degree in Human Factors, HFE/Usability Engineering, or other relevant HF/Engineering discipline and 2+ years of industry experience, working in multi-functional, fast-paced corporate environments.
Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, HF professional analysis, task analysis, hazard analysis, risk assessment, formative and summative studies.
Experience working directly with users to gather, synthesize and convert user research into concepts that differentiate products in the market, as well as to develop and evaluate new product features, user interfaces and ergonomic designs.
Experience using low and high-fidelity prototypes to identify and eliminate potential use errors early in the development process.
Experience working in development organizations, particularly virtual development environments contributing to systems design, verification, and validation milestones.
Ability to communicate effectively with mechanical, electrical, software, clinical, regulatory, safety, risk, and quality engineering disciplines.
The position requires good oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products.
Functional knowledge and experience in the practical application of relevant FDA human factors guidance, regulations and standards, including IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, and design controls.

Day to day responsibilities:
Support core development team(s) on all human factors activities, including attending remote meetings, communicating status to manager on all program requests, developing and recommending HFE strategies, and creating and approving HFE documents within Client's document management system.

Red Flags:
No direct experience leading HFE activities for combination product delivery devices. Only has academic research experience. A pattern of changing jobs every year. No medical device or pharmaceutical industry experience.

Interview process:
Candidate has a 25 minute phone interview with hiring manager. Candidate sends HFE writing example (redacted) to hiring manager. Candidate has a 50 minute panel interview. Candidate CV and panel interview results reviewed with senior leadership team. Decision to hire.

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.

Biologics Process Development Engineer – Purification & Technology Transfer - (JP15447) - Thousand Oaks, CA

Mon, 08 Jun 2026 14:39:58 GMT

Job Title: Biologics Process Development Engineer – Purification & Technology Transfer - (JP15447)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Development B23 Downstream 2
Duration: Initial 6+ months with likely extensions and/or conversion to permanent
Posting Date: 06/08/2026
Pay Rate: $42 - $46/hour W2
Notes: Only qualified candidates need apply. *Candidate will be required to be onsite 4-5 days a week and may work remotely 1-2 days a week. **Candidate will be required to work Standard business hours with occasional afterhours support **

3 Key Consulting is hiring a Biologics Process Development Engineer – Purification & Technology Transfer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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 mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation.

The Engineer will apply harvest and 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.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

2 YOE post graduation required
At- scale biologics purification knowledge and experience
Strong understanding of data analysis tools
Excellent communication and troubleshooting

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

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
Purification process knowledge
Knowledge of purification processes/equipment; scale-up factors from chromatography, UF/DF, 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

Red Flags:

Multiple short duration jobs on resume
No purification knowledge or experience

Interview process:
One round of phone screening with the hiring manager followed by panel interviews with the rest of the team (2 45 minute sessions with 3+ interviewers)

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 Automation Engineer – Packaging Systems (Rockwell PLC / GMP) - (JP15435) - New Albany, OH

Tue, 02 Jun 2026 14:43:49 GMT

Job Title: Manufacturing Automation Engineer – Packaging Systems (Rockwell PLC / GMP) - (JP15435)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: AOH Manufacturing Systems Engineering
Duration: 6+ months (with likely extensions and/or conversion to permanent)
Posting Date: 06/2/26
Pay Rate: $32 - $35/hour W2
Notes: Only qualified candidates need apply. Fully Onsite - Standard Hours

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

Position Overview:
This Engineer role reports to the Engineering & Maintenance organization and supports commercial GMP Final Drug Product (FDP) manufacturing operations at the client’s advanced assembly and packaging facility in New Albany, Ohio. The position applies advanced engineering and automation principles to packaging systems, manufacturing equipment, process optimization, troubleshooting, and continuous improvement initiatives. Approximately 15% travel may be required.

Why is the Position Open?
Planned Project

Top Must Have Skills:

PLC proficiency, specifically Rockwell / Allen-Bradley
Experience troubleshooting and repairing manufacturing/process equipment
Strong communication skills
Hands-on automation and equipment support experience preferred

Key Responsibilities:

Packaging Line & Manufacturing Support

Support commercial production packaging lines in a GMP-regulated manufacturing environment
Provide technical operations support to improve line performance, reliability, and capacity
Partner with Engineering, Maintenance, Manufacturing, Quality, and cross-functional teams to implement technical improvements
Support complex manufacturing, process optimization, scale-up, and continuous improvement initiatives

Automation System Design & Integration

Design and develop automation systems and control strategies for packaging machinery and manufacturing processes
Implement and configure PLCs, HMIs, and related automation equipment
Integrate new automation technologies into existing packaging systems
Create and maintain system specifications, design documents, operational procedures, and technical documentation

Troubleshooting & Technical Support

Diagnose and resolve automation system, controls, and manufacturing equipment issues
Provide hands-on troubleshooting support for production and maintenance teams
Perform system upgrades and maintenance to improve performance and reliability

Compliance & Validation

Ensure automation systems comply with FDA regulations, GMP standards, and industry best practices
Support validation activities and collaborate with Quality and regulatory teams on compliance-related issues
Apply knowledge of validation protocols and regulated manufacturing documentation requirements

Project & Technical Leadership

Support automation-related projects involving planning, design, reconfiguration, maintenance, and system improvements
Coordinate technical activities across stakeholders and site teams
Prepare project reports, performance metrics, and technical documentation
Train and support personnel on automation systems and related technologies

Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
Experience supporting pharmaceutical or biotech manufacturing operations, particularly final drug product packaging
Strong background in manufacturing process controls, automation systems, field instrumentation, and lifecycle management
Experience with Rockwell/Allen-Bradley platforms; exposure to Siemens, Machine Vision, Serialization, or Robotics technologies
Knowledge of Data Integrity, GMPs, GAMP, and regulated manufacturing environments
Understanding of validation execution requirements and new equipment installation processes
Strong technical writing, communication, problem-solving, and project coordination skills
Knowledge of Operational Excellence and Lean manufacturing principles

Red Flags:

This is not primarily a Validation Engineer or Project Manager role
Candidates must have strong hands-on PLC troubleshooting and continuous improvement experience

Interview process:
Virtual interview with manager.
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, Drug Delivery Device / Lab Testing & Troubleshooting – Biotech (JP15413) - Thousand Oaks, CA

Thu, 21 May 2026 14:52:20 GMT

Job Title: Engineer, Drug Delivery Device / Lab Testing & Troubleshooting – Biotech (JP15413)
Location: Thousand Oaks, CA
Employment Type: Contract
Business Unit: PFS & Kit Platform
Duration: 1+ years with possible extensions and/or conversion to permanent
Posting Date: 5/21/2026
Pay Rate: $43 - $47/hour W2
Target Start Date: 6/8/2026
Notes: Fully onsite

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 support the design, development, and lifecycle management of commercialized drug delivery devices within a regulated design control environment. This role combines hands-on laboratory execution with technical operations support and sustaining engineering activities for combination products from development through global launch.

The engineer will support mechanical drug delivery devices, including prefilled syringes, through laboratory testing, design verification support, failure investigations, design change assessments, and maintenance of Design History File (DHF) documentation and traceability records. A key aspect of the role is understanding how testing activities support user needs, product requirements, risk controls, and verification strategies within the design control process.

This position requires a candidate who is comfortable working directly in the laboratory while applying structured engineering and documentation practices in a regulated environment. The engineer will collaborate cross-functionally with scientists, engineers, quality, manufacturing, and operations partners to support product improvements, technical investigations, inspection readiness activities, and execution of key project deliverables.

The successful candidate will demonstrate strong technical judgment, attention to detail, and the ability to connect day-to-day execution with broader product quality, compliance, and development objectives.

Ideal Candidate
The ideal candidate is a hands-on engineer with experience executing laboratory testing, troubleshooting technical issues, and working within regulated product development environments. They are detail-oriented, organized, and capable of producing high-quality technical documentation and reliable experimental results.

They understand how laboratory activities support broader design control objectives, including traceability, risk management, verification strategies, and product quality. This person is able to connect user needs, product requirements, and test outcomes within a structured development process.

The ideal candidate demonstrates strong ownership, sound engineering judgment, and effective collaboration skills. They are comfortable managing multiple priorities in a fast-paced environment and are proactive in using digital tools such as Smartsheet, electronic lab notebooks, data visualization tools, and AI-enabled productivity tools to improve coordination, workflow efficiency, documentation quality, and team communication.

Key Responsibilities

Support the design, development, and lifecycle management of commercialized drug delivery devices within a regulated design control environment.
Contribute to sustaining engineering activities for mechanical delivery devices, including prefilled syringes, with responsibility for DHF maintenance, traceability, lifecycle documentation, and product improvements.
Plan, coordinate, and execute laboratory testing for device characterization, verification, design transfer, fill-finish support, and technical investigations.
Develop, execute, and document test methods, protocols, technical assessments, and reports using sound engineering principles and GMP documentation practices.
Ensure testing activities are clearly linked to user needs, design inputs, product requirements, risk controls, specifications, and verification objectives.
Analyze and interpret experimental data using engineering judgment and statistical tools to support technical decisions, investigations, design changes, and specification assessments.
Support root cause analysis, failure investigations, deviations, nonconformances, risk assessments, and design or manufacturing change evaluations.
Partner with engineering, quality, manufacturing, operations, and scientific teams to support product enhancements, launch activities, inspection readiness, and cross-functional deliverables.
Contribute to continuous improvement efforts that strengthen lab efficiency, testing reliability, documentation quality, traceability, and project visibility.
Use tools such as Smartsheet, Excel, electronic lab notebooks, data analysis platforms, and AI-enabled productivity tools to improve project coordination, workflow management, communication, and operational efficiency

Basic Qualifications

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, or a related engineering or scientific discipline.
Experience working in a regulated laboratory, medical device, pharmaceutical, biotechnology, or combination product environment.
Ability to independently plan, execute, document, and evaluate technical work using sound engineering or scientific principles.
Experience supporting laboratory testing, technical assessments, investigations, or product development activities.
Experience authoring or reviewing technical documentation in a regulated environment, such as protocols, reports, assessments, or investigation summaries.
Strong organizational skills with the ability to manage multiple priorities, maintain accurate records, and follow through on commitments.
Effective written and verbal communication skills with the ability to collaborate across technical and cross-functional teams.

Preferred Qualifications:

Bachelor’s degree or higher in a relevant engineering or scientific field
Experience with medical device, combination product, or regulated product development, particularly within a design control environment.
Familiarity with design controls and traceability across user needs, design inputs, product requirements, risk controls, specifications, and verification/validation activities.
Understanding of how intended use, user needs, and risk management inform testing strategies, requirements, and design decisions.
Experience supporting Design History File documentation, traceability matrices, design verification, design changes, or lifecycle management activities.
Hands-on laboratory experience with device characterization, test method development, fixture design, GR&R, or mechanical testing.
Experience with Instron force testers, BlueHill Universal, electronic lab notebooks, and statistical analysis tools such as Minitab or JMP.
Experience supporting investigations, deviations, nonconformances, root cause analysis, risk assessments, or change control records.
Experience using digital tools such as Smartsheet, Excel, data visualization tools, electronic lab notebooks, or AI-enabled productivity tools to improve project tracking, workflow efficiency, documentation quality, and team communication.
Strong technical writing, presentation, and stakeholder communication skills.
Ability to work independently and collaboratively across dynamic, cross-functional teams while supporting complex workstreams under demanding timelines.
Understanding of applicable regulations and standards, including:
o 21 CFR 820 – Quality System Regulation
o ISO 13485 – Quality Management Systems for Medical Devices
o ISO 14971 – Risk Management for Medical Devices
o EU Medical Device Regulation 2017/745

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

Top Must Have Skills:

Hands-on device testing and lab execution
Experience working in a regulated design control environment
Strong technical documentation, data analysis, and digital tool skills

Day to Day Responsibilities:

Execute hands-on laboratory testing and device evaluations.
Analyze and document technical data, results, and observations.
Troubleshoot issues and support investigations, root cause analysis, and design changes.
Maintain documentation and traceability within a regulated design control environment.
Collaborate with cross-functional teams to support product improvements and project execution.
Use digital tools to manage data, documentation, workflows, and communication.

Red Flags:
-Little to no hands-on experience
-Weak design control or documentation discipline
-Lack of organization, digital skills, or process-improvement mindset

Interview process:
1:1 Virtual (via Microsoft Teams) Interview with Hiring manager, with potential to proceed to virtual group 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.

Drug Substance/Product Process Engineer, Tech Transfer - Biopharma (JP15405) - Thousand Oaks, CA

Thu, 21 May 2026 14:37:27 GMT

Job Title: Drug Substance/Product Process Engineer, Tech Transfer - Biopharma (JP15405)
Location: Thousand Oaks, CA (Hybrid)
Employment Type: Contract
Business Unit: Process Engineering
Duration: 1+ years with possible extensions and/or conversion to permanent
Posting Date: 5/21/2026
Pay Rate: $43 - $47/hour W2
Notes: Hybrid | 2 Days onsite , 3 days remote per week

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical 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 internal manufacturing sites. The candidate will be 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 study design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups. The candidate will also be responsible for developing and maintaining trackers for project status and other key outputs for the team.

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 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 transfer documents, and change control assessments.
Support development of technology transfer tools (clinical and commercial) and automation of routine activities.
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
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, and AI

Preferred Qualifications:

B.S. in engineering or biotechnology discipline with 1‒3 years’ experience or M.S. in engineering or biotechnology discipline with 0‒2 years’ experience
Familiarity with cGMP and experience in drug products / 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 elevate 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:

Strong cross functional team player with good communication skills (oral and written).
Good computer and organizational skills with strong attention to detail.
Strong technical/engineering background with critical thinking, problem solving and independent research skills. Team player and self starter.

Day to Day Responsibilities:

Author, review, and data verify documents related to drug product tech transfers
Collaborate with team members to develop and maintain trackers for key performance indicators
Participate in study design and execution of experiments

Red Flags:

High frequency of job changes
Overqualified for the role

Interview process:
Phone interviews. Available to start with 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, Biologics Purification, Upstream/Downstream/Tech Transfer - Remote (JP15407) - Cambridge, MA

Thu, 21 May 2026 12:09:09 GMT

Job Title: Engineer, Biologics Purification, Upstream/Downstream/Tech Transfer - Remote (JP15407)
Location: Cambridge MA, Remote
Employment Type: Contract
Business Unit: Drug Substance Technology Engineering Group
Duration: 1+ years with possible extensions and/or conversion to permanent
Posting Date: 5/21/2026
Pay Rate: $34 - $37/hour W2
Notes: Remote (Any TZ - Local to Cambridge, MA is highly preferred.

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

Job Description:
Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client Cambridge site. Providing strong process engineering/ technology transfer support of human therapeutic drug substance 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. Knowledge of processes/equipment; scale-up factors, process deviations, quality attributes. GMP experience is a plus.

The Engineer will apply upstream and 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 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. Experience is technical report writing an expectation.
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.
Experience related to Process characterization for manufacturing of biologics highly preferred. This includes technical support for authoring and review of process characterization reports.

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

BASIC QUALIFICATIONS:
Master’s degree and 2 years of Engineering or Operations experience
Bachelor’s degree and 4 years of Engineering or Operations experience
Associate’s degree and 7 years of Engineering or Operations experience
High school diploma / GED and 8 years of Engineering or Operations experience

PREFERRED QUALIFICATIONS:

Master’s Degree in Chemical or Biochemical Engineering
2+ years of Process Engineering experience preferably related to downstream/ purification of commercial cGMP manufacturing facilities
Background in biologics technology transfer into commercial facilities, new product introductions (NPIs)
Biologics purification process knowledge: Knowledge of upstream ( cell culture/bioreactor operations) or purification processes (chromatography, viral filtration/inactivation, ultrafiltration/diafiltration, and final fill. )/ 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. Experience in PC documentation, report reviews and technical writing preferred.

Top Must Have Skills:

Cell culture experience, Purification /downstream experience, process characterization experience
Nice to have:
Monoclonal antibodies or mAbs
manufacturing or on floor support

Day to Day Responsibilities:
Assist senior staff in technical writing, process tech transfer, data monitoring

Red Flags:
No experience, not enough experience in biopharma or biotech, no experience in cell culture/upstream, purification/downstream or technical report writing

Interview process:
Teams interview. Screening 30 minute Microsoft team's interview with me. Second round- Team's interview 30 minute each approximately with 3 other 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 Engineering, Specialist Business Systems Analyst – Biopharma (JP15384) - New Albany, Oh

Thu, 14 May 2026 11:29:48 GMT

Job Title: Senior Engineering, Specialist Business Systems Analyst – Biopharma (JP15384)
Location: New Albany, OH 43054
Business Unit: Digital Thread & Strategic Capabilities
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $40-45/hours W2 with benefits
Posting Date: 5/14/2026
Target Start Date: 7/6/2026
Note: Fully Onsite with potential hybrid (will be confirmed by the manager)
Working Hours: Dayshift, Standard 8 - 5

3 Key Consulting is hiring! We are recruiting Specialist Business Systems Analyst for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:.
The Specialist Business Systems Analyst will be a key member of the program team working towards the implementation of Product Lifecycle Management (PLM). As a part of this cross-functional team within the Combination Product Operations (CPO) organization, you would assist with the deployment of the 3DEXPERIENCE PLM platform from Dassault Systems, that will help digitize combination product design, development, and technology transfer to company’s manufacturing network. The CPO Digital team is one of a network of company digital teams focused on implementing state of the art digital capabilities transforming the business by improving efficiency and speed, while reducing the cost of developing, manufacturing, and distributing combination products to our stakeholders and patients.

The successful candidate will work in a Scaled Agile Framework (SAFe) within several product teams working towards delivering capabilities across requirements management, specification management, manufacturing process planning, etc., acting as a voice of customer, ensuring the user needs are adequately met within the PLM platform. Additionally, the candidate will provide user support and feedback for system updates, enhancements, and data migration, and support the business in onboarding and training users in digitalized workflows and new capabilities.

Top Must Have Skill Sets:
• Ability to create strong requirements & user story development
• Experience in analyzing business process and creating new processes
• Experience in Agile/Scrum

Day to Day Responsibilities:

Document business processes for CPO Design and development (including but not limited to Specification management, Computer-aided design, Bill of Materials, etc.) in collaboration with appropriate SMEs within various departments across CPO and help identify gaps/opportunities for digitalization.
Own, maintain, and update business process documentation as per changes to source functional Standard operating procedures (SOPs), updated digital workflows, etc.
Support definition of functional area requirements for PLM platform and help manage User stories within the product backlog.
Represent functional area use cases in PLM Product/ Community/ Governance meetings
Escalate issues/requests to relevant PLM Product owners as necessary.
Support development, onboarding, and delivery of appropriate training to relevant user groups within CPO
Provide oversight of testing strategy by reviewing test scripts to ensure user story requirements are met.
Collect and document enhancement requests for CPO Digital workflows within PLM
Assist with development, execution, and tester support of User Acceptance testing (UATs)
Build functional area support network (appropriate SMEs/Process owners, etc.) to ensure up-to-date business process and needs documentation and input to PLM product team.
Support digital thread enablement (digitalization of experimental and operational workflows) and FAIR data practices.
Retrieving/processing and visualization of data
Generate reports and communicate insights to both technical

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

Red Flags:
- If someone has not worked in Agile/Scrum
- Someone that hasn't been part of a team that has had a software release

Interview Process:
1 phone call, 2 video calls.

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.

Data Analytics & Digital Transformation Engineer – Combination Products (JP15359) - Cambridge, MA

Wed, 13 May 2026 14:38:55 GMT

Job Title: Data Analytics & Digital Transformation Engineer - Combination Products (JP15359)
Location: Cambridge MA. (hybrid)
Business Unit: Combination Product Data Stewardship
Employment Type: Contract
Duration: 12 months with likely extensions or conversion to perm
Rate: $40-45/hours W2 with benefits
Posting Date: 5/13/2026
Target Start Date: 6/1/2026
Note: Hybrid - 3-4 days onsite

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: 2-5 YOE

Job Description:.
We are seeking a motivated and versatile Engineer to support the Combination Product Operations Digital and Data Strategy team. This is one of a network of company digital teams focused on implementing state of the art digital capabilities transforming the business by improving efficiency and speed, while reducing the cost of developing, manufacturing, and distributing combination products to our stakeholders and patients. This role bridges data analytics and digital transformation, enabling both operational insights and the advancement of enterprise digital capabilities.
The ideal candidate will contribute to data processing, visualization, and reporting efforts while also supporting Digital Product initiatives, digital thread enablement, and FAIR data practices. This individual will work across multiple cross-functional teams and stakeholders to improve workflows, enhance data usability, and drive adoption of digital tools and processes.

Key Responsibilities:
Data Processing & Analytics

Retrieve, clean, and preprocess data from multiple sources (databases, APIs, flat files).
Perform exploratory data analysis to identify trends, gaps, and opportunities.
Develop dashboards and visualizations using tools such as Spotfire, Power BI, or custom apps.
Generate reports and communicate insights to both technical and non-technical stakeholders.
Support data integrity, quality, and accessibility across workflows.
Digital Transformation & Digital Products Support
Support digital platform initiatives, including feature development, testing, and deployment.
Assist in documenting data models, workflows, and system architectures.
Contribute to the enablement of a digital thread across product development processes
Advocate for and apply FAIR (Findable, Accessible, Interoperable, Reusable) data principles
Act as a data steward to ensure consistency and usability of data across systems
Support onboarding, training, and adoption of digital tools across business groups
Cross-Functional Collaboration
Partner with multiple stakeholder groups to understand business needs and translate them into data and digital solutions
Identify process improvement opportunities to increase efficiency and reduce errors
Support digitalization of experimental and operational workflows
Work in a highly collaborative environment across technical and business teams

Top Must Have Skill Sets:
1) Data Engineering & Analytics Foundations
2) Digital Systems and Data Modeling Awareness (Exposure to data models, Understanding of how data flows across systems, etc).
3) Cross-Functional Collaboration & Digital Transformation Enablement

Day to Day Responsibilities:
Documentation, Testing, Organization of Timelines and management of deliverables, cross-functional collaboration.

Basic Qualifications:
• Bachelor’s degree in Engineering, Computer Science, Data Science, or related field
• 2+ years of experience in data analysis, digital systems, or related technical roles
Required Skills
• Experience with data processing and analysis using Python, R, or similar tools
• Familiarity with SQL and data querying
• Experience with data visualization tools (e.g., Tableau, Spotfire)
• Strong problem-solving and analytical skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong communication skills and ability to work with diverse stakeholders
Preferred Qualifications
• Experience with PLM systems or other enterprise digital tools
• Understanding of data modeling and data architecture concepts
• Exposure to Agile methodologies or product team environments
• Experience supporting digital transformation or system adoption initiatives
• Familiarity with combination products, medical devices, or regulated environments
• Strong communication and cross-functional collaboration skills - ability to distill, craft and present key messages relative to diverse audience requirements

Red Flags:
No previous data experience, Weak communication skills, and lack of technical writing experience.

Interview Process:
Virtual - 1:1 with the manager and 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.

Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices) - (JP15376) - Thousand Oaks, CA

Tue, 12 May 2026 12:32:25 GMT

Job Title: Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices) - (JP15376)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Complaints Trending Group
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 05/12/26
Pay Rate: $42 - $47/hour W2
Notes: Only qualified candidates need apply. Hybrid – must be on site 2 – 3 days per week. Standard hours.

3 Key Consulting is hiring a Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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.

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.

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.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

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

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 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.

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

Red Flags:

Candidates may be screened out if their resumes include vague or inconsistent descriptions of responsibilities, or do not demonstrate hands-on investigation, root cause analysis, or laboratory experience.
Poorly organized resumes or those that do not reflect strong communication skills or alignment with role requirements (including onsite availability) may also deter interview consideration.

Interview process:
A total of three interviews are planned, all to be conducted via phone. Interviews can begin as soon as possible, based on candidate availability.

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.

Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices) - (JP15369) - Thousand Oaks, CA

Mon, 11 May 2026 12:20:42 GMT

Job Title: Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices) - (JP15369)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Complaints Trending Group
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 05/11/26
Pay Rate: $42 - $47/hour W2
Notes: Only qualified candidates need apply. Hybrid – must be on site 2 – 3 days per week. Standard hours.

3 Key Consulting is hiring a Medical Device Complaint Investigation & Failure Analysis Engineer (Class II/III Devices) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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.

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.

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.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

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

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 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.

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

Red Flags:

Candidates may be screened out if their resumes include vague or inconsistent descriptions of responsibilities, or do not demonstrate hands-on investigation, root cause analysis, or laboratory experience.
Poorly organized resumes or those that do not reflect strong communication skills or alignment with role requirements (including onsite availability) may also deter interview consideration.

Senior Automation Engineer – DeltaV DCS / Rockwell PLC & SCADA (GMP Biopharma Capital Projects) (JP15356) - Thousand Oaks, CA

Fri, 08 May 2026 12:32:09 GMT

Job Title: Senior Automation Engineer – DeltaV DCS / Rockwell PLC & SCADA (GMP Biopharma Capital Projects) (JP15356)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Advanced Technology & Automation
Duration: 3 years (with potential for conversion to permanent)
Posting Date: 05/08/26
Pay Rate: $80 - $88/hour W2
Notes: Only qualified candidates need apply. Standard 8 - 5 Working Hours

3 Key Consulting is hiring an Senior Automation Engineer DeltaV DCS / Rockwell PLC & SCADA 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.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Must have direct programming experience in Rockwell and/or Emerson and/or HMI and/or Allen Bradley
Life Sciences GMP experience
Experience with supporting automation capital projects (qualification, testing)

Day to Day 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 cleint CMDB systems.
Ensure compliance to client’s 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.

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

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:

o Emerson Delta-V DCS system.
o Rockwell Automation SCADA and PLC Platform.
o ABB Robot and Mitsubishi roller bottle machine
o Emerson Delta-V DCS system.
o Electronic Batch Reporting Systems Design and implementation experience.
o Process Control Network design including network segregation.
o Process Control Systems: Virtual Infrastructure design and implementation.
o System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
o Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.

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, Drug Device Combination Product – Prefilled Syringes (JP15357) - Thousand Oaks, CA

Thu, 07 May 2026 16:30:20 GMT

Job Title: Engineer, Drug Device Combination Product – Prefilled Syringes (JP15357)
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: $40-46/hours W2 with benefits
Posting Date: 5/7/2026
Target Start Date: 6/1/2026

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)
Tolerance Stack-Ups (2D, 3D, RSS)
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:

Technical Writing and Succinct Communication of Technical Topics
In-Lab Testing
Tolerance Stack-Ups

Day to Day Responsibilities:
Documentation, Testing, Organization of Timelines and management of deliverables, cross-functional collaboration.

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:
Overly Timid, Non-Succinct Communication, Lack of Technical Basis

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:
Virtual - 1:1 with the manager and 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, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15323) - Thousand Oaks, CA

Mon, 04 May 2026 13:23:48 GMT

Job Title: Engineer, Complaints Technical Investigator, Drug Delivery Medical Devices (JP15323)
Location: Thousand Oaks, CA. 91320
Business Unit: Complaints Investigations
Employment Type: Contract
Duration: 12 months with likely extensions and/or conversion to permanent
Rate: $40 - $46/hour W2 with Benefits
Posting Date: 05/04/2026
Notes: Onsite 80%, must be available to go onsite when needed. Preferably Local candidates

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.

Job Description:
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 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.

JOB RESPONSIBILITIES:

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

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 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
• 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.
• Demonstrated competency in root cause analysis methodology

Top Must Have Skill Sets:

Experience in lab environment
Able to collaborate and communicate with cross functional team
Experience in technical investigation and root cause analysis

Day to Day Responsibilities:

Perform device assessments of complaints return units in Lab 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
Perform root cause analysis investigations for mechanical and/or electromechanical products (as needed)

Packaging Engineer – Drug Product Packaging & Verification Testing (JP15310) - New Albany, Ohio

Thu, 30 Apr 2026 16:40:14 GMT

Job Title: Packaging Engineer – Drug Product Packaging & Verification Testing (JP15310)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Development Breda
Duration: 1+ year with likely extensions and/or conversion to permanent
Posting Date: 04/30/2026
Pay Rate: $32 - $36/hour W2

Notes:
New drug product packaging
Packaging engineers / packaging verification testing
Open to other industries (food/ consumer product/cosmetics/home fragrance)
Multiple shifts might be required (1st, 2nd, 3rd) - Shift work possible, predominately M-F 8am-5pm, must be amenable to different shift when needed.

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

Position Overview:
This position reports into the Packaging Engineering group under Combination Product Operations (CPO) in Ohio (AOH). The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position utilizes physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes. A knowledge of common materials utilized in pharmaceutical packaging is key to this role. This role will support company’s manufacturing network by applying broad knowledge of pharmaceutical packaging operations, equipment, devices, and materials to develop the industry’s best combination product assembly and packaging processes. Understanding of packaging manufacturing equipment and processes and how materials interact with these is essential to the position. The job will require both planning and technical support of complex projects supporting a new site start-up. This role will be responsible for planning and overseeing projects to ensure on-time completion, establish priorities, report project status updates, and manage project dashboards for the Secondary Packaging Engineering team. This role will 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 role requires management, problem solving, communication (written and verbal), and organizational skills, and the ability to work in teams and adapt to rapidly changing environment. Project Management experience supporting implementation of commercial packaging configurations is preferred. Candidate must possess extensive knowledge and expertise in the use of project management methodologies and tools.

This position is responsible and accountable for the following:
• Project Management of entry level engineers and contingent workers
• Evaluation, recommendation and selection of new secondary packaging materials for pharmaceutical products
• Assessing complex problems relating to materials, recommending and implementing solutions
• Write test protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials
• Write Technical Specifications
• Representing Final Product Technologies as required
• Technology transfer from clinical to commercial or from site to site for packaging components and equipment processes
• Establish priorities to ensure all projects are managed within expected due dates
• Lead and present new packaging ideas, concepts and design ideas to the Product Development team
• Ensures cGMP and regulatory compliance are met
• Ensures that change control procedures are followed working with QA and Regulatory to implement changes
• Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc.) as needed
• Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities

Preferred Qualifications:
• Master’s degree in Packaging Engineering, Materials Science, Pharmacology, 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:

• Leading technical teams
• Independent thinker with demonstrated skills working in teams or leading technical project teams
• Strong Interpersonal and communication skills
• Project management
• Ability to manage competing priorities

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

Top Must Have Skills:

Excellent technical communication
Ability to manage multiple priorities
Excel in high pressure fast paced environment and professional

Red Flags:
Lack of strong communication skills
Lack of ability to learn new systems (SAP, PLM, Smartsheet, etc.)
Lack of flexibility

Interview process:
Video conference 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 – Primary Container & Device Testing / Analytical Lab Support (Vials, Syringes, Packaging Systems) – JP15291 - Thousand Oaks, CA

Thu, 30 Apr 2026 14:28:10 GMT

Job Title: Associate Engineer – Primary Container & Device Testing / Analytical Lab Support (Vials, Syringes, Packaging Systems) – JP15291
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: DP&DD Pre-Comm. Packaging Development
Duration: 18+ months (with likely extensions and/or conversion to permanent)
Posting Date: 04/30/26
Pay Rate: $30 - $34/hour W2
Notes: Only qualified candidates need apply. Role is expected to be onsite 3 times a week. Please send in local candidates. Candidates who either live within a 50 mile drive or would be willing to relocate. Contract is 18 months.

3 Key Consulting is hiring an Associate Engineer - Primary Container & Device Testing / Analytical Lab Support (Vials, Syringes, Packaging Systems) for a consulting engagement with our direct client, a leading global biopharmaceutical 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.

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

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

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
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

Red Flags:

Candidate has inflexible schedule
Candidate cannot work possible overtime
Candidate cannot work onsite at Thousand Oaks, CA
Bachelor’s degree not in Science or Engineering

Interview process:

One-on-one phone screening, followed by an in-person 1:6-10 person group interview (Virtual interviews for non-local candidates)

Interviews can start immediately

Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15315) - Thousand Oaks, CA

Thu, 30 Apr 2026 13:47:32 GMT

Job Title: Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15315)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Electromechanical Platform
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 04/30/26
Pay Rate: $44 - $48.50/hour W2
Notes: Only qualified candidates need apply. On site in Thousand Oaks, CA. 3-5 days onsite depending on business needs. Standard hours

3 Key Consulting is hiring an Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
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 and testing.

Our client is seeking a contract electromechanical combination product Device Engineer. The Device Engineer will participate in design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Lifecycle Management Experience with electromechanical platforms
Root Cause Analysis and Technical Problem Solving
Proven success in cross-functional engagement and being a team player
Nice to have: Early device development experience

Day to Day Responsibilities:

Provide ongoing lifecycle management (LCM) support for electromechanical combination products, including post-market activities, design improvements, and cross-functional issue resolution to ensure product reliability and compliance.
Lead complaint investigations by performing detailed failure analysis, identifying root causes, and developing data-driven action plans in collaboration with quality, manufacturing, and regulatory teams.
Drive and manage quality system processes including CAPAs, deviations, and change controls, ensuring timely closure, robust documentation, and alignment with regulatory and internal requirements.
Collaborate closely with external suppliers to support LCM activities, including issue resolution, component updates, root cause analysis, CAPAs and continuous improvement initiatives to maintain supply continuity and product performance.
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.
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.
Partner cross-functionally with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.

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:

- Master’s or Bachelor’s Degree in Engineering Discipline (Mechanical, Biomedical, Electrical) with 3-5 years (or 2 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, medical devices or delivery platforms preferred.
- Demonstrated expertise in lifecycle management, 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
- Must be capable of working on multiple projects in a deadline driven environment.
- The position is designed for candidates at a mid-career stage, with scope and responsibilities aligned to that level of experience.

Red Flags:

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
Candidates looking to be in a management role. Too much experience 10+ YOE.

Interview process:

1:1 with hiring manager

1:2 or 1:3 with prospective team members

Remote video Interviews

Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (Biologics / Combination Products / GMP) (JP15071N) - Thousand Oaks, CA

Wed, 29 Apr 2026 13:07:44 GMT

Job Title: Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (Biologics / Combination Products / GMP) (JP15071N)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Function: Process Development / Engineering / Operations
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 04/29/26
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply. Standard hours. Not looking for degree in Packaging Engineering.

3 Key Consulting is hiring a Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (Biologics / Combination Products / GMP) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
** Not looking for candidates with a packaging engineering degree**

This role supports our client’s Manufacturing Science & Technology organization and is responsible for the development, optimization, qualification, and lifecycle management of secondary and tertiary packaging systems for commercial and development-stage products. The engineer will contribute to packaging solutions supporting biologics, sterile injectables, and combination products such as prefilled syringes and autoinjectors.

The successful candidate will work cross-functionally with Operations, Quality, Supply Chain, Regulatory, Device Development, and external suppliers to drive packaging innovation, improve manufacturability, ensure regulatory compliance, and support product launches, technology transfers, and supply continuity.

Key responsibilities include designing and improving cartons, labels, inserts, and distribution packaging; maintaining component specifications; leading engineering studies; evaluating new materials and packaging technologies; supporting supplier qualification activities; and ensuring packaging systems meet performance, traceability, and global compliance requirements.

This position requires a motivated engineer with strong communication skills, sound technical judgment, attention to detail, and the ability to influence stakeholders in a fast-paced manufacturing environment. Candidates with a passion for continuous improvement, innovation, and practical engineering execution will be highly valued.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Ability to influence through clear and concise verbal communication
Passion for innovation and continuous improvement
Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related engineering degree

Day to Day Responsibilities:

Lead development and optimization of secondary & tertiary packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors).
Create novel designs and maintain component specifications for cartons, labels, and distribution packaging.

Packaging manufacturing process engineering studies

Ensure compliance with global regulatory expectations
Prepare and review packaging documentation for regulatory submissions.
Support technology transfer, scale-up, and readiness activities at Amgen manufacturing sites and contract manufacturing locations.
Partner with suppliers and Supply Chain to qualify components, assess supplier capability, manage change notifications and implement new material technologies.
Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and traceability requirements.

Basic Qualifications:

Bachelor’s degree in Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
2+ years of professional scientific engineering experience. •

Excellent communication skills and ability to collaborate and influence across functions.
Attention to detail with a mindset of getting things done correctly and robustly the first time.
Ability to work onsite at Amgen’s Thousand Oaks campus.

Preferred Qualifications:

Master’s degree in Engineering or related field.
Experience with structural design, FEA and utilization of artificial intelligence
Experience with GMP, GDP, GD&T principles

Red Flags:

Long-winded, unconvincing answers to questions
Low energy
No Packaging Engineer Degrees (We’re Trying Different Degrees)

Interview process:

Up to 3 interviews
1st round with manager
2&3rd will be panels with other team members

Associate Engineer – Thermal Packaging Systems / Cold Chain Logistics / GMP Documentation & Project Support - (JP15311) - Thousand Oaks, CA

Wed, 29 Apr 2026 12:34:12 GMT

Job Title: Associate Engineer – Thermal Packaging Systems / Cold Chain Logistics / GMP Documentation & Project Support - (JP15311)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 6+ months (with likely extensions and/or conversion to permanent)
Posting Date: 04/29/26
Pay Rate: $28 - $34/hour W2
Notes: Only qualified candidates need apply. Hybrid Set Up - 2 days onsite per week. Working Hours: Standard 8AM - 5PM

3Key Consulting is hiring an Associate Engineer – Thermal Packaging Systems / Cold Chain Logistics / GMP Documentation & Project Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Associate Engineer position is part of the Thermal Engineering Systems (TES) group at our client’s Thousand Oaks, CA. facility. This role is responsible for supporting TES project management and documentation activities. Under the guidance of senior staff, the individual will apply engineering principles and adhere to current SOPs to support the design, qualification, and implementation of thermal packaging systems. In addition, the role includes assisting with transportation laboratory testing, conducting experimental studies, and documenting results in compliance with SOPs.

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

Top Must Have Skills:

Knowledge of GMP-Bio/Pharma background
Project management and documentation
Proven written and oral communication skills

Day to Day Responsibilities:

Track TES project progress and update project dashboard
Author and revise controlled documents in document management system
Assist lab test execution and conduct characterization studies for TES projects
Participate in shipping solution qualification projects
Lead weekly team meetings to review project updates and facilitate team discussions
Maintain and update the SharePoint project management dashboard to track progress
Support shipping solution qualification projects and troubleshooting activities
Assist with laboratory test execution, perform thermal experiments, analyze data, and generate reports
Author and revise controlled documents (SOPs, PCS, RPTs, APPXs) within CDOCS and PLM systems
Collaborate with cross-functional teams on protocol reviews, test preparation, change control processes, and deviation/CAPA management
Utilize MS Office Suite (Excel, Word, Visio, PowerPoint, etc.) to develop documentation

Basic Qualifications:

Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Bachelor’s degree in engineering or a related science field (biotechnology, chemical, or mechanical engineering preferred)
Prior laboratory experience and knowledge of pharmaceutical GMP/GDP practices
Experience with project management and GDocP (Good Documentation Practices) preferred
Strong verbal and written communication skills
Demonstrated ability to execute engineering tasks in accordance with SOPs and established procedures

Red Flags:

Candidates who lack relevant skills
Candidates who do not meet the qualification requirements
Candidates who were separated from previous employment due to unethical behaviors

Interview process:
Phone interview followed by in person interview 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.

Senior Equipment Reliability Engineer – Pilot Plant Bioprocess Systems (JP15269) - Thousand Oaks, CA

Thu, 23 Apr 2026 12:03:57 GMT

Job Title: Senior Equipment Reliability Engineer – Pilot Plant Bioprocess Systems (Bioreactors / Chromatography / TFF / CMMS / Troubleshooting / Onsite Support) JP15269
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: B30 Pilot Plant Engineering
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 04/23/26
Pay Rate: $45 - $50/hour W2
Notes: Only qualified candidates need apply. 100% onsite and we prefer a local candidate.

3 Key Consulting is hiring a Senior Equipment Reliability Engineer – Pilot Plant Bioprocess Systems for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This role serves as an Equipment Sr. Engineer supporting manufacturing in the Thousand Oaks Pilot Plant (non-GMP environment). The engineer is responsible for the reliability, performance, and lifecycle management of assigned process equipment (e.g., bioreactors, chromatography skid, single-use and stainless systems).

The position provides day-to-day onsite technical support to operations, with emphasis on troubleshooting, maintenance coordination, and data-driven decision-making. The engineer partners closely with Operations and support functions to guide technical decisions during equipment issues, process changes, and system improvements, without directly operating equipment.

This role also supports preventive maintenance strategy, asset management (e.g., Maximo), and new equipment introduction, ensuring systems are effectively integrated and maintained for evolving process needs. Additionally, the engineer is expected to identify opportunities to leverage digital tools and AI to enhance troubleshooting, reliability, and workflow efficiency.

This role requires independence, technical depth, a strong reliability mindset, and effective cross-functional collaboration in a fast-paced development environment.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Equipment Troubleshooting & RCA: Can independently diagnose issues and clearly explain root cause and resolution
System Ownership & Reliability: Experience owning equipment, managing PMs, and improving reliability using data
Cross-Functional Communication: Works effectively with Ops, Maintenance, and support teams; communicates clearly during issues

Day to Day Responsibilities:

Provide engineering support for bioprocess equipment including systems such as bioreactors, chromatography skids, TFF/UFDF, cleaning, single-use and stainless systems to ensure reliable operation
Troubleshoot equipment issues, lead root cause analysis, and implement solutions to improve performance and reliability
Identify and mitigate equipment risks (e.g., failure modes, obsolescence) and drive proactive improvements
Apply engineering fundamentals (thermodynamics, fluid systems, piping, electrical, process controls) to evaluate and resolve issues
Utilize Maximo (or similar CMMS) to manage work orders, track asset history, and support maintenance planning
Analyze system and process data using engineering and statistical methods (e.g., trend analysis, SPC) to support decision-making and continuous improvement
Support equipment design, commissioning, startup, and system integration for new or modified systems
Translate process and operational needs into engineering solutions and documentation
Collaborate cross-functionally with Operations, Maintenance, Instrumentation, Facilities, and Process Development
Manage multiple priorities independently in a fast-paced environment
Identify and implement opportunities to leverage digital tools and AI to improve efficiency and troubleshooting
Apply appropriate GMP awareness where relevant while operating effectively in a non-GMP pilot plant environment
Lead or support small scope engineering projects, including planning, execution, and cross-functional coordination, to address operational needs and drive continuous improvement.
Maintain a consistent on-site presence to support daily operations, with flexibility to provide weekend shift coverage and after-hours support as needed.

Superficial troubleshooting (can’t explain what they did)
No ownership experience (only “supported” work, no accountability)
Poor cross-functional mindset (blames others, lacks coordination examples)
No CMMS/Maximo exposure
Inability/non-committal to relocate and work onsite
Not data-driven (no use of trends/metrics)
Cannot speak to resume in detail
No work experience

Interview process:
1. Phone Screening with Hiring Manager
2. Video Panel Interview with Engineer team
3. Video Panel Interview with Manager 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, Allen Bradley PLC Electrical/Automation - (JP15246) - New Albany, Ohio

Tue, 21 Apr 2026 12:51:43 GMT

Job Title: Associate Engineer, Allen Bradley PLC Electrical/Automation - (JP15246)
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: 04/21/2026
Pay Rate: $28 - $32/hour W2 with benefits
Notes: 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, Allen Bradley PLC Electrical/Automation/ 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.

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.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Allen-Bradley PLC proficiency.
Electrical/automation troubleshooting of complex equipment.
Excellent communication skills.

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

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, GMP Production Line Support & Automation - (JP15234) - New Albany, OH

Tue, 14 Apr 2026 13:44:46 GMT

Job Title: Engineer, GMP Production Line Support & Automation - (JP15234)
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: 04/14/26
Pay Rate: $34 - $37/hour W2
Notes: Only qualified candidates need apply. Fully onsite. Some overtime may be required

3 Key Consulting is hiring an Engineer (GMP Production Support) 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 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.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

1–2+ years of hands-on experience in a GMP-regulated environment
Work In teams, communication
Mechanical systems experience

Day to Day Responsibilities:

Monitor daily operations of production lines.
Assist with troubleshooting downtime related issues, manage line improvements, work through CAPAs and deviations.

Previous intern experience is a plus.
Experience with automation is a plus.
Experience with computer programming, systems, and/or robotics is a plus
Experience working in an FDA-regulated environment
Familiarity with maintenance management software (e.g., Maximo)
Experience with 3D modeling tools such as SolidWorks or similar
Strong technical writing skills

Employee Value Proposition:
Opportunity to gain experience working in an FDA and GMP regulated environment.

Red Flags:

Inability to meet core job requirements.
Poor communication skills.
Unable to work OT as needed.
Flexibility is required as workload increases.

Interview process:
One on one - Panel interview

We invite qualified candidates to send your resume to0. 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.

Downstream Bioprocess Engineer – Drug Substance Tech Transfer & Manufacturing Support (Biologics) ( P15229) - Holly Springs, NC

Tue, 14 Apr 2026 10:17:51 GMT

Job Title: Downstream Bioprocess Engineer – Drug Substance Tech Transfer & Manufacturing Support (Biologics) (JP15229)
Location: Holly Springs, NC. 27540
Employment Type: Contract
Business Unit: Drug Substance
Duration: 1+ year with likely extensions and/or conversion to permanent
Posting Date: 4/14/2026
Pay Rate: $34 - $38/hour W2
Notes: Working Schedule: Dayshift with potential overtime

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

Job Details:
In this vital role you will be a part of the Process Development Drug Substance Technology group at FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

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

Top Must Have Skills:

Manufacturing support
Downstream
Tech transfer

Day to Day Responsibilities:

Apply a fundamental understanding of Downstream bioprocessing to support biologics technology transfer, process validation, plant start-up, MFG troubleshooting and investigations
Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
Ensure safety and compliance of process development activities
Provide person-in-plant on floor process support as required
Provide support for regulatory filing, inspection, and other CMC 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:
Not a team player

Interview process:
Phone with hiring manager, followed by virtual interviews with tech transfer 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.

Senior Azure Data & Integration Engineer (ADF, SSIS, APIs, iPaaS) - (CF0011) - Thousand Oaks, CA

Mon, 13 Apr 2026 11:22:40 GMT

Job Title: Senior Azure Data & Integration Engineer (ADF, SSIS, APIs, iPaaS) - (CF0011)
Location: Calabasas, CA. 91302 (Hybrid)
Employment Type: Permanent
Business Unit: Corporate IT
Posting Date: 04/13/2026
Compensation Range: $140,00 - $156,000/year
Notes: Only qualified candidates need apply. Eligible for a hybrid work schedule split between home & office, with a minimum of 3 days in the office each week.

3 Key Consulting has been retained to identify a Senior Azure Data & Integration Engineer (ADF, SSIS, APIs, iPaaS) for a permanent opportunity with our direct client, a leading multi-brand hospitality company with enterprise-scale operations.

IMPORTANT: Candidates must be authorized to work in the United States. This position is not open to new visa sponsorship. Candidates who require employer sponsorship now or in the future will not be considered. H-1B transfer candidates may be considered.

Job Description:
The Senior Data Engineer will be an integral part of the Integrations team within our Information Technology department. They will have the responsibility to design, develop, support, and optimize data pipelines and architectures using modern iPaaS solutions and other cloud-based data processing and storage solutions. They will collaborate with various stakeholders to identify data needs and utilize best practices to integrate with disparate systems for data sharing.

You’ll excel in this position if you are:

Deadline Driven: you understand that deliverables are due by a specific date and time, and your time management and work ethic gets you there with ease.
A Team Player: you’re a collaborative team player who shows respect for the views and contributions of others while building team spirit across the department.
Highly Organized: in a dynamic work environment with many moving parts, you easily prioritize your responsibilities while maintaining deadlines.
Adaptable: you’re at ease in a fast-paced environment and you’re able to change direction rapidly when priorities, deadlines, or personalities shift.
Accountable/Responsible: you’re able and willing to take initiative and ownership for getting things done (within a supportive team environment).

Top Must Have Skills:

Azure Data Factory (ADF) + End-to-End Data Pipeline Development
Data Integration (APIs, Messaging, System Connectivity)
Advanced SQL (Performance Tuning + Data Modeling)
Ownership & Accountability (Execution in a Complex Environment)
Cross-Functional Communication (Translating Business ↔ Technical)

Day to Day Responsibilities:

Design, develop, and maintain scalable, fault-tolerant data pipelines using ETL/ELT frameworks to support ingestion, transformation, and integration of structured and unstructured data.
Implement integration solutions with external systems via REST APIs, SOAP services, and message queues (e.g., RabbitMQ and Kafka) to enable real-time and batch data exchange.
Partner cross-functionally with Business Analysts, BI teams, and stakeholders to translate business requirements into technical designs, data contracts, and production-ready solutions.
Optimize and troubleshoot data systems (Azure SQL Database, Azure Data Factory, SSIS) for performance tuning, query optimization, and cost efficiency.
Design and implement robust data models for analytical and transactional systems ensuring referential integrity and scalability.
Implement best practices for data management, including data governance, security (RBAC, password less auth), compliance, and auditing using Azure Purview or similar tools.
Maintain comprehensive documentation of data workflows, architecture diagrams, and integration patterns.
Mentor and support junior engineers through code reviews, design guidance, and troubleshooting, helping raise overall engineering quality and delivery consistency.
Lead proofs of concept (POCs) and evaluate tools such as Snowflake, Databricks, and Airflow, providing recommendations to improve architecture, scalability, and operational maturity.
Leverage CI/CD pipelines for Azure functions, data factory and SSIS using GitHub Actions to ensure automated deployments and version control.
Work with cloud-native storage and compute services (Azure Blob Storage, Data Lake Gen2, Functions, Logic Apps, SSIS,ADF) for scalable data processing and integration.
Develop automation scripts in Python and PowerShell for data processing, orchestration, and operational efficiency.

Basic Qualifications:

5+ years of hands-on experience with Azure Data Factory, Azure SQL offerings, and SSIS.
Bachelor’s degree in Computer Science, Information Systems, Data Analytics, or a related field
Proficiency in SQL, Python, stored procedures and other data transformation techniques.
Expertise in optimizing SQL queries using query optimization techniques and other performance tuning strategies.
Scripting experience utilizing Python/PowerShell.
Experience with system design and data architecture, including scalable integration patterns.
Exposure to modern data platforms such as Databricks, Synapse, BigQuery, or Snowflake.
Experience with iPaaS tools (e.g., SnapLogic, TIBCO, Adeptia) and external system integrations.
Strong problem-solving and data debugging skills.
Demonstrated ability to learn and adapt to new technologies and methodologies.
Excellent communication skills and teamwork abilities.

Preferred Qualifications:

Restaurant industry experience.
Familiarity with other cloud-based technologies and services on Azure e.g. Logic Apps, Functions.
Experience building frameworks and utilities that standardize implementation of data quality, logging, monitoring etc.
Azure certifications e.g. Azure Fundamentals, Azure Data Fundamentals, Azure Data Engineer.
Experience mentoring engineers, setting standards, and contributing to technical roadmaps.

Benefits:

Vacation and sick time
Medical, Dental & Vision
401K with company match
Tuition reimbursement
25%-35% discount when dining as a guest
Annual stipend for dining in our restaurant

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.

Packaging Engineer – Biotech Combination Products/Device Operations (JP15206) - Thousand Oaks, CA

Thu, 09 Apr 2026 12:28:27 GMT

Job Title: Packaging Engineer – Biotech Combination Products/Device Operations (JP15206)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Packaging Engineering & Labeling
Duration: 1+ year with likely extensions and/or conversion to permanent.
Posting Date: 04/09/2026
Pay Rate: $36 - $41/hour W2 with Benefits
Notes: Hybrid - 3-4 days onsite - Standard hours

3 Key Consulting is hiring a Packaging 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 Products Operations (CPO) 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. Day-to-day commercial support, and Lifecycle Management.

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 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 environments
Independent problem solver 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 Skills:
Organizational, project management, technical problem solving and communication (written and verbal) skills. Medical devices or pharma, biotech experience. Lab based experience.

Day to Day Responsibilities:
Execute the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. Day-to-day commercial support, and Lifecycle Management.

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

Red Flags:
Not able to go on-site.
Not able physically move for a majority of the shift. (Walking between different buildings to grab equipment and working with different lab teams)

Interview process:
1-2 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.

Device Development & Testing Engineer – Drug Delivery / Combination Products (Lab, Failure Analysis, Design Controls)- (JP15205 - Thousand Oaks, CALIFORNIA

Wed, 08 Apr 2026 20:00:13 GMT

Job Title: Device Development & Testing Engineer – Drug Delivery / Combination Products (Lab, Failure Analysis, Design Controls)- (JP15205)
Location: Thousand Oaks, CA. 91320 - Hybrid
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 04/08/2026
Pay Rate: $36 - $41/hour W2
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 a Device Development & Testing Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate willl:

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 our client’s portfolio of drug delivery devices.

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 our 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 Amgen’s delivery device platform as needed to meet evolving product and regulatory requirements.

Why is the Position Open?
Planned Project

Top Must Have Skills:

Problem solving (engineering skillset)
Organization (self-starter and project level management)
Communication (experience communicating at different levels and to different groups)
Nice to have: 1-2 years of experience

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).

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:
-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
Inability to be present on site/support ATO-site 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 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.

Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) - (JP15071) - Thousand Oaks, CALIFORNIA

Mon, 06 Apr 2026 16:44:54 GMT

Job Title: Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) - (JP15071)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 04/24/2026
Pay Rate: $36-$41/W2
Notes: Only qualified candidates need apply. Thousand Oaks, CA Fully Onsite - Standard Hours

3 Key Consulting is hiring a Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This role is responsible for leading the development, optimization, and validation of secondary and tertiary packaging systems supporting biologics, sterile injectables, and combination products. The engineer will support packaging innovation, material selection, manufacturing readiness, and packaging performance across commercial and development programs.

The position requires strong collaboration and communication skills with the ability to influence cross-functional teams including Quality, Operations, Supply Chain, Manufacturing, Regulatory, and external suppliers. The engineer will support packaging studies including transportation simulation, aging, shelf-life, environmental conditioning, packaging process studies, and supplier qualification activities.

This is a highly visible role requiring a motivated engineer who brings strong problem-solving ability, continuous improvement mindset, technical curiosity, and a passion for driving robust packaging solutions.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:
Ability to influence through clear and concise verbal communication
Passion for innovation and continuous improvement
Demonstrated examples of self-motivation and going above and beyond minimum requirements

Day to Day Responsibilities:

Package Development
Lead development and optimization of secondary & tertiary packaging for biologics, sterile injectables, and combination products.
Create novel designs and maintain component specifications for 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 manufacturing process engineering studies

Ensure compliance with global regulatory expectations (FDA, EMA, ISO, USP).

Prepare and review packaging documentation for regulatory submissions.

Support technology transfer, scale-up, and readiness activities at client manufacturing sites and contract manufacturing locations.

Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.

Partner with suppliers and Supply Chain to qualify components, assess supplier capability, manage change notifications and implement new material technologies.

Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and traceability requirements.

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.

Excellent communication skills and ability to collaborate and influence across functions.

Attention to detail with a mindset of getting things done correctly and robustly the first time.

Ability to work onsite at client’s Thousand Oaks campus.

Preferred Qualifications:
Master’s degree in Engineering or related field.

Experience with combination products, injection devices, and cold-chain distribution systems.

Experience with structural design, FEA and utilization of artificial intelligence.

Experience with GMP, GDP, GD&T principles.

Red Flags:
Long-winded, unconvincing answers to questions.
Low energy.
No Packaging Engineer Degrees (We’re Trying Different Degrees).

Interview Process:
Up to 3 interviews
1st round with manager
2nd & 3rd rounds will be panel interviews with 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 review other opportunities on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone who may be interested.

Senior Process Engineer – Packaging Equipment, commercial GMP Final Drug Product operations (JP15195) - New Albany, Ohio

Mon, 06 Apr 2026 14:13:42 GMT

Job Title: Senior Process Engineer – Packaging Equipment, commercial GMP Final Drug Product operations (JP15195)
Location: New Albany, OH. 43054
Employment Type: Contract
Business Unit: Process Development
Duration: 18+ months with possible extensions and/or conversion to permanent
Posting Date: 3/6/2026
Pay Rate: $45 - $50/hour W2
Notes: Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift / Weekend. 10% travel required - Must be able to travel internationally for work (Europe/Canada)

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

Ideal Candidate: Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience, technical writing & Document management system experience - KNEAT or Veeva highly prefer.

Job Description:
The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio .
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 ~10% 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

Qualifications
- Basic (Education & Experience)
- 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
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

Why is the Position Open?
Planned project

Top Must Have Skills:

Equipment & Manufacturing Support
Provide on-site support for GMP packaging and device assembly operations
Troubleshoot equipment issues and improve reliability/performance
Support automated and semi-automated assembly lines
Monitor and trend equipment performance metrics
Process Improvement & Optimization
Identify and implement process improvements to increase throughput and efficiency
Analyze manufacturing data to drive continuous improvement initiatives
Optimize packaging line capacity and performance
Documentation & Quality Systems
Write, review, and manage GMP documents (protocols, reports, procedures)
Own and manage deviations, CAPAs, and change controls
Maintain and update the site master validation plan
Use systems like KNEAT or Veeva for document control
Validation & Technical Projects (CQV)
Lead or support commissioning, qualification, and validation (CQV) activities
Support tech transfer of products into the Ohio site
Ensure equipment and processes meet regulatory and quality requirements
Cross-Functional Collaboration
Work with manufacturing, quality, engineering, and external vendors
Coordinate with commercial and clinical teams
Communicate progress on technical milestones and projects
Project & Vendor Management
Support equipment-related projects and timelines
Interface with equipment suppliers/vendors for troubleshooting and improvements
Contribute to standardization efforts across sites
Flexible Operations Support
Work swing shifts (day/night/weekend as needed)
Provide support based on production demands
Occasional travel (~10%)

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

Red Flags:
1. Weak or No GMP Experience
2. Lack of Hands-On Equipment Experience
3. Poor Technical Writing / Documentation Skills
4. No Process Improvement Mindset
5. Limited Ownership or Leadership
6. Weak Communication & Cross-Functional Skills
7. Inflexibility with Schedule or On-Site Work

Interview process:
Virtual Interview, 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

Facilities Project Engineer, Biotech GMP Facilities (JP15189) - Holly Springs, NC

Mon, 06 Apr 2026 12:23:28 GMT

Job Title: Facilities Project Engineer, Biotech GMP Facilities (JP15189)
Location: Holly Springs, NC. 27540
Employment Type: Contract
Business Unit: CPEC
Duration: Initial 8 months with likely extensions and/or conversion to permanent
Posting Date: 04/6/2026
Pay Rate: $35 - $38/hour W2

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

Job Description:
Looking for more of a junior resource with ideally 4-5+ years of experience.
Open for candidates with experience with project engineering and coordination experience.

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for facilities related scope. Employ 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. Participate and be a delegate in commissioning walks for the facilities management team. Skills: self-started, ability to communicate effectively, manage tasks to completion. Experience with facilities management and projects is a must.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:
- Proactive
- Communication Skills
- Engineering problem solving
- Commissioning experience

Day to Day Responsibilities:

Work closely with Facilities Sr Mgr. and Facilities Mgr. to work through commissioning and start up of new Amgen facilities in North Carolina
Participate in walkdowns
Proactive problem solving in communication with facilities management team
Owner of change controls / deviations / CAPAs
Provide support for Inspection readiness

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:
Likes to work in silos - Needs to be comfortable working in a team environment.
Can't execute instructions from supervisor
Not open to learn and work in a multidisciplinary / multicultural environment

Interview process:
Two interviews: One screening with hiring manager and one panel interview (2-3 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.

Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200) - Thousand Oaks, CA

Fri, 03 Apr 2026 11:59:47 GMT

Job Title: Drug Product Visual Inspection Process Development Engineer (Aseptic Fill/Finish) - (JP15200)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 1+ year with likely extensions and/or conversion to permanent
Posting Date: 04/3/2026
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

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

Top Must Have Skills:
1) Experience with Visual Inspections
2) Defect Standard Creations
3) Biosafety Lab Aseptic Technique

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.

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.

Key responsibilities include:

Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect standards and panels, establishment of GMP procedures related to operations)
Supports the establishment of robust tactical and strategic objectives related to visual inspection
Implements and documents off-line and on-site drug product characterization studies
Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
Support one or more clinical and commercial process introductions or process transfers into company manufacturing network

Preferred Qualifications

3+ years of experience within the pharmaceutical/biotechnology industry
Experience in development/characterization of drug product unit operations, especially visual inspections
Understanding of process related stresses that impact the quality and stability of biologics
Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)
Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing
Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
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.
Laboratory or pilot plant experience with process equipment

Why is the Position Open?
Supplement additional workload on team

Day to Day Responsibilities:

Supports ongoing hands-on lab-based development in visual inspection process development (i.e. development and maintenance of defect standards and 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.

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 Lab Experience
Not good with hands-on work.

Interview process:
2 Phone interviews.
1st 30 minutes with hiring manager
2nd 30 minutes 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.

AI Data Integration Engineer (RAG Systems) - Hybrid (JP15177) - Cambridge, MA

Wed, 01 Apr 2026 12:41:32 GMT

Job Title: AI Data Integration Engineer (RAG Systems) - Hybrid (JP15177)
Location: Cambridge, MA 02138
Employment Type: Contract
Business Unit: ETA Drug Substance
Duration: 1+ year with likely extensions and/or conversion to permanent
Posting Date: 4/1/2026
Pay Rate: $36 - $41/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.

Job Details:
Role: Engineering Technical Authority (ETA) - AI Accelerator (Contract Worker). Hybrid, 8-5 local time

Enable and accelerate the effective use of AI-enabled assistants within ETA global engineering by supporting exploration, integration, and adoption of AI capabilities aligned to ETA workflows. The intent is to increase engineering efficiency, shorten design timelines, and reduce design costs through practical application of AI support.

Primary function:
Accelerate ETA adoption of AI-enabled assistants by translating engineering needs into practical use cases, enabling access to authoritative engineering data, and increasing hands-on engagement across ETA.

Why is the Position Open: Planned Project

Top Must Have Skills:

1-2 years in data engineering role post graduation
Awareness of current AI trends, tools, and release timing
Strong working understanding of RAG-based systems, particularly data ingestion, retrieval quality, and response grounding.

Day to Day Responsibilities:

Develop and evolve AI-enabled assistants aligned to ETA engineering workflows.
Help ETA implement connections to engineering systems and accelerate their use, building integrations where needed and under direction of the Digital EOS function.
Support development and testing of APIs, connectors, and data access patterns.
Hold regular AI office hours to accelerate adoption, experimentation, and learning.
Capture insights and emerging opportunities to guide future investment and prioritization.

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:
- Poor communication skills
- Inability to work without direction

Interview process:
I will perform a 30-minute screening interview as the hiring manager (Video screening)
I will request 1-3 additional 30min interviews with my team members/management. (Video)

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 Senior, DeltaV/Rockwell PLCs/GMP - (JP15196) - Thousand Oaks, CA

Wed, 01 Apr 2026 10:41:59 GMT

Job Title: Automation Engineer Senior, DeltaV/Rockwell PLCs/GMP - (JP15196)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Advanced Technology and Automation
Duration: 3 years
Posting Date: 05/13/24
Pay Rate: $42 - $52/hour W2 with benefits
Notes:
Shift/Schedule: Monday - Friday - 8am - 5:00pm
Must be willing to be on call - After hours support once every 4 weeks (Manufacturing calls that come in, resolve any issues that come up) - 1 call per week that their own (call is 2 hours)

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

Job Description:
External Automation Engineer based in Thousand Oaks, California to augment our MCS F&E Automation team. This role will support ongoing biological processes by updating, maintaining, and improving DeltaV automation systems, and providing critical site support. The successful candidate must exhibit sound analytical thinking and problem-solving skills, exemplary communication and collaboration, and operational excellence. A proven ability to work in cross-functional teams is critical for this role.

Preferred Qualifications:

Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech
Engineering.
Extensive understanding and background in programming, design, installation and lifecycle
management of manufacturing process controls, automation and field instrumentation
technologies.
Demonstrated hands-on experience in developing process control strategies for New
Product Introduction and New Technology Deployment for Clinical and Commercial Drug
Substance Plant Operations.
Direct knowledge of Automation design, experience in process control engineering and
troubleshooting with GMP biopharmaceutical production facility equipment/systems such
as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration,
and integrating various OEM automation software.
Demonstrated experience with continuous improvements resulting in enhanced safety,
system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.)
related to Drug Substance Plant Operations.
5+ years’ combined experience with the following:
○ 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 and ability to perform advanced troubleshooting activities
with IS.
○ System Integration using OPC, Foundation Fieldbus, Profibus,
and DeviceNet technologies.
○ Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.
Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost
estimate development, business case development, detailed design, engineering and
validation documentation and project execution.
The ideal individual must be a self-directed team player ready to mentor and develop
engineering staff and embrace a team-based culture that relies on collaboration for
effective decision-making.
Strong leadership, technical writing, and communication/presentation skills.
Ability to perform independently, self-motivated, organized, able to multi-task in project
environments, and skilled in communication, facilitation, and collaboration.

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

Top Must Have Skills:
- Working knowledge of Delta V, Rockwell PLCs, automation comm protocols.
- Working experience with GMP manufacturing
- Strong communication/collaboration skills with broad audience.
- Pharma experience and or Chemical Engineering knowledge – preferred

Day to Day Responsibilities:

Develop and maintain process control automation solutions utilizing DeltaV Distributed
Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine
Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Lead and support functional area projects focused on improving process
equipment/utilities/facilities -to- large/sophisticated capital projects to integrate new drug
substance manufacturing technologies into clinical/commercial facility.
Lead/support technical root cause analysis, incident investigations, and troubleshooting on
process control issues related to plant operations.
Lead 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 as
applicable.
Lead and Manage Day-to-day Operational Support including:
○ 24 x 7 Onsite/On Call: Day to Day Operational Support
○ Troubleshooting Support to Mfg. Operations
○ Automation System Administration
○Automation System Operating Systems (OS) and HotFix assessments
and rollout
○ Daily manufacturing and engineering work center team meetings
○ Preventative and corrective maintenance
○ Automation System spare parts management
○ Purposeful Presence on the Floor (PPoF)
Provide Continuous Improvement initiatives including
○ Safety, Productivity and Reliability Improvements
Automation Business Process Improvements including departmental
Standard Operating Procedures (SOP)
○ Maintain Data Integrity Assessments with the current company and
Industry standards
○ Collaborate with Drug Substance Plant network to enhance the automation design
for Drug Substance Plant Operations

Interview process:
Virtual Interviews
1. Initial interview with hiring manager
2. Second interview team panel
3. Optional third interview with leadership

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 C&Q Validation Engineer – GMP Analytical & Process Equipment- (JP15147) - Thousand Oaks, CALIFORNIA

Tue, 31 Mar 2026 16:03:06 GMT

Job Title: Senior C&Q Validation Engineer – GMP Analytical & Process Equipment- (JP15147)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Engineering Systems
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/31/26
Pay Rate: $60 - $65/hour W2
Notes: Only qualified candidates need apply. On site at least 3 days weekly 8-5

3 Key Consulting is hiring a Senior C&Q Validation Engineer – GMP Analytical & Process Equipment for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities. Responsibilities include generating/reviewing/executing C&Q protocols, plans, and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities. Key skills include:

Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV role.
Knowledge of cGMP commissioning/qualification/validation practices.
Familiarity with Kneat Gx Platform or other digital C&Q systems.
Experience working with cross-functional stakeholders.
Knowledge of quality assurance principles.
Experience working within project teams and multiple projects in parallel.
Effective communication skills, both verbal and written.
Able to think analytically with the ability to resolve issues.
Able to manage own time efficiently.

Why is the Position Open?
Supplement additional workload on team

Top Must Have Skills:

Experience in commissioning/qualification/validation
Experience in a GMP environment
Experience with analytical instruments (Benchtop laboratory equipment)

Day to Day Responsibilities:

Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
Work with project teams to develop the commissioning and qualification strategy and document in qualification plans.
Generate/evaluate qualification/validation protocols including IQ, OQ, FT, PQ protocols and final reports for new or modified GMP analytical and process equipment, utilities, and facilities.
Execute IQ, OQ, FT, PQ protocols, which may involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP analytical and process equipment, utilities, and facilities.
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.
Develop and/or execute FAT/SAT and other commissioning activities for new GMP systems in collaboration with both internal and external partners.

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

Red Flags:
Short tenures at previous jobs (-2 years), not local and not willing to relocate

Interview process:
1 video conference interview (Teams), potential follow-up 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 Drug Delivery Device / Technical Transfer (JP15161) - New Albany, Ohio

Thu, 26 Mar 2026 16:48:24 GMT

Job Title: Engineer – Biotech Drug Delivery Device / Technical Transfer (JP15161)
Location: New Albany, OH. 43054
Business Unit: Manufacturing Science & Technology
Employment Type: Contract
Duration: 2+ year with likely extensions and/or conversion to permanent
Posting Date: 03/26/2026
Pay Rate: $32 - $37.50/hour W2 with Benefits
Note: Onsite Ohio - 5 days a week

3 Key Consulting is hiring Engineer – Drug Delivery Combination Product for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Ideal Candidate: B.S. 3+ YOE, Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products. Engineering Background.
Skills: Strong English written and verbal communication skills, MS Office, Smartsheet (project scheduling software), project management experience in a supporting role.

Position Overview:
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 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.

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 commercialization framework.
Program and Project Management skills (experience with MS Project, Smartsheet, 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.

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

Top Must Have Skills:
- Process Engineer
- must have combination product
- Tech Transfer Experience

Day to Day Responsibilities:
Manage tech transfer projects from E2E for NPIs coming to AOH Site

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:
Not looking for a DS or DP Engineer
No combination product experience

Interview process:
Video conference with:
Manager (1:1) - 30 min
Interview Panel 1: 45 min
Interview Panel 2: 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.

Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180) - Holly Springs, NC

Thu, 26 Mar 2026 14:44:42 GMT

Job Title: Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180)
Location: Holly Springs, NC. 27540
Employment Type: Contract
Business Unit: NPI and MFG Systems
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/26/26
Pay Rate: $55 - $65/hour W2
Notes: Only qualified candidates need apply. Fully onsite - 8-5 Monday - Friday - occasional availability needed outside normal hours such as nights or weekends.

3 Key Consulting is hiring a Senior Cleaning Validation Engineer (On-Floor Execution Lead) for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Our ideal candidate will have 8+ YOE and must have field execution experience.

Lead the execution of all Cleaning Validation activities (CV/SIP PQ/CHT/SHT studies), including protocol generation, field execution, data retrieval/verification, sample management following a Lifecycle Approach and using Kneat.
Supports non-traditional work schedule based on project and business needs
Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
Design and develop cleaning procedures for new products and manufacturing equipment.
Conduct cleaning validation studies, including sampling, testing, and data analysis.
Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
Trains manufacturing and QC/QA personnel on cleaning validation documentation.
Support the development of the periodic cleaning monitoring program.
Benchmark against the broader internal network and external industry with the aim of achieving best-in-class standards and practices, expands and shares knowledge throughout the network to achieve excellence in Cleaning Validation.
Support assigned teams as required to provide Cleaning Validation guidance.
Review and coordinate Change Controls with Cleaning Validation impact as required.
Lead and support continuous improvement by identifying and implementing projects to eliminate waste and improve cleaning times through CIP Optimization.
Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures

Why is the Position Open?
Planned Project

Top Must Have Skills:

Proficient with KNEAT
Demonstrated track record of leading and executing cleaning validation studies and knowledge of CV lifecycle
Proficient with CIP/SIP cycles and process understanding to drive execution of validation deliverables
Willingness to work non-traditional shift, off shift, weekends and holidays to support cleaning validation activities as needed
Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
Effective communication and collaboration skills to work across teams.
Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
Field execution experience
Nice to have: PM experience, troubleshooting deviation CAPA change control management, ability to support investigational studies as needed.

Day to Day Responsibilities:
See job description above.

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

Red Flags:

No track record of field execution and managing high-volume of validation deliverables
Not willing to support non-traditional work hours
Not familiar with KNEAT

Interview process:
1st virtual initial screening, 2 panel interviews (in-person) which will take place same day.

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.

Packaging Engineer – Drug Product Packaging & Verification Testing (JP15184) - New Albany, OH

Thu, 26 Mar 2026 10:33:38 GMT

Job Title: Packaging Engineer – Drug Product Packaging & Verification Testing (JP15184)
Location: New Albany, OH. 43054
Employment Type: Contract
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/26/26
Pay Rate: $32 - $37.50/hour W2
Notes: Only qualified candidates need apply.

3 Key Consulting is hiring a Packaging Engineer – Drug Product Packaging & Verification Testing for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Position Overview:
This role supports new drug product packaging initiatives, with a primary focus on packaging verification testing at a newly established site dedicated to packaging development and testing. We are seeking a qualified Packaging Engineer with a strong foundation in packaging principles and hands-on testing experience. Candidates from the pharmaceutical and biotech industries are preferred; however, individuals with relevant experience in food or consumer products packaging will also be considered.

Ideal Candidate Profile:
The ideal candidate will possess a degree in Packaging (or closely related field) along with demonstrated packaging engineering experience. Proficiency in AutoCAD and Adobe Illustrator is required. Candidates should have approximately 5+ years of experience in pharmaceutical packaging and must be willing to relocate to the New Albany, OH area at their own expense.

Role Summary:
This external contractor position reports to the Packaging Engineering group within Combination Product Operations (CPO) and is based in New Albany, OH. The role supports global supply, new product introductions, partnerships/acquisitions, and combination products. The selected candidate will apply engineering principles to the design, qualification, and implementation of primary and secondary packaging components, as well as associated systems including documentation, equipment, and processes.
A strong understanding of healthcare packaging materials is essential, including structural components such as bottles, labels, trays, lidding materials, leaflets, paperboard, sterile barrier systems, and corrugate. The role may include opportunities for entry-level leadership responsibilities and requires strong organizational, project management, technical problem-solving, and communication skills. The ability to collaborate cross-functionally and adapt in a fast-paced, evolving environment is critical for success.

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

Top Must Have Skills:

Packaging education and experience (minimum bachelors degree)
AutoCAD and illustrator software
5 YOE in pharmaceutical or related industry packaging.

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
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

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

Red Flags:
No packaging experience

Interview process:
Video conference 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 Product Process Development & Technology Transfer - (JP15153) - Thousand Oaks, CALIFORNIA

Mon, 23 Mar 2026 12:03:15 GMT

Job Title: Engineer, Drug Product Process Development & Technology Transfer - (JP15153)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/23/26
Pay Rate: $36 - $41/hour W2
Notes: Only qualified candidates need apply.

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

Job Description:
Bachelor's degree with at least 1 year of Industry Experience (not internship or similar).

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 products to the aseptic fill finish manufacturing plants 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. 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:
- Knowledge of and hands-on experience with various drug product technologies
- 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

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

Preferred Qualifications:
• 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
- Not being a team player
- No industry experience

Interview process:
- Hiring Manager
- Panel Interview
- 1:1 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.

Engineer, Cleaning Validation Specialist- (JP15151) - Holly Springs, NC

Thu, 19 Mar 2026 13:38:58 GMT

Job Title: Engineer, Cleaning Validation Specialist- (JP15151)
Location: Holly Springs, NC. 27540
Employment Type: Contract
Business Unit: NPI and MFG Systems
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/19/26
Pay Rate: $44 - $47.50/hour W2
Notes: Only qualified candidates need apply. Standard Hours - hours may vary to support manufacturing (early/later shifts, possible weekends)

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

Job Description:
Our ideal Candidate: 5+ YOE with a B.S. in Science, Engineering, and Pharmacy areas.

This is a Cleaning Validation Specialist position. Candidate will coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.

Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies
Supports non-traditional work schedule based on project and business needs
Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program
Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
Proficient with KNEAT execution
Design and develop cleaning procedures for new products and manufacturing equipment.
Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
Supports the periodic review of cleaning validation studies.
Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
Trains manufacturing and QC/QA personnel on cleaning validation documentation.

Why is the Position Open?
Planned Project

Top Must Have Skills:

Proficient with KNEAT or similar programs.
Strong understanding of GMPs and global regulatory expectations.
Ability to interpret equipment design, P&IDs, and process flow diagrams.
Excellent technical writing and documentation skills.
Strong analytical and problem solving abilities.
Effective communication and cross-functional collaboration.
Ability to work independently and manage multiple priorities.

Day to Day Responsibilities:
Expectation is that the candidate will support execution and management of the CV lifecycle.

Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies
Supports non-traditional work schedule based on project and business needs
Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program
Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
Proficient with KNEAT execution
Design and develop cleaning procedures for new products and manufacturing equipment.
Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
Supports the periodic review of cleaning validation studies.
Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
Trains manufacturing and QC/QA personnel on cleaning validation documentation.

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:
Project Management experience.

Red Flags:
Lack of experience on the floor or supporting field execution
Inability to support non-traditional work schedule

Interview process:
First round virtual screening 2nd round panel 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 Process Development and Tech Transfer Project Support - (JP15165) - Thousand Oaks, CA

Wed, 18 Mar 2026 15:54:05 GMT

Job Title: Engineer, Drug Product Process Development and Tech Transfer Project Support - (JP15165)
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: 03/18/2026
Pay Rate: $36 - $41/hour W2 With Benefits
Notes: Onsite 8AM -5PM

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:
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:

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.
Post graduation experience required.

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

Interview process:
1. short phone screen with manager
2. panel interview with co workers virtual
3. possible final interview with associate director of organization 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 Senior, Synthetic Kilo Laboratory and Analytical Chemistry Support - (JP15156) - Thousand Oaks, CA

Wed, 18 Mar 2026 14:40:15 GMT

Job Title: Engineer Senior, Synthetic Kilo Laboratory and Analytical Chemistry Support - (JP15156)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: DST Synthetics
Duration: 1+ year(s) (with likely extensions and/or conversion to permanent)
Posting Date: 03/18/2026
Pay Rate: $46 - $52/hour W2 With Benefits
Notes: 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:
T 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.

Packaging Engineer – Drug Product / Secondary Packaging & Verification - (JP15116) - New Albany, OH

Wed, 18 Mar 2026 12:05:44 GMT

Job Title: Packaging Engineer – Drug Product / Secondary Packaging & Verification - (JP15116)
Location: New Albany, OH. CA. 43054
Employment Type: Contract
Business Unit: Commercial Drug Product
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/18/26
Pay Rate: $34.00 - $37.50/hour W2
Notes: Only qualified candidates need apply. 100% onsite. Requires flexibility across multiple shifts (1st, 2nd, or 3rd), though it will predominantly operate Monday through Friday, 8:00 AM to 5:00 PM.

3 Key Consulting is hiring a Packaging Engineer – Drug Product / Secondary Packaging & Verification for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
This role supports new drug product packaging initiatives, with a focus on packaging engineering and packaging verification testing. Candidates with relevant experience in industries such as food, consumer products, cosmetics, or home fragrance are also encouraged to apply. The position may require flexibility across multiple shifts (1st, 2nd, or 3rd), though it will predominantly operate Monday through Friday, 8:00 AM to 5:00 PM. Candidates must be open to adjusting their schedule as needed to support business demands.

This position reports into the Packaging Engineering group under Combination Product Operations (CPO) at our client’s New Albany, OH. facility. The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position utilizes physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes.

A knowledge of common materials utilized in pharmaceutical packaging is key to this role. This role will support our client’s manufacturing network by applying broad knowledge of pharmaceutical packaging operations, equipment, devices, and materials to develop the industry’s best combination product assembly and packaging processes.
Understanding of packaging manufacturing equipment and processes and how materials interact with these is essential to the position.

The job will require both planning and technical support of complex projects supporting a new site start-up. This role will be responsible for planning and overseeing projects to ensure on-time completion, establish priorities, report project status updates, and manage project dashboards for the Secondary Packaging Engineering team.

This role will 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 role requires management, problem solving, communication (written and verbal), and organizational skills, and the ability to work in teams and adapt to rapidly changing environment. Project Management experience supporting implementation of commercial packaging configurations is preferred. Candidate must possess extensive knowledge and expertise in the use of project management methodologies and tools.

Why is the Position Open?
Unplanned Project

Top Must Have Skills:

Excellent technical communication
Ability to manage multiple priorities
Excel in high pressure fast paced environment and professional

Day to Day Responsibilities:

- Project Management of entry level engineers and contingent workers
- Evaluation, recommendation and selection of new secondary packaging materials for pharmaceutical products
- Assessing complex problems relating to materials, recommending and implementing solutions
- Write test protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials
- Write Technical Specifications
- Representing Final Product Technologies as required
- Technology transfer from clinical to commercial or from site to site for packaging components and equipment processes
- Establish priorities to ensure all projects are managed within expected due dates
- Lead and present new packaging ideas, concepts and design ideas to the Product Development team
- Ensures cGMP and regulatory compliance are met
- Ensures that change control procedures are followed working with QA and Regulatory to implement changes
- Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc.) as needed
- Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities

Basic Qualifications:

- Doctorate degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field, OR
- Master’s degree in in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 5 years of Packaging Engineering experience, OR
- Bachelor’s degree in in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 8 years of Packaging Engineering experience

Preferred Qualifications:

Master’s degree in Packaging Engineering, Materials Science, Pharmacology, Mechanical Engineering, Chemical Engineering, or related engineering field
7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industry

Leading technical teams
Independent thinker with demonstrated skills working in teams or leading technical project teams
Strong Interpersonal and communication skills
Project management
Ability to manage competing priorities

Red Flags:

Lack of strong communication skills
Lack of ability to learn new systems (SAP, PLM, Smartsheet, etc.)
Lack of flexibility

Interview process:
Virtual Interviews:

1:1 with Sr Manager
Group Interview with Team Members

Engineer, Automation (PLC/HMI/SCADA), Operational Support – Biotech (JP15150) - Thousand Oaks, CA

Tue, 17 Mar 2026 11:44:10 GMT

Job Title: Engineer, Automation (PLC/HMI/SCADA), Operational Support – Biotech (JP15150)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Advanced Technology & Automation
Duration: 3 years with possible conversion to permanent
Posting Date: 03/17/2026
Pay Rate: $36 - $42/hour W2 with benefits

3 Key Consulting is hiring an Engineer, Automation (PLC/HMI/SCADA), Operational Support for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description & Responsibilities:

Develop and maintain process control automation solutions utilizing Rockwell and Siemens Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Support functional area projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
Lead/support technical root cause analysis, incident investigations, and solving problems related to process control issues within plant operations.
Lead and support new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet company’s goals
Maintain Data Integrity Assessments with the current company and Industry standards
Collaborate with Drug Product Plant network to improve the automation design for ATO Drug Product Plant Operations.
Own and close deviations/CAPA within agreed upon timelines.

Day-to-day Operational Support including:

Participate in the 24 x 7 Onsite/On Call rotation.
Troubleshooting Support to Mfg. Operations
Automation System Administration
Automation System Operating Systems (OS) and HotFix assessments and rollout
Daily manufacturing and engineering work center team meetings
Preventative and corrective maintenance
Automation System spare parts management
Drive true root cause investigations and resolutions by interfacing with equipment Vendors.
Business Process Improvements including departmental Standard Operating Procedures (SOP)

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

Top Must Have Skills:

Bachelors degree in Engineering
Programming in Python
Familiarity with PLCs

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

Interview process:
Video 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.

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.

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.

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 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.

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 – 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)

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.

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, 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.

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

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.

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.

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.

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.

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

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.

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

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.

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.

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

Manufacturing Engineer (JP12913) - Thousand Oaks, CA

Tue, 18 Jun 2024 14:57:11 GMT

Job Title: Manufacturing Engineer (JP12913)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities and Engineering Drug Substance Supply Group
Employment Type: Contract
Duration: 5+ months (with likely extensions for 2025)
Rate: $38 - $42 /hour
Posting Date: 6/18/2024.
Notes: Only qualified candidates need apply. Fully onsite at ATO - no opportunity for remote, Full time onsite support in required. Standard business hours, some possibility for overtime

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

Job Description:
Looking for industry experience as a manufacturing engineer. This engineering position supports manufacturing activities associated with manufacturing process equipment at our client’s Thousand Oaks,CA facility. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop, improve and oversee the operation and reliability of equipment. The Engineer role will provide direct engineering technical support as follows:

Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the process equipment. This may include development of rationale 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.
Be individually accountable for the verification deliverables.
Assist in the identification of critical quality parameters and process attributes for new equipment.
Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Assist in development and review of User Requirements Specifications (URS).
Suggest design modifications to address risks and design in quality and safety.
Develop or oversee development of commissioning and function test plan for any equipment modifications and acquisition in line with CQP, Automation Systems, SOPs, and standards.
Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout.
Ensure safety during commissioning, validation, maintenance and manufacturing activities.
Monitor systems to identify performance risks and implement risk reduction strategies.
Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.
Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
Lead and provide ad hoc technical support and guidance in a timely manner for manufacturing and maintenance on equipment troubleshooting.
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Identifying reliability improvements for assigned equipment to improve equipment uptime.
Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time.
Provide concise and clear documentation for actions taken on systems.

Top Must Have Skill Sets:

Engineering and technical background (process equipment, troubleshooting, data driven tech skills)
Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering
Team work experience

Day to Day Responsibilities:

Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the process equipment. This may include development of rationale 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.
Be individually accountable for the verification deliverables.
Assist in the identification of critical quality parameters and process attributes for new equipment.
Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Assist in development and review of User Requirements Specifications (URS).
Suggest design modifications to address risks and design in quality and safety.
Develop or oversee development of commissioning and function test plan for any equipment modifications and acquisition in line with CQP, Automation Systems, SOPs, and standards.
Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout.
Ensure safety during commissioning, validation, maintenance and manufacturing activities.
Monitor systems to identify performance risks and implement risk reduction strategies.
Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.
Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
Lead and provide ad hoc technical support and guidance in a timely manner for manufacturing and maintenance on equipment troubleshooting.
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Identifying reliability improvements for assigned equipment to improve equipment uptime.
Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time.
Provide concise and clear documentation for actions taken on systems.

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
Basic technical report writing and presentations
Verbal communication
Personal Organization
Dealing with and managing change
Technical (Equipment Specific)
Analytical Problem Solving
Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)
Specialized equipment/process expertise
Ability to handle multiple projects/troubleshooting at the same time
Schedule development, facilitation and collaboration
Basic project management, project completion and follow-up
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Project Cost development
Conflict Resolution
Customer service in a technical setting
Management of contractors and vendors.
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

Preferred Qualifications:

Bachelor's degree in engineering-related field
5+ years of relevant work experience with 3+ years’ experience in operations/manufacturing

environment

Direct experience with 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

Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production
facility equipment/systems such as cell culture reactors, chromatography, filtration, as well as other

equipment needed to support these processes such as autoclaves, clean in place (CIP) systems,
washers, clean steam, etc.

Process automation knowledge – understanding of automation infrastructure, current technologies,

and automation project execution / verification.

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

Red Flags:

No work experience
No engineering or technical experience
No collaboration experience
No work gap of more than 3 months

Interview Process:
1-2 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.

Senior Engineer, Pharma Equipment/Facilities Management (JP12841) - Thousand Oaks, CA

Mon, 10 Jun 2024 13:51:30 GMT

Job Title: Senior Engineer, Pharma Equipment/Facilities Management (JP12841)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Substance Supply
Employment Type: Contract
Duration: 6+ months with possible extension or conversion to FTE
Rate: $45 - $50 / hr.
Posting Date: 06/10/2024.
Notes: Fully onsite must be local, not looking for relocation job seekers.
Standard business hours, some possibility for OVT

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

Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering and manufacturing background.

Job Description:
This engineering position supports manufacturing activities associated with manufacturing equipment and facilities at Thousand Oaks, CA. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.

The Engineer role will provide direct engineering technical support as follows:

Be individually accountable for the verification deliverables
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).
Suggest design modifications to address risks and design in quality and safety.
Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.
Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout
Ensure safety during commissioning, validation, maintenance and manufacturing activities
Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Responsible for equipment troubleshooting in a timely manner.
Identifying reliability improvements for assigned equipment to improve equipment uptime.
Support Lean Transformation and Excellence in Operations 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 concise and clear documentation for actions taken on systems

Demonstrated skills in the following areas:

Problem solving and applied engineering.
Basic technical report writing and presentations
Verbal communication
Personal Organization
Dealing with and managing change
Technical (Equipment Specific)
Analytical Problem Solving
Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)
Specialized equipment/process expertise
Ability to handle multiple projects at the same time
Schedule development, facilitation and collaboration
Basic project management, project completion and follow-up
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Negotiation, persuasion and facilitation Collaboration
Project Cost development
Conflict Resolution
Customer service in a technical setting
Management of contractors and vendors.
Flexibility to work off-hours and fully on-site

Basic Qualifications:
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience

Top Must Have Skill Sets:

Engineering and technical background (process equipment, troubleshooting, data driven tech skills)
Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering
Team work experience
Pharmaceutical equipment management background

Employee Value Proposition:
Possible FT opportunity if goes well, contract will continue past current end date if things are going well (the business need will be there)

Red Flags:
No work experience
No engineering or technical experience
No collaboration experience
No work gap of more than 3 months

Interview Process:
WebEx interview with a panel of 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.

Associate Engineer, Biotech - Thousand Oaks, CA

Mon, 27 May 2024 17:16:50 GMT

Job Title: Associate Engineer, Biotech
Location: Thousand Oaks, CA.
Employment Type: Contract
Duration: 1+ year(s) (with possible extensions)
Rate: $30 - $34/hour W2
Posting Date: 05/21/2024

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

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

Requirements:

Some industry experience through internship 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

Top 3 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

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.

Associate Engineer Packaging (JP12188) - New Albany, OH

Thu, 18 Jan 2024 15:54:54 GMT

Job Title: Associate Engineer Packaging (JP12188)
Location: New Albany, OH. 43054
Business Unit: Design Team Packaging Group
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $27 - $30/hour W2
Posting Date: 01/18/2024
Notes: Onsite but can work from home occasionally.

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

We are looking for a packaging engineer and experience with Adobe Illustrator for making templates for packaging components.

Job Description:
This position reports into the Packaging Engineering group under Combination Product Operations (CPO) in Thousand Oaks, CA (ATO). 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 a rapidly changing environment.

Top Must Have Skill Sets:

Ability to use Adobe Illustrator Software to create technical templates based on packaging specification drawings.
Experience with or familiarity of Packaging Engineering job function
Demonstration of being proactive and have the ability to multi-task
(see red flags also)

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 and 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:

Independent thinker with demonstrated skills working in teams or leading project teams
Strong Interpersonal and communication skills
Bachelor degree OR Associate degree and 4 years of experience.

Preferred Qualifications:

MS or BS Packaging, Mechanical Engineering, Chemical Engineering, Life Sciences or related field
0 to 3 years general packaging/engineering experience

Why is the Position Open?
Supplement additional workload on team

Red Flags:

Not familiar with client or what we do (Can the candidate name a client product and understand what it is used to treat?)
No understanding of what Packaging Engineers do
Lack of motivation
No Adobe experience

Interview Process:
WebEx Video Call - Will be screened by team member and then the hiring manager

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, Medical Device Test Design and Execution (JP12062) - Thousand Oaks, CA

Tue, 05 Dec 2023 18:03:57 GMT

Job Title: Engineer, Medical Device Test Design and Execution (JP12062)
Location: Thousand Oaks, CA. 91320
Business Unit: Systems Engineering
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $37 - $41/hour W2
Posting Date: 12/05/2023
Notes: Only qualified candidates need apply. Onsite in Thousand Oaks Mon through Fri with need to 6:00 AM calls to support Demark time zone twice a week. Time on campus will be lab work will be working with lab equipment. There is hybrid opportunity once candidate is seen to be self-sufficient.

3 Key Consulting is recruiting an Engineer, Medical Device Test Design and Execution for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:
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 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.

Our ideal candidate will have familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.

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.

Day to Day Responsibilities:
This position includes three primary responsibilities:

(50%) 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)
(30%) 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
(20%) Statistical data analysis of test results to be included in technical reports.

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

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

Red Flags:

Candidates with Software or Electrical engineering these are NOT desired for the role.
No lab experience
Different industry
No mechanical or medical device experience.
Spelling and grammatical errors in resume. Frequent short job durations and job hopping.

Interview Process:

Three to four one-on-one, 30 minute, remote interviews with various team members.
Able to start interviewing immediately.

Engineer Senior, Drug Delivery Medical Device Biocompatibility (JP12000) - Thousand Oaks, CA

Thu, 30 Nov 2023 17:33:54 GMT

Job Title: Engineer Senior, Drug Delivery Medical Device (JP12000)
Location: Thousand Oaks, CA. 91320
Business Unit: Design Control
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $45 - $50/hour W2
Posting Date: 11/30/2023
Notes: Only qualified candidates need apply.

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

Job Description:
The ideal candidate for this role is a highly qualified professional with a Bachelor's degree in Science or Engineering and a minimum of 5 years of experience in the medical device industry. They possess a robust understanding of ISO 10993 biocompatibility standards, particularly parts 3, 4, 6, 7, 11, and 18, along with expertise in drug/device combination product design and development. With a solid grasp of Medical Device Regulations such as 21CRF820 and ISO 13485, excels in assessing and ensuring regulatory compliance. Excellent communication skills, both written and verbal, enable effective coordination with diverse stakeholders, and they exhibit strong problem-solving abilities. A team player with meticulous attention to detail, thrives in a deadline-driven environment, managing multiple projects while maintaining cross-functional alignment and presenting detailed information to governance bodies.

Top Must Have Skill Sets:
1) Expertise in ISO 10993 biocompatibility standard, especially parts 3,4,6,7,11, and 18.
2) Familiarity with Medical Device Regulations (21CFR820 and ISO 13485),
3) Good communication skills to coordinate standard assessments.

Day to Day Responsibilities:
• Detailed technical assessment of new/revised external requirements.
• Coordinate the assessment of changes to external requirements in collaboration with other Subject Matter Experts.
• Conduct document management system search for impacted records and disposition documents accordingly.
• Communicate outcome of technical decisions to all impacted platform and product teams.
• Coordinate with all impacted product teams to complete integration of requirement or justify no action and document it in Product Impact Assessment
• Maintain cross-functional, platform and product alignment.
• Present summary of details and advice to Product External Requirement governance for a decision on Amgen’s position regarding a standard’s impact.

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 Science or Engineering and previous experience in a medical device industry - 5 years current medical device industry experience .
- Strong Expertise in ISO 10993 biocompatibility standard, especially parts 3,4,6,7,11, and 18
- Experience in drug/device combination product design and development - Familiar with with Medical Device Regulations (21CRF820 and ISO 13485).
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong Problem solving and communication skills.
- Must be capable of working on multiple projects in a deadline driven environment.

Red Flags:
Not employed for more than 6 months.

Interview Process:
Phone / Webex 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, Medical Combination Devices (JP11898) - Thousand Oaks, CA

Fri, 13 Oct 2023 18:26:54 GMT

Job Title: Engineer, Medical Combination Devices (JP11898)
Location: Thousand Oaks, CA. 91320
Business Unit: Combination Product Development
Employment Type: Contract
Duration: 1+ years (with possible extensions)
Rate: $38 - $42/hour W2
Posting Date: 10/31/2023
Notes: Only qualified candidates need apply. Local candidates only. Should be standard hours Monday to Friday
in Office to support Denmark 2 times a week may be expected to be on call at 6 am. can be done remote, but would come to site after call.

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

Job Description:
Note: Not interested in remote only candidates. Should be standard hours Monday to Friday in Office to support Denmark 2 times a week may be expected to be on call at 6 AM PST. Can be done remote, but would come to site after call. Time on campus will be lab work and will be working with lab equipment. There is hybrid opportunity once candidate is seen to be self-sufficient.

Ideal candidate, Familiarity with medical device engineering and applicable standards, preferably ISO 11608-1, and their application.

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 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.

Day to Day Responsibilities:

(50%) 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)
(30%) 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
(20%) Statistical data analysis of test results to be included in technical reports.

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

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

Red Flags:

Candidates with Software or Electrical engineering these are NOT desired for the role.
No lab experience.
Different industry (not exp of med device).
No mechanical or med device.
Spelling and grammatical errors in resume. Frequent short job durations and job hopping.

Interview Process:
Three to four one-on-one, 30 minute, remote interviews with various team members. Able to 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.

Senior Systems Engineer, Medical Device Technical Lead (JP11791) - Thousand Oaks, CA

Tue, 19 Sep 2023 15:35:22 GMT

Job Title: Senior Systems Engineer, Medical Device Technical Lead (JP11791)
Location: Thousand Oaks, CA.
Business Unit: Final Product Technical Leads
Employment Type: Contract
Duration: 18 Months with possible extensions or conversion to FTE
Rate: $46 - $51/hour W2
Posting Date: 09/19/2023

Notes: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered. Candidates must elaborate on their experience in Excel macros and product development on their resume.

3 Key Consulting is recruiting a Senior Systems Engineer, Medical Device Technical Lead for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description:

Candidates must have experience in the biotechnology, pharmaceutical, or medical device industry.
Candidates must have at least 5 years’ experience in systems engineering.
Candidates must have great communication skills and can lead meetings and work teams.
Candidates must have strong background in documenting requirements and providing traceability documentation for FDA approval
- DOORS
- Requisite Pro, or other similar requirements management software.
Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts experience is preferred.

The Systems Engineer (SE) works as part of cross-functional program teams to deliver technical content, performance, intellectual property and quality deliverables of a combination product development program.
The Systems Engineer understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems.
The Systems Engineer ensures that the quality targets are satisfied, identifies technical risks and assists risk retirement activities on the program.
The Systems Engineer 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.
Ability to communicate effectively and lead large teams in development of technical deliverables required for design control deliverables.
Past experience in writing SOPs, Guidance & technical documents is preferred but not required
Proficient in Microsoft Excel especially in writing macros in excel.

Day to Day 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 requirements documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Responsible for writing technical and guidance documents that provides guidance to team members in following design control and business processes within client.
Develop Toolsets using Microsoft excel 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.

Basic Qualifications:

BS in Engineering and 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.

Why is the Position Open?
Planned Project.

Red Flags:

No degree
No systems engineering experience

Interview Process:

Video Conference with Hiring Manager.
Selected candidates would then have a panel 1:1 video conference with additional team members.
Candidate must be comfortable with video (webcam) online interview process.

Senior Engineer, Biotech Combination Products (JP11782C) - Cambridge,
Wed, 13 Sep 2023 17:52:06 GMT
Job Title: Senior Engineer, Biotech Combination Products (JP11782C)
Location: Cambridge, MA. OR Thousand Oaks, CA.
Business Unit: Pre-filled Syringes and Lyo Kit Platforms
Employment Type: Contract
Duration: 18+ months (with possible extensions)
Rate: $45 - $51/hour W2
Posting Date: 09/13/2023
Notes: Only qualified candidates need apply. Onsite, with some WFH flexibility.

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

Job Description:
Ideal candidate: Minimum of 1 YOE project managing experience. 5-10 YOE in Engineering with background in med device, biotech, (Aero and Auto would also be considered). Bachelors or Masters Preferred. Preferred systems experience: Solid works, CAD, Smartsheet'

Lead and support the Prefilled syringe combination product platform team in both development and commercial lifecycle of prefilled syringe (PFS) configurations. Experience leading and managing project timelines and initiatives while reporting out to management. Scope includes a the full range of PFS devices and variants, such as; needle protection systems and different delivery volumes. The qualified candidate will lead technical teams to ensure successful device development of these mechanical devices. The Senior Engineer will work closely with team members acting as a project manager to develop detailed timelines for ensuring engineering specifications, device design & development, verification, validation, and regulatory submissions of these devices are completed on time.

Top Must Have Skill Sets:
Project Management
Technical understanding of design controls
Device Engineering experience

Day to Day Responsibilities:
Supporting platform and product development teams by acting as a project manager to ensure timelines and delivery dates are met. Providing technical support and insights to team members and leading platform initiative projects.

- Create and execute to project plans and schedules; responsible for ensuring team meets project timelines
- 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.
- Support development, execution, and review of 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:
- BS in Engineering and previous experience in a medical device industry
- 5-10 years current experience with engineering processes and procedures.
-Project Management experience
- Strong background in engineering and commercialization of 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
- Experience in drug/device combination product design and development
- Strong problem solving, risk assessment, and risk management skills
- Must be capable of working on multiple projects in a deadline driven environment.

Preferred Qualifications:

Why is the Position Open?
Supplement additional workload on team

Red Flags:
No Job hopping

Interview Process:
Initial Phone screenings and then Webex interviews with a panel of 3-6 team members.
Series of 1:1 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, Biotech Packaging - (JP11531) - Thousand Oaks, CA

Thu, 08 Jun 2023 16:38:02 GMT

Job Title: Associate Engineer, Biotech Packaging - (JP11531)
Location: Thousand Oaks, CA. 91320
Business Unit: Secondary Packaging
Employment Type: Contract
Duration: 2+ years with possibility of extensions and/or conversion to permament
Pay Rate: $30 - $35 per hour
Posting Date: 06/08/23
Notes: Only qualified candidates need to apply. This is not a remote position.

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

Job Description:
The successful candidate will be engaged and ready to work and learn. Will take risks and anticipate needs. Leans on team for direction when needed but is also independent. Provided consistent follow up. This is an entry level role, but should have some experience in Package engineering. Must have Bachelors in package engineering. Manager favors schools that specialize in package engineering.

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. Assists with project definition by performing engineering studies and assessment for automation system installations. Performs field evaluations of existing systems and provides engineering design recommendations.

Top Must Have Skill Sets:

AutoCad
CAPE
Dynamic lab testing equipment
Excellent communication, packaging fundamentals, proactivity.

Day to Day Responsibilities:
Support of Packaging development activities to include:

Writing of protocols and reports.
Testing builds and inspection
Communication with external testing labs
General engineering support

Basic Qualifications:

AutoCad
CAPE
Dynamic lab testing equipment
Excellent communication, packaging fundamentals, proactivity.

Why is the Position Open?
Backfill.

Red Flags:
Those without packaging work experience
without education in Packaging engineering

Interview Process:
1:1 Phone screens to begin then Webex
1:2-3 30min Webex 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, Carbon Emissions Accounting Strategy/Data Analyst - Thousand Oaks, CA

Thu, 01 Jun 2023 16:19:53 GMT

Job Title: Engineer Senior, Carbon Emissions Accounting/Data Analyst Strategy/Sustainability - Hybrid (JP11517)
Location: Thousand Oaks, CA. 91320
Business Unit: Environment and Sustainability
Employment Type: Contract to Hire
Duration: 6+ months (with possible extensions and conversion to permanent)
Rate: Minimum $50/hr W2 with no pay rate cap DOE.
Posting Date: 06/01/2023
Notes: Only qualified candidates need apply. Can be remote, but requires to be onsite at least two times during the engagement. Preferences to candidates in the greater Los Angeles area.

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

Job Description:
The successful candidate will reside in the greater LA area, and the expectation is that s/he would be required to be onsite 2x's min at our client’s Thousand Oaks, CA. area over the duration of 6 months. Manager’s education preference is Masters/PHD but would accept Bachelor’s with 4-6 YOE. It is preferred that the candidate has certifications in Sustain Strategy or other certification related to the environmental sustainability field. Ability to perform a sensitivity analysis for various carbon accounting methods and work with databases such as EcoInvent and GaBi.

Data analyst position (6-months) within the Global Operations Environmental Sustainability Team, housed in Engineering and working directly with our Scope 3 carbon strategy lead. In 2022, our client set science-based targets with the Science Based Target Initiative to decarbonize their operations and value chain (Scope 3). The role will support the expansion of Scope 3 carbon accounting methodology from a global to a local level to assess additional opportunities across our business units, functions, and our suppliers.

Candidate must be a critical thinker who can constructively challenge conventional ways of thinking and introduce new ideas in data analysis and carbon accounting.

Roles and Responsibilities include:

Directly working with our Scope 3 carbon strategy manager to expand methodology from a global to local level.
Perform a sensitivity analysis for various carbon accounting methods and work with databases such as EcoInvent and GaBi.
Collaborate with the company’s internal functions to advance a Scope 3 methodology.
The role can be remote but preference over Los Angeles, CA, to work on-site at client’s Thousand Oaks, CA, location.

Top Must Have Skill Sets:

Data analysis skills
Knowledge of key sustainability initiatives such as the Greenhouse Gas Protocol, Science Based Targets, as well as greenhouse gas inventories and databases.

Day to Day Responsibilities:

Directly working with our Scope 3 carbon strategy manager to expand methodology from a global to local level.
Perform a sensitivity analysis for various carbon accounting methods and work with databases such as EcoInvent and GaBi.
Collaborate with the company’s internal functions to advance a Scope 3 methodology.

Basic Qualifications:

Data analysis skills
Strong teamwork and interpersonal skills
Ability to interact in a professional manner with cross-functional managers
Knowledge of key sustainability initiatives such as the Greenhouse Gas Protocol, Science Based Targets, as well as greenhouse gas inventories and databases.

Why is the Position Open?
Planned Project.

Employee Value Proposition:

Potential to convert to Full time employment at our client.
Unique and exciting opportunity to decarbonize the scope. Assist in pulling large data sets and analyze by business unit to support launch of strategies around the world.

Interview Process:

Manager will phone screen potential candidates 1:1 (30min call)
Select candidates would move to a 2nd interview 1:3 interview.
Candidates should be prepared to discuss and walk through allocate emissions in different scopes and challenges in Carbon Accounting.

Engineer, Combination Product Design and Characterization (JP11469) - Cambridge, MA

Mon, 22 May 2023 12:30:44 GMT

Job Title: Engineer, Combination Product Design and Characterization (JP11469)
Location: Cambridge, MA. 02138
Business Unit: Device Strategy Technology Assessment
Employment Type: Contract
Duration: 12 months (with likely extensions and/or conversion to permanent!)
Rate: $37 - $43/hour W2
Posting Date: 5/17/23
Notes: Only qualified candidates need apply. 100% onsite.

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.

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 optimally across different functions to successfully complete projects.
This role will be required to:

Become comfortable with thinking creatively and being self-motivated to further add value to the organization.
Assist with project definition by performing engineering studies/assessments for drug delivery systems for characterization or qualification in a GMP environment.
Work in a laboratory environment daily, performing experiments and operating laboratory equipment, including 3D printers, tensile testers, and viscosity testers
Author and execute protocols and technical reports summarizing key findings and results.
Perform evaluations of existing systems and provide engineering design recommendations.
Provide detailed data analysis and recommendations to enable senior staff to make informed decisions.

Top Must Have Skill Sets:

Self-motivated
Fast and continuous learner
Flexible/highly adaptive to continuous changing priorities/environment

Day to Day Responsibilities:

Become comfortable with thinking creatively and being self-motivated to further add value to the organization.
Assist with project definition by performing engineering studies/assessments for drug delivery systems for characterization or qualification in a GMP environment.
Work in a laboratory environment daily, performing experiments and operating laboratory equipment, including 3D printers, tensile testers, and viscosity testers
Author and execute protocols and technical reports summarizing key findings and results.
Perform evaluations of existing systems and provide engineering design recommendations.
Provide detailed data analysis and recommendations to enable senior staff to make informed decisions.

Basic Qualifications:

B.S. in Engineering
Effective Communicator (Oral/Written)
Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

Preferred Qualifications:

Relevant experience (pharmaceutical industry, combination products, medical devices, etc.)
Lab/testing experience
Data analysis (software: e.g. JMP, Minitab)
Project management / multi-tasker to enable handling multiple deliverables/priorities
Design Controls / Combination Products
Regulatory Standards
Problem Solving / Root Cause Analysis
Strong individual contributor
Collaborative team player
Fast and continuous learner
Flexible/highly adaptive to continuous changing priorities/environment

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

Red Flags:

Seeking Remote Work
Not comfortable with lab equipment

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.

Appeals and Grievances Lead - (LA18808) - Los Angeles, CA

Tue, 18 Apr 2023 12:10:52 GMT

Job Title: Appeals and Grievances Lead - (LA18808)
Location: Los Angeles, CA. 90017
Business Unit: A&G
Employment Type: Contract
Duration: 2+ years with likely Extensions or Conversion to Permanent.
Pay Rate: $32.30 - $41.80 per hour/W2
Posting Date: 4/18/23
Notes: Only qualified candidates need apply. Hybrid: Onsite as needed.

3 Key Consulting is recruiting an Appeals and Grievances Lead for a consulting engagement with our direct client, a leading government-funded managed care health plan.

Job Description:
The Lead of Customer Solution Center Appeals and Grievances is responsible for assisting with the development of a successful and cohesive Appeals and Grievance unit, with a high level of productivity to achieve the department's overall performance metrics, and to meet and/or exceed member satisfaction. Responsible for the day-to-day oversight of Appeals and Grievance Specialist by closely monitoring work, providing feedback on performance, trains, coaching, mentoring, motivating, and ensures compliance to policies, procedures and regulations. Ensures that all Appeals and Grievances are processed accurately and timely.

Top Must Have Skill Sets:

At least 4 years of managed care appeals and grievance experience.
At least 1 year as a lead/supervisor

Day to Day Responsibilities:
Leads day to day activities of the Appeals and Grievances team including but not limited to:

Providing direction to the team, handling internal or external questions or issues raised in relation to Appeals or Grievances and recommending and implementing resolution, new processes and or process improvement.
Assist Supervisor to ensure that Specialist provide accurate, timely, and quality responses.
Ensure that all departmental policies, procedures and standards are being followed in an effort to meet departmental and organizational goals.
Assist the Supervisors to ensure that deviations in performance are identified in advance and process changes are made to redirect performance to acceptable levels.
Provides accurate and timely written and/or verbal statistical reports that includes historical and/or current data to aid in projecting or evaluating Compliance status.
Assist Supervisor in reviewing the Specialists overall quality and accuracy, provide education and training where applicable to remediate reoccurrences.
Support and lead the distribution and redistribution of inventory and/or assignments as needed.
Ability to accurately process all case types including regulatory cases and to provide recommendations towards resolution.
Trains and motivates staff.
Ensures appropriate compliance standards are followed and maintained.
Work closely with Supervisors to create and/or modify Desk Level Procedures.
Work closely with management to review performance and quality standards on an ongoing basis.
As well as motivational programs needed to achieve regulatory standards.
Acts as a back-up to the Supervisor leading meetings and handling escalations as required.
Performs other duties as assigned.

Basic Qualifications:

Associate's Degree. In lieu of degree, equivalent education and/or experience may be considered.
At least 4 years of Appeals and Grievance experience and experience working with firm deadlines, able to interpret and apply regulations.
At least 1-2 years of lead experience.
Must have strong knowledge of CMS, DMHC, and DHCS regulations. Must know Medical Terminology.
Must have excellent written and verbal communication skills.
Possess skillset to effectively communicate with all levels including but not limited to members, peers, leaders, physicians, executives, and regulatory entities.
Strong analytical, coaching/mentoring skills, team building.
Ability to work effectively with diverse team members.
Must also have the ability to troubleshoot problem areas and recommend effective alternative solutions to handle irate members, and provide optimal customer service for internal and external customers.
Must be flexible with time and be able to work weekends.
Must be able to multitask and to streamline day to day operations, policies and procedures.
Must have advance PC skills including Word, Excel and Access.
Must be organized, detail oriented, able to exercise strong independent judgment; poses conflict resolution and persuasion skills.

Preferred Qualifications:

Bachelor’s degree.
Experience in working with the disadvantage population, Medi-Cal, Covered California, and Cal MediConnect.
One year lead experience in a health plan/healthcare.

Engineer, Biomedical/Medical Device - (JP11347) - Thousand Oaks, CA

Mon, 13 Mar 2023 17:56:29 GMT

Job Title: Engineer, Biomedical/Medical Device - (JP11347)
Location: Thousand Oaks, CA. 91320
Business Unit: Systems Engineering
Employment Type: 1 year contract to hire.
Posting Date: 03/13/2023
Notes: Only qualified candidates need apply. Job requires on-site attendance. Shift/Schedule: Monday - Friday, 8am - 5pm (ATO).

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

Top Must Have Skill Sets:

Hands on Laboratory Experience in a GLP Setting- 1+ years of experience.
Good Communication and Technical Writing Skills
Ability to Multitask
Must have BS degree Mechanical or Biomedical Engineering, or related field.

Day to Day Responsibilities:

Test procedure development and functional test execution
Authoring technical plans and reports
Performing statistical data analysis
Supporting technical assessments and root cause investigations
Transfer of information to manufacturing sites, engagement with suppliers
Maintenance of Design History File content consistent with Good Documentation Practices

Basic Qualifications:

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

Red Flags:

No laboratory experience or desire to work in a lab environment (not considering less than a year)
No desire to work in cross-functional team environment
Poor communication and technical writing skills
Many positions in a short time frame (e.g. 3 per year)
Interested in remote-only; this job requires on-site attendance

Mechanical Engineer III - (TYR0231024) - Saint Joseph, MO

Wed, 15 Feb 2023 19:05:11 GMT

Job Title: Mechanical Engineer III - (TYR0231024)
Location: Saint Joseph, MO. 64501
Employment Type: Permanent. Nationwide Relocation Available
Posting Date: 02/08/2023
Notes: Only qualified candidates need apply.

3 Key Consulting is recruiting a Mechanical Engineer III for a consulting engagement with our direct client, a leading Food Processing Company

Job Description:
This position will be a member of the Manufacturing Services Team supporting the Manufacturing Solution business processes for all of company. The position works within a team environment as a business partner and liaison to the IS organization to implement enterprise solutions to existing manufacturing processes and identify opportunities for process improvement and systems integration.

Top Must Have Skill Sets:

Bachelor's in Mechanical Engineering.
5+ years experience. AutoCAD experience.

Day to Day Responsibilities:

Provides technical guidance and decision making for the engineering staff on design problems to maintain optimum utilization of time, money, and materials.
Informs appropriate employees of schedule changes, changes in project specifications and labor variances; coordinates their activities so that appropriate changes are enacted thereby meeting engineering goals.
Resolves staff needs and questions as well as helps to resolve employee complaints and problems to maintain a harmonious work environment.
Performs responsibilities as Project Engineer on an as-needed basis.
Makes drawings, designs systems, contacts vendors and supervises the installation and construction process to ensure that the engineering aspect of project is fully met.
Attends meetings with Operations, Marketing and R&D personnel to provide technical assistance on development of product lines. Advises the group of the engineering feasibility, cost, time, etc. involved in undertaking projects under consideration.
Meets with the engineering staff weekly to discuss progress on projects and takes direct action when needed to prevent or resolve any delays. Relays information regarding the following weeks engineering schedule to Maintenance Superintendent for his use in preparing the maintenance schedule.
Schedules engineering projects according to time and talents of staff. Updates the engineering project list as needed. Meets with the Engineering staff and appropriate management committee personnel to provide information and assign priorities.
Maintains an appropriate level of knowledge in engineering to maintain an aggressive engineering area. Attends technical schools and seminars and reads available material to remain up to date on engineering advances. Visits with vendors and other facilities to inspect equipment which might have an application at our facility.
Take appropriate action to ensure the integrity of the SQF System. Report any issues to appropriate facility management.

Basic Qualifications:
Education: Bachelor's Degree in Mechanical Engineering
Experience: Five years' experience in engineering staff management and project management is preferred. In addition, exposure to food plant design and food science basics preferred. AutoCAD experience required.
Must submit a resume in .pdf or Word format to be considered.

Preferred Qualifications:
7+ years experience

Employee Value Proposition:
Career development and ability to grow. Annual incentive plan. Full benefits. National relocation available.

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.

Lead Electrical Engineer - (BS 2023_04077) - Nashville, TN

Fri, 03 Feb 2023 13:44:36 GMT

Job Title: Lead Electrical Engineer - (BS 2023_04077)
Location: Nashville, TN
Employment Type: Permanent
Posting Date: 02/03/2023
Notes: Only qualified candidates need apply. Must have BSEE degree.

3 Key Consulting is recruiting a Lead Electrical Engineer for our direct client, a leading global automotive manufacturing and services company.

Job Description:
We are seeking an Electrical Engineer (EE). The Electrical Engineering position researches, develops, designs, and tests electrical components, equipment, systems, and networks. The Lead Electrical Engineer will be a part of our client’s Corporate Engineering function, otherwise known as Process Systems Development (PSD). A Lead Professional position is a recognized subject matter expert in a job area typically obtained through advanced education and work experience. Problems faced are difficult and often complex. Requires periodic communication and interaction with leadership. The ideal candidate will be located in Nashville, TN. However, the client is open to the right individual working remotely within a 1 hour drive of their Aiken, SC plant or their Wilson, NC plant. Travel requirements are project dependent and vary from 40-65%

You will Lead large projects or processes of complex scope, with limited oversight from manager.
Travel requirements are project dependent and vary from 40-65%
You will Coach, review and delegate work to lower level professionals.
You will Assist in the development of operational plan and implements for areas of assigned responsibilities.
You will Identify continuous improvement/automation activities.
You will Design and install/implement electrical equipment, facilities, components, products, and systems for commercial and industrial purposes.

Supports relationships through strong communication and negotiation skills with internal and external stakeholders.
Significant Experience in Ladder Logic, Safety PLC programming, and HMI design.

Experience in Allen Bradley software Studio/RS Logix 5000, FactoryTalk View Studio, and RSLinx Classic/OEM.
Supports continuous improvement/automation activities.

Determines method of research for the planning, design development and testing of electrical equipment, facilities, components, products, and systems for commercial, industrial, and domestic purposes.

Top Must-Have Skill Sets:

Supports relationships through strong communication and negotiation skills with internal and external stakeholders.
Significant Experience in Ladder Logic, Safety PLC programming, and HMI design.
Experience in Allen Bradley software Studio/RS Logix 5000, FactoryTalk View Studio, and RSLinx Classic/OEM.
MUST HAVE A BSEE DEGREE

Preferred Qualifications:
Experience in Manufacturing or the Automotive Industry is a plus also Project Management experience.

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, Biotech Process Engineering (JP10544) - Thousand Oaks, ca

Tue, 12 Jul 2022 14:23:23 GMT

Job Title: Engineer, Biotech Process Engineering (JP10544)
Location: Thousand Oaks, CA 91320, (Hybrid, 2-3 days/week onsite)
Employment Type: Contract to Hire
Duration: 12 months with likely extensions or conversion to permanent
Job posting date: 7/12/2022
Note: Hybrid position. Candidate will be required to be on site half the week and may work remotely 1-2 days a week. Must have biotech background/experience, plus must have purification experience.

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

Job Summary:

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 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 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 collaborates with other functions such as Manufacturing, Quality, and Regulatory

BASIC QUALIFICATIONS:
Master’s degree OR
Bachelor’s degree OR
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 scale-up principles and commercial cGMP manufacturing facilities
Background in biologics tech transfer into commercial facilities
Purification process knowledge:
- Knowledge of purification processes/ equipment; scale up factors from, chromatography, UF/DF, 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 Skill Sets:

Must have biotech background/experience, plus must have purification experience.
Strong understanding of data analysis tools.
Knowledge of biologics purification processes/ equipment; scale up factors from, chromatography
1+ years of Process Engineering experience preferably related to scale-up principles and commercial cGMP manufacturing facilities
Manufacturing experience must be biotech experience

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

Red Flags:

Multiple short duration jobs on resume
No purification experience - critical experience (Chromatography, purification, USTF)
Manufacturing experience - must be biotech experience

Interview Process:
Phone screen followed by Webex interview

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 look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

Engineer, Biopharma Medical Device (JP10473) - Thousand Oaks, CA

Thu, 23 Jun 2022 13:45:59 GMT

Job Title: Engineer, Biopharma Medical Device (JP10473)
Location: Thousand Oaks, CA. (Hybrid, 50% onsite/remote)
Employment Type: Contract
Business Unit: PFS And Lyo Kit Platforms
Duration: 1year with likely extensions or conversion to perm
Posting Date: 06/23/2022

3 Key Consulting is hiring an Engineer, Medical Drug Delivery Device 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 related design center activities for commercialized drug delivery devices. This includes technical operations support for contract manufacturing, failure investigation, leading and assessing design changes, develop test procedures, scale-up and global launch, supplier development, and continues improvement.
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 and electro-mechanical delivery devices are maintained. The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.

Essential skills and Responsibilities:

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.
Accountability of maintaining technical records within design history file associated with assigned products
Develop Test Method, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
Lead system level root cause investigation, coordinate design improvements with development partners, strategic planning and execution of design changes and improvements.
Works with Scientists and Engineers internally and externally 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 regulation:=
Quality System Regulation – 21CFR820
Risk Management – ISO 14971
EU Medical Device requirements – Council Directive 93/42/EEC

Basic Qualifications:
BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3+ years of experience within the pharmaceutical/biotechnology industry.

Preferred Qualifications:

Degree in the field of Mechanical or Biomedical
Medical device industry experience and regulated work environment experience
Background in developing and commercialization of medical devices and knowledge of manufacturing processes
Strong understanding and experience in design controls, failure investigation, initiating and bringing complex projects to conclusion and the ability to work independently and dynamic cross functional teams
Excellent written and verbal communication skill

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

Top Must-Have Skill Sets:

Must have hands on Laboratory experience in a GLP Setting (Science or Engineering Lab)
BS Degree in the field of Mechanical, Chemistry, Biomedical, Engineering, or any science degree
Seeking a candidate with regulated work environment experience

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.

Red Flags:
1. No laboratory experience or desire to work in a lab environment
3. No desire to work in cross-functional team environment
4. No technical writing skills
5. No BS degree

Employee Value Proposition:
To work for a dynamic team

Interview process:
Webex with HM
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 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.

Specialist I.S. Analyst - (JP10379) - Cambridge, MA

Mon, 06 Jun 2022 14:24:22 GMT

Job Title: Specialist I.S. Analyst - (JP10379)
Location: Cambridge, MA. 02138
Employment Type: Contract
Business Unit: Attribute Sciences Data Engineering
Duration: 1+ years (with likely extensions)
Notes: Only qualified candidates, please.

Posting Date: 06/06/22

3 Key Consulting is hiring a Specialist I.S. Analyst for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Attribute Sciences Data Engineering (ASDE) group provides scientific and technical engineering expertise in support of Amgen’s pipeline and commercial portfolio. This team applies advanced data & computational analytics to advance products across all stages of therapeutic development.
This position is part of the ASDE group and will support the product and method monitoring for Amgen’s late stage and commercial portfolio. Responsibilities will vary and include identification of abnormal data trend, ad-hoc statistical analysis, support for document generation, and collaborating cross-functionally to implement corrections. Another responsibility of this role will be the identification and development of optimization opportunities in existing tools, processes, and procedures. The position offers the opportunity to engage with data from multiple product modalities and a variety of groups and functions across Amgen’s global manufacturing and quality networks.
Position Responsibilities:

Interface with data engineers, system architects, and system owners to understand our data systems to enable the extraction, transformation, and loading of key data into new systems
Maintenance of existing systems and data pipelines
Apply statistical trending tools, such as statistical process control and multivariate analysis, to product and method data to understand sources of variation and evaluate opportunities for improvements
Support on-going GMP activities such as the generation of the annual product review documents, regulatory inspections, and process documentation
Interface with analytical scientists, process development scientists, and engineers to assess, understand, and support data consumption needs

Basic Qualifications:

Master’s degree

Bachelor’s degree and 2 years of scientific or engineering experience

Associate’s degree and 6 years of scientific or engineering experience

High school diploma / GED and 8 years of scientific or engineering experience

Preferred Qualifications:

Experience with programming languages (i.e. Python, R, and SQL) and programming concepts (i.e. data types, data structures, objects etc.)
Familiarity with statistics concepts (i.e. distributions, regression techniques, classification)
Experience with business intelligence and analysis tools (i.e. Spotfire/R-Shiny/JMP) to aggregate, analyze, and visualize data
Experience in generating easy to use dashboards to rapidly and dynamically visualize data
Ability to deliver high quality results in a timely manner
Excellent written and verbal communication
Demonstrated ability to work under minimal direction
Ability to adapt to changing business needs
Ability to multi-task and function in a dynamic environment
Ability to solve difficult, non-routine analysis problems, applying advanced statistical analysis as needed

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

Top Must-Have Skill Sets:

MUST have SQL experience
MUST have Python, R, or similar programming language experience
Experience in presenting data to upper management

Day to Day Responsibilities:

Interface with data engineers, system architects, and system owners to understand our data systems to enable the extraction, transformation, and loading of key data into new systems
Maintenance of existing systems and data pipelines
Apply statistical trending tools, such as statistical process control and multivariate analysis, to product and method data to understand sources of variation and evaluate opportunities for improvements
Support on-going GMP activities such as the generation of the annual product review documents, regulatory inspections, and process documentation
Interface with analytical scientists, process development scientists, and engineers to assess, understand, and support data consumption needs

Employee Value Proposition:

Red Flags:

Very frequent job changes
See top must have skill sets

Interview process:
Phone screening 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.

MCS Associate Quality Control, Biopharma (JP10321) - Thousand Oaks, CA

Wed, 25 May 2022 15:08:16 GMT

Job Title: MCS Associate Quality Control, Biopharma (JP10321)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: ATO Quality Control
Duration: 18 months with likely extensions to conversion to FTE
Rate: 22 - 26/hour W2.
Posting Date: 05/25/2022

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

Job Description:
Under general supervision, this position will perform routine procedures and testing in support of the lab. This position will be responsible for one or more of the following activities:

Performing routine laboratory procedures
Routine analytical testing - Documenting, computing, compiling, interpreting, and entering data
Maintaining and operating specialized equipment
Initiating and / or implementing changes in controlled documents.

Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.

Basic Qualifications:
Bachelor’s degree and 2 years of Quality Control, Quality Assurance or related experience
OR Associate’s degree and 6 years of Quality Control, Quality Assurance or related experience
OR High school diploma / GED and 8 years of Quality Control, Quality Assurance or related experience

Preferred Qualifications:

Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to organize work, handle multiple priorities and meet deadlines
Strong written and oral communication skills
Must be detail orientated
Must be flexible and adaptable to changing priorities and requirements
Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
Demonstrates understanding of when and how to appropriately escalate.
May identify, recommend and implement improvements related to routine job functions.
Must learn and comply with safety guideline and cGMPs.

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

Top Must-Have Skill Sets:

Pipetting
Documentation
Attention to Detail
Quality Control, Quality Assurance or related experience - 2+ years
Biology degree is ideal - science field (chemistry, biochem, biology)
Lab experience is a must

Day to Day Responsibilities:
Testing:

Execute routine and non-routine testing procedures and assays
Perform data analysis of testing results and communicate results to appropriate sources
Comply with safety guidelines
Learn and comply with GLP, and cGMPs, which includes, but are not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory logbooks.
Material/Data Management
Responsible for documenting, computing, compiling, interpreting, and entering data
Responsible for the inventory management of all media, and reagents
Ensure the timely disposal of tested samples

Employee Value Proposition:
The person in this role will work with 22 different molecules. You will be very hands on and see medicines go to patients. This position has great opportunities for growth.

Red Flags:
No experience outside of course work
Entry level position

Interview process:
Phone screening followed by in-person interview.

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 https://3kc.catsone.com/careers/2010-General You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

Project Manager Senior, Biopharma GMP Tech Transfer (JP10191) - Holly Springs, NC

Fri, 06 May 2022 02:15:55 GMT

Job Title: Project Manager Senior, Biopharma GMP Tech Transfer (JP10191)
Location: Holly Springs, NC. 27450
Employment Type: Contract
Business Unit: CIDA Design and Innovation
Duration: 1+ years (with likely extensions)
Notes: Hybrid (remote and onsite). Work can be performed primarily remotely. Some travel may be required per project needs
Posting Date: 05/06/2022

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

Job Description:

Manages one or more complex tactical/strategic projects during the startup of a Drug Substance operation.
Responsible for project delivery within scope, quality, time, and cost parameters. Responsibilities may include management of all phases of the projects life cycle.
Lead requirements/scope definition, team formation and resources planning, schedule development, identification of risks and development of the change management and communications plan.
The PM will also oversee project execution through closure; managing schedule, resources, budget, risks, stakeholders, and communication at multiple levels of the organization.
Coordinates and directs the activities of project team members.
Ensures all project requirements and/or objectives are documented.
Regularly interacts with management. May be responsible for cross-functional teams.

Why is the Position Open?
Team need.

Top Must-Have Skill Sets:
1. Expertise running medium to large scale projects for GMP Tech Transfer / Operational Readiness
2. Biopharmaceutical Drug Substance manufacturing experience/understanding
3. Strong analytical and communication skills across organizational levels (workstream – senior management)
4. Strong MS Project, MS PowerPoint and MS Excel skills
5. Tactical and Strategic thinking

***Smartsheet and MS teams a plus
***PMP a plus

Day to Day Responsibilities:

Lead overall Operational Readiness planning and execution during site start up
Cross-functional integration of workstreams
Maintain tasks, action items, risk registry, minutes and KPI metrics
Collaborate a long a wide variety of Leads and Project Managers for Construction, Tech Transfer, Process Equipment, Talent Strategy, Commissioning, and Digital Manufacturing
Provide project updates on a regular basis at multiple project forums.
Expertise running medium to large scale projects within a matrix organization.
Excellent understanding of project management processes, methodologies and best practices.
Strong analytical skills.
Excellent communications skills across organization levels.
Ability to work effectively across multiple functions.
Strong MS Project, MS Word, Visio, MS PowerPoint and MS Excel skills.
Understanding of sharing and collaboration tools and systems (ie Smartsheets).

Employee Value Proposition:
The person in this role will have a unique opportunity to support and lead several aspects of the startup of a new Drug Substance manufacturing facility, impacting the whole operation, and collaborating with multiple workstreams throughout the project lifecycle (ie Construction, Commissioning, Tech Transfer, Quality, Supply Chain, etc). In the role, will also help client build our most advanced Drug Substance manufacturing facility, creating ~400 jobs in the coming years. This is a significant growth opportunity.

Red Flags:
Looking for an operations project manager *NOT* a construction industry worker

Interview process:
Phone screening followed by in-person 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.

MCS Associate Quality Control – (JP10109) - Thousand Oaks, CA

Fri, 22 Apr 2022 14:56:38 GMT

Job Title: MCS Associate Quality Control – (JP10109)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: ATO Quality Control
Duration: 1+ years (with likely extensions)
Notes:
Posting Date: 04/22/2022

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

Job Description:
Under general supervision, this position will perform routine procedures and testing in support of the lab. This position will be responsible for one or more of the following activities: - Performing routine laboratory procedures - Routine analytical testing - Documenting, computing, compiling, interpreting, and entering data - Maintaining and operating specialized equipment - Initiating and / or implementing changes in controlled documents. Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.

Basic Qualifications:
Bachelor’s degree and 2 years of Quality Control, Quality Assurance or related experience
OR
Associate’s degree and 6 years of Quality Control, Quality Assurance or related experience
OR
High school diploma / GED and 8 years of Quality Control, Quality Assurance or related experience

Preferred Qualifications:

Ability to adhere to regulatory requirements, written procedures and safety guidelines
Ability to evaluate documentation/data according to company and regulatory guidelines
Ability to organize work, handle multiple priorities and meet deadlines
Strong written and oral communication skills
Must be detail orientated
Must be flexible and adaptable to changing priorities and requirements
Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
Demonstrates understanding of when and how to appropriately escalate.
May identify, recommend and implement improvements related to routine job functions.
Must learn and comply with safety guideline and cGMPs.

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

Top Must-Have Skill Sets:

Pipetting
Aseptic
Documentation

Day to Day Responsibilities:
This Associate, in the Bioassay group, within client’s quality control organization will work in a dynamic team environment to support testing, and projects within the group. The successful candidate will be responsible for Bioassay lab activities including analytical testing and analysis, tracking and trending of data, lab cleaning, and equipment maintenance. Responsibilities:

Testing
- Execute routine and non-routine testing procedures and assays
- Perform data analysis of testing results and communicate results to appropriate sources
- Comply with safety guidelines
- Learn and comply with GLP, and cGMPs, which includes, but are not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory logbooks.
Material/Data Management
- Responsible for documenting, computing, compiling, interpreting, and entering data
- Responsible for the inventory management of all media, and reagents
- Ensure the timely disposal of tested samples.

Non-science degree
No lab experience

MCS Manufacturing Associate, Biopharma (JP9784) - Thousand Oaks, CA

Tue, 29 Mar 2022 10:32:35 GMT

Job Title: MCS Manufacturing Associate, Biopharma (JP9784)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Cell Culture
Duration: Initial 3 months with likely extensions
Posting Date: 3/29/2022
Notes: Onsite

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

Job Description:
The Associate of Manufacturing will work in a dynamic production environment at the client’s Thousand Oaks Site supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).

Responsibilities include:

Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
Preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
Performing and monitoring critical processes with the ability to perform basic troubleshooting
Performing in-process sampling of equipment and operating analytical equipment
Performing washroom activities: clean small and large scale equipment used in production activities
Maintaining an organized and clean workspace
Working in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work
Initiating quality reports
Drafting and revising documents (SOPs, MPs)
Identifying, recommending, and implementing improvements related to routine functions
Assisting in the review of documentation for assigned functions (equipment logs, batch records)
Performing activities that include periods of rigorous, repetitive work
Working around high-pressure systems and occasionally work around heavy equipment
Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule

Basic Qualifications:
Bachelor’s degree OR
Associate’s degree and 4 years of Manufacturing /Operations experience OR
High school diploma / GED and 6 years of Manufacturing /Operations experience
Able to work in teams to complete operational tasks
Able to take direction well, follow documents and policies at all times
Able to take initiative
Creates positive work environment through interactions with team members
Able to regularly lift up to 35lbs, push and pull objects that require up to 50lbs of force, and work on your feet for long durations
Able to perform the list of physical movements that may be necessary to perform daily functions on the production floor: bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to 6 feet off of the ground.

Preferred Qualifications:
Bachelor’s Degree in Biology and/or Life Sciences
Mechanically inclined

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

Top Must Have Skills:
1) Mechanical and technical ability
2) Must be able to work all shifts
3) Must be able to understand GMP and compliance
4) Must take initiative

Day to Day Responsibilities:
Working in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves to support the manufacture of drug substance using SOP's.

Employee Value Proposition:
Extension is highly likely - unique knowledge and experience

Red Flags:
Not local in distance to Amgen
No degree
If they are looking for research position, this is not it.
They need mechanical experience or show aptitude
Unable to work all shifts and be flexible (evenings, weekends, etc)

Interview process:
Phone and Webex.

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.

IS Analyst Senior Associate - Digital Workplace (JP9973) - Thousand Oaks, CA

Tue, 22 Mar 2022 16:26:44 GMT

Job Title: IS Analyst Senior Associate - Digital Workplace (JP9973)
Location: Thousand Oaks, Ca.
Employment Type: Contract
Business Unit: Digital Workplace Solutions
Duration: Initial 3 months with likely extensions
Job posting date: 3/22/2022
Note: Onsite 3 days per week Thousand Oaks

3 Key Consulting is hiring a Sr Associate IS Analyst for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
Member of IT team responsible for

Supporting the Deskside Services team in US / USTO (Thousand Oaks, Ca.) and work under supervision of US Deskside Service Staff to support USTO end user devices. Specific focus is required on device handling / IMAC (Install-Move-Add-Change) activities (such as onboarding new users / termination of users)
Guiding/monitoring (outsourced) activities to make sure new hires receive their devices in time when joining the client
Guiding/monitoring (outsourced) activities on device retrieval in case of terminations
Support US Deskside Service Staff on new upcoming M&A activities.
Supervise End User outsourced partner on device/asset activities such as handling new device deliveries, device quarantining, disposal and return to vendor activities.
Day to Day monitoring on (outsourced) deskside service performance on ticket/SLA compliance (incident, request and asset management.)
Support deskside projects and provide guidance and direction to (outsourced) deskside support staff where needed.

Basic Qualifications: Bachelors degree or Associates with 4-6 YOE with user desk side support

Top Must have Skill Sets:

Ability to work in a fast-paced, highly technical environment.
Excellent customer service skills with expertise in troubleshooting, diagnosing and solving complex problems
Experience delivering end user & desktop support services within regional or global companies required
Familiarity with supporting multiple device platforms – Windows, iOS, MacOS
Working knowledge of ITIL methodologies and systems
Experience successfully leading or delivery projects that impact an entire organization.

Employee Value Proposition:
The person in this role will support insourcing of client's patient contact center insourcing process. You will gain skills delivering user support and day to day management of services.

Red Flags:
1) No end user, deskside or technical support services background
2) Lack of strong interpersonal communication skills
Interview Process:
Phone screening 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 position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

Metrology Engineer - (JP9956) - Thousand Oaks, CA

Tue, 22 Mar 2022 13:55:37 GMT

Job Title: Metrology Engineer - (JP9956)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Engineering Business Operations
Duration: 1+ years (with likely extensions)
Notes: Onsite. Biotech/Pharma or Aerospace preferred.

Posting Date: 03/22/2022

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

Job Description:
This position is for a Metrology Engineer. Candidate must possess the ability to perform calibration and measurement systems with minimal supervision.

The successful candidate will have a demonstrated track record in the using Standard or Primary Instrument Standard in pharmaceutical metrology. Additionally, the candidate will possess the ability to interact with various departments/teams and other client sites to align/communicate the global calibration control program Specific experience with multiple measurement disciplines in areas such as flow, temperature and optics and light measurements in a Primary Metrology laboratory.

DUTIES AND RESPONSIBILITIES

1. Prepare calibration procedures/job plans and associated training materials.
2. Understanding of GMP regulations and Good Document Practices
3. Maintenance and calibration of instrument Standards

a. Electrical
b. Flow
c. Temperature
d. Optics

4. Understanding of measurement traceability
5. Working with Calibration Software
6. Programming skills with instruments using MATLAB, LabView Virtual instrument software architecture (VISA)
7. Good communication skills
8. Repair experience plus

Why is the Position Open?
Backfill.

Top Must-Have Skill Sets:

Calibration experience with primary standards
Computer skills
communication skills
Instrumentation experience
Instrumentation Programing experience

Day to Day Responsibilities:
Calibration of client instrument Standards (Flow, Electrical, Mass, Temperature), update SOP.

Basic Qualifications:

At least eight years’ experience in metrology engineering at a large company primary standards laboratory level or comparable related technical activities, including application of advanced measurement engineering principles and technology related to highly complex technical assignments.
Bachelor of Science degree or Master of Science degree in Electrical Engineering, Mechanical Engineering or Physics with a minimum of seven years engineering experience in pharmaceutical or electro-mechanical metrology (or other related fields).

Employee Value Proposition:
The person in this role will work for a major biotech company in their global standards lab. You will work with Primary instrument standards to support all if client's manufacturing sites.

Red Flags:

No calibration experience.
Many roles in a short period of time.
No instrumentation experience..
No college degree

Associate Quality Control – (JP9950) - West Greenwich, RI

Thu, 17 Mar 2022 12:15:11 GMT

Job Title: Associate Quality Control – (JP9950)
Location: West Greenwich, RI. 02817
Employment Type: Contract
Business Unit: ARI Quality Control
Duration: 2+ years (with likely extensions
Notes: General lab experience/lab background, GDP/GMP experience, ability to work in teams. 100% onsite - Essential CW. Shifts: There are two shifts: Saturday – Tuesday 7AM to 5PM or Tuesday – Friday 7AM to 5PM shift schedule. In the screening process the manager will speak with them about the shifts that are available.
Posting Date: 03/17/22

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

Job Description:
Under minimal supervision, this position will be responsible for activities including microbiology & analytical testing, sample and data management and equipment and instrumentation operation and maintenance in a highly dynamic, team environment. This position will be responsible for one or more of the following activities:

Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring.
Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures.
Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks.
Operate and maintain specialized laboratory equipment and instrumentation.
Participate in laboratory investigations and audits as necessary.
Perform general laboratory housekeeping activities.
Maintain training compliance and proficiency.
At all times, comply with safety guidelines, cGMPs/CFRs and other applicable regulatory requirements.
Shift: Needs to be open for either a Saturday – Tuesday and/or a Tuesday – Friday shift schedule.

Top Must-Have Skill Sets:

Experience with environmental monitoring a huge plus
Experience with aseptic techniques / sterilizing/ biotech manufacturing highly preferred
Lab experience, science background, sample handling experience

Day to Day Responsibilities:
Performing water, environmental, and gas sample collection from the clean room manufacturing areas. Incubating and testing environmental samples collected from manufacturing and Quality Control areas, and being able to work within automated sampling systems such as LIMS, LMES, and CIMS.

Preferred Qualifications:
Some previous lab experience is preferred.

Employee Value Proposition:
Career growth/ opportunity

Red Flags:

Multiple positions within the course of a year or if a staff member only wants to work from home or as an individual contributor - as this is an onsite (USRI) essential position requiring staff to work within a team.
PhD is very likely overqualified

Associate- HPLC Chromatography (JP9847) - Thousand Oaks, CA

Mon, 21 Feb 2022 14:16:57 GMT

Job Title: Associate- HPLC Chromatography (JP9847)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months. Possible extension for an additional 1-2 years
Job posting date: 2/21/2022
Note: Onsite Essential

3 Key Consulting is hiring a Associate- HPLC Chromatography for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Ideal Candidate-

1+ year of industry (ideally) or academia in a lab setting with Pipetting,
Sample prep & handling,
HPLC Chromatography,
Protein sample analysis (ideal).
BS degree in pharmaceutics, biochemistry, chemistry, or related life sciences discipline.
A strong understanding of protein biochemistry and protein structure, as well as significant experience with basic laboratory skills and biophysical techniques related to protein analysis is essential.
A background in protein solution manipulation (e.g., pipetting, dialysis, concentration) and HPLC analysis is expected.
Experience with visible and sub-visible particle analysis and other analytical methods is desirable.

Job description
We are currently seeking a research associate for the Drug Product Technologies group in Thousand Oaks, CA.
A fundamental understanding of protein chemistry, formulation, and biophysical characterization is desired.
The successful candidate will perform experiments related to the development of formulations for therapeutic proteins, including stability testing and analytical characterization.
The candidate will join a team of investigators using a variety of biochemical and biophysical techniques and will be involved in the design and execution of experiments.
A background in protein solution manipulation (e.g., pipetting, dialysis, concentration) and HPLC analysis is expected.
Experience with visible and sub-visible particle analysis and other analytical methods is desirable
Responsibilities will include detailed record keeping in electronic laboratory notebooks, analysis, and interpretation of experimental data.

Basic qualifications
BS degree in pharmaceutics, biochemistry, chemistry, or related life sciences discipline.
A strong understanding of protein biochemistry and protein structure, as well as significant experience with basic laboratory skills and biophysical techniques related to protein analysis is essential.
The applicants must be motivated, have good problem-solving skills, and an aptitude to learn and implement new techniques/skills.
The candidate should be well organized and proficient in detailed record-keeping, have excellent written and oral communication skills, and be capable of working efficiently in teams and independently.

Top Must have Skill Sets:

HPLC
Pipetting
Protein sample analysis

Day-To-Day Responsibilities:

The successful candidate will perform experiments related to the development of formulations for therapeutic proteins, including stability testing and analytical characterization.
The candidate will join a team of investigators using a variety of biochemical and biophysical techniques and will be involved in the design and execution of experiments.

Employee Value Proposition:
The chance to gain valuable hands-on work experience from an industry leader, as well as a possible extension.

Red Flags:
No experience in hplc/chromatography

Interview Process:
Phone Screen
Final Round -Onsite/Virtual interview.

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 look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

Lab Manager (JP9779) - Thousand Oaks, ca

Tue, 08 Feb 2022 14:30:32 GMT

Job Title: Lab Manager (JP9779)
Location: Thousand Oaks, CA
Employment Type: Contract
Business Unit: Drug Product & Process Development
Duration: 3 years
Job posting date: 2/8/2022
Rate: $30-33/HR
Note: Onsite Essential

3 Key Consulting is hiring a Lab Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
Come join a dynamic team of laboratory managers for Drug Product Technologies. You will have ownership of a suite of laboratories. Included in this ownership you will be responsible for daily upkeep, scheduling and oversight of instrument maintenance, coordinating schedules with client’s scientists, as well as many other tasks related to keeping our laboratory space in top working order. A fast paced, engaging job where you will have the opportunity to interact daily with our fantastic team.

Top Must have Skill Sets:

Previous experience as an individual contributor on a project or program - self motivated
Strong indication of highly organized individual
Experienced using the Microsoft office suite of programs (excel, PowerPoint, word, etc...)

Day-To-Day Responsibilities:

Oversee the upkeep of all development lab space to appropriate standards for effective scientific use.
Build relationships with strategic partners to deliver improved instrument maintenance and oversight.
Foster dynamic relationships with scientists to better serve their needs in the lab.
Project manage various business or operations related initiatives.

Employee Value Proposition:
Career growth experience.

Red Flags:

Must be able to come on campus in Thousand Oaks daily
Not self-motivated
Limited experience w/ contributing to a team/ project.

Interview Process:
1:1 virtual interview for 30 minutes with the 4 managers. Must be available to start interviewing immediately. (The candidate will have 4 1:1 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 look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

Senior Associate Quality Control - (JP9706) - Thousand Oaks, CA

Fri, 04 Feb 2022 15:59:35 GMT

Job Title: Senior Associate Quality Control - (JP9706)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Clinical Process and Chemical Analysis
Duration: 18+ months (with likely extensions)
Notes: Onsite
Posting Date: 2/4/2022

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

Job Description:
This Associate, in the Bioassay group, within client’s quality control organization will work in a dynamic team environment to support testing, and projects within the group. The successful candidate will be responsible for Bioassay lab activities including analytical testing and analysis, tracking and trending of data, lab cleaning, and equipment maintenance.

Why is the Position Open?
Backfill, and additional workload.

Top Must-Have Skill Sets:

Pipetting
Aseptic technique
Cell culture
Degree: Biology Degree (Bachelors), will consider new grad

Day to Day Responsibilities:

Sample potency testing using qualified cell or antigen/receptor based methodology
Testing
- Execute routine and non-routine testing procedures and assays
- Perform data analysis of testing results and communicate results to appropriate sources
- Comply with safety guidelines
- Learn and comply with GLP, and cGMPs, which includes, but are not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory logbooks.
Material/Data Management
- Responsible for documenting, computing, compiling, interpreting, and entering data
- Responsible for the inventory management of all media, and reagents
- Ensure the timely disposal of tested samples.

Red Flags:

HPLC
Gels

Sr Associate Scientist (JP9705) - Thousand Oaks, CA

Mon, 24 Jan 2022 16:55:24 GMT

Job Title: Sr Associate Scientist (JP9705)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 1/24/2022
Note: Onsite Essential

3 Key Consulting is hiring a Sr Associate Scientist for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:

Bachelors' degree & 3 YOE
To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.

Responsibilities include:
Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision.
Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data.
Effectively transfers experimental methods from literature to the lab and makes modifications as necessary.
Develops and implements new protocols with moderate review.
Engages coworkers in scientific discussions.
Communicates data and interpretation to work group.
Skilled at developing systems to ensure quality data.
Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques.
Effectively trouble-shoots equipment and experimental difficulties
Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents
Participates in department-wide support efforts such as safety, recruiting and committees
May train staff and/or supervise others
Coordinates and organizes resources needed to complete the task? Understands when to seek input and when to make independent judgments;

Skills:
Degree in Biology, Biochemistry or Analytical Chemistry; experience in a Biopharmaceutical working environment
Excellent pipetting skills
Experience in cell biology (immunology is a plus)
Extensive experience in cell culture (primary cells and cell lines), cell engineering (for assay development) cell culture techniques, protein therapeutic characterization, and a variety of cell-based and non-cell based assay formats is preferred.
Broad experience in routine cell biology laboratory techniques including flow cytometry, ELISA, etc.
Previous experience with T cell functional characterization and antibody-based lead molecule discovery are pluses.
Highly motivated self-starter with strong presence, work ethic, exceptional interpersonal skills, and focus.
Deep knowledge, and keen intellect for integrating novel science and emerging technologies to address complex problems.
Outstanding communication skills with the ability to build transparent and collaborative relationships across the company and with other stakeholders of the company.
Strong computer, scientific, and organizational skills.
Excellent communication (oral and written) and attention to detail; excellent project management skills including the ability to manage multiple projects, and strategically prioritize activities.
Ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude.
Ability to think creatively, learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Experienced in analyzing, troubleshooting, and documenting experimental results.

Basic minimum qualifications:
Bachelor’s or Master’s degree in Cell Biology, Biology, Biochemistry, Molecular Biology, Immunology, or related field
Preferred: At least two years of relevant experience within a pharmaceutical/biotechnology organization
Experience in scientific writing including generation of testing reports, analytical methods, and method development reports.

Top Must have Skill Sets:

Excellent pipetting skills and extensive experience in cell culture, (primary cells and cell lines),
Tissue culture experience
Lab experience
cell culture techniques, protein therapeutic characterization, and a variety of cell-based and non-cell-based assay formats is preferred (experience with T cell functional characterization and antibody-based lead molecule discovery are pluses)
Outstanding communication skills with the ability to build transparent and collaborative relationships across the company and with other stakeholders of the company with strong computer, scientific, and organizational skills, excellent oral and written and attention to detail; excellent project management skills including the ability to manage multiple projects, and strategically prioritize activities including accurate, timely and robust documentation of experiments and reports into electronic laboratory notebook.
Ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude; ability to think creatively, learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies; experience with analyzing, troubleshooting, and documenting experimental results

Day-To-Day Responsibilities:

Working in Biosafety cabinet; pipetting; conducting cell culture experiments (primary cells and cell lines), and developing assays, isolation and characterization of therapeutic proteins.
Conducting cell-based and non-cell-based assay such as PBMC and T cell functional characterization, flow cytometry and ELISA, etc.
Applying robust interpersonal and collaborative skills to work with internal stakeholders to communicate data and results
Applying your strong computer, scientific, organizational skills, attention to detail and excellent project management skills to manage multiple projects, and strategically prioritize activities
Applying creativity and strong work ethic to maintain Quality through accurate documentation and record keeping, following instructions, and complying with company policies to analyze, troubleshoot, and document experimental results.

Employee Value Proposition:
The person in this role will work with a world class organization and help produce quality, safe products.

Red Flags:
Mistakes on resume/cv
No cell culture experience

Interview Process:
1. First round meeting with candidates virtually by webex as an initial screen with 2 members of the team
2. Second sound of selected candidates (1-3) to meet virtually with the Attribute Impact Team by webex.

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 look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

Principal Device Quality Engineer - IVD devices SME (JP9691-C) - Cambridge, MA

Thu, 20 Jan 2022 23:30:19 GMT

Job Title: Principal Device Quality Engineer - IVD devices SME (JP9691)
Location: Thousand Oaks, California OR San Francisco, California OR Cambridge, Massachusetts
Employment Type: Contract
Business Unit: Digital Health & Diagnostics Quality
Duration: 12 months with likely extensions
Job posting date: 1/20/2022
Note: Remote until Covid restrictions are lifted.

3 Key Consulting is hiring a Principal Device Quality Engineer - IVD devices SME for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:

Manager is open to candidates working remotely until restrictions are lifted
Candidates must have 5+ years working with IVD devices. Must be IVD subject matter expert.
This key role in the Quality organization will assist with the co-development, commercialization, and lifecycle management for diagnostic and companion diagnostic devices (IVD’s) to support the client therapeutics.
The role will be highly visible, interacting with cross-functional internal European and U.S. management and technical team members, and multiple IVD manufacturers, to prepare for and execute activities including manufacturer due diligence and evaluation, manufacturer auditing, design control, inspection readiness and lifecycle management.
The position will report to a member of the Device Quality department leadership team and provide thought leadership and current best practices surrounding considerations and continued development of internal processes related to control of IVDs. The staff member will report to the Corporate Quality function at the Thousand Oaks, California headquarters.
Train and educate key functional partners and management on regional and international IVD requirements, standards and regulations
Suggest and participate in improvements to the quality system, particularly related to IVDs
Provide Quality leadership for regulatory interactions for IVDs
Review and approve procedures and work Instructions
Specifically, this role will employ quality principles and company’s procedures including but not limited to the areas of Purchasing Controls, Design Controls, Change Controls and NC/CAPA, Risk Management, Human Factor Engineering, Process Validation, and Manufacturing and Distribution, to ensure co-development and sustainment of IVD products complies with applicable regulations and standards. Such devices may include (but are not limited to):
- IVDs intended to diagnose a condition client’s therapeutics treat
- IVDs intended for client drug titration
- IVDs intended to monitor a condition client’s therapeutics treat

Basic Qualifications

Doctorate degree and 2 years of directly related experience OR
Master’s degree and 6 years of directly related experience OR
Bachelor’s degree and 8 years of directly related experience OR
Associate’s degree and 10 years of directly related experience OR
High school diploma / GED and 12 years of directly related experience

Preferred Qualifications

BS in Science/Engineering - preferably chemistry, biology, software, mechanical, or electrical engineering.
5+ years of Quality, Engineering or Operations experience in the IVD medical device industry
Experience with quality systems including: 21 CFR 820, European Medical Device Directives (MDD) and Medical Device Regulations (MDR), IEC 62304, ISO 13485, ISO 14971, IEC 62366.
Knowledge of Medical Device Design Controls, particularly for in vitro devices. Experience working in in vitro device development, manufacturing or validation function is a plus.
Experience with designing and executing IVD clinical trials is a plus, particularly as part of a co-development agreement between a biopharmaceutical manufacturer and an IVD manufacturer
Experience in interacting with notified bodies and regulatory agencies in an inspection setting for In Vitro devices.
Strong project management skills including the ability to manage multiple workflows simultaneously and work within business processes as well as quality management systems
Ability to work in a cross-functional team environment and to influence personnel across functions and at all levels
High personal integrity with a positive attitude and a strong work ethic
Experience in driving improvement and implementing change
Demonstrated the ability to effectively work independently and with individuals located in remote locations
Inter-personal skills and demonstrated ability to teach lay staff quality principles

Top Must have Skill Sets:

Audits / inspections / quality agreements (purchasing controls)
Quality or Technical experience within a GMP regulated IVD manufacturer (IVDD, IVDR, FDA QSR)
Ability to teach high performing staff who have a device quality background, but not necessarily IVD experience

Employee Value Proposition:
Compelling, active and growing area of interest and innovation within precision medicine
Ability to gain experience from the “pharma” side of IVD and companion diagnostics
Broad exposure to many innovative IVD manufacturers

Red Flags:

No or minimal practical experience for IVD manufacturers
“Consultant” view, rather than “executor” view. We need people to do actual work, not give advice on policy and strategy
Poor communicator

Interview Process:
Initial phone screen followed by 3 or 4 behavioral interviews (combined, 1 day).

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 look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

Human Factors/Usability Technician - (JP9684) - Thousand Oaks, CA

Tue, 18 Jan 2022 17:28:38 GMT

Job Title: Human Factors/Usability Technician - (JP9684)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Pre-pivotal AS
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 1/18/2022
Notes: Onsite M-F Thousand Oaks, CA. This position requires up to 10% yearly travel mostly local and domestic.

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

Job Description:
Ideal candidate- Bachelor’s or Master’s degree in Human Factors/Usability, User Centered Design, Psychology, Engineering, Operations or Industrial Design, or similar area. Some experience in device development engineering in a medical device, or other regulated environment or related field is preferred. Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.).

The Human Factors/Usability technician will be an integral part of the HFE/UE department and will contribute to activities of client combination drug delivery. The position will be working with HFE/UE personnel in close collaboration to coordinate HFE project activities by overseeing logistics. This role will assist with human factors department personnel with study logistics, support on material ordering, shipping and inventory of supplies and models, working with vendors to procure stimuli, expediting IRB protocols, assisting with video editing and organization of HFE research materials in usability data capture and analysis. HF/U technician will support appropriate human factors and usability engineering activities for the department and will have the opportunity to participate on various activities across the product life cycle in an FDA regulated environment.

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

Top Must Have Skills:

See job posting skills: Communication, technically savvy, likes problem solving.
Bachelor’s or Master’s degree in Human Factors/Usability, User Centered Design, Psychology, Engineering, Operations or Industrial Design, or similar area.
Some experience in device development engineering in a medical device, or other regulated environment or related field is preferred.
Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.)

Day to Day Responsibilities:
They will be required to train on our process and system. They will learn what HF does, interact with the team to understand the work, and where they can help with the task as described in the job description.

Primary point of contact for research logistics with vendors, internal stakeholders, and research participants recruitment.
Working with lead HFE personnel to define successful screener criteria, coordinate study dates, identifying and secure research facilities, and coordinate study participant recruitment activities with vendors,
Managing protocol submissions with Internal Review Board (IRB) and working on change requests to ensure HF studies are executed on time,
Assist in coordinating user studies, support on material ordering, shipping and inventory of supplies,
Setup and dismantle audio/video equipment and recording software for user testing,
Support departmental activities including video edits, study material preparation, and document management,
This person will be responsible for housing study materials and ensuring that HFE department is following client SOPs, including working with vendors to procure stimuli,
Facilitate meetings, manage communications, escalating potential issues which may impact timelines or scope,
Periodically explore new novel tools for helping with research project organization,
Perform data verification for reports,
Other duties as assigned.

Basic Qualifications:

Associate degree or working toward a Bachelor’s or Masters’ in Human Factors/Usability, User Centered Design, Psychology, Engineering, Operations or Industrial Design, or similar area
Ability to work in a high paced work environment.
Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.)

Preferred Qualifications:

Bachelor’s or Master’s degree in Human Factors/Usability, User Centered Design, Psychology, Engineering, Operations or Industrial Design, or similar area
Strong oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products
Experience and desire for working with inter-disciplinary development teams.
Some experience in device development engineering in a medical device, or other regulated environment or related field is preferred.
Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.)

Employee Value Proposition:
This department is the best seat in the house. They can see a good mix of action. Learn to self-organize and oversee the tech process.

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.

Senior Associate, Scientific Lab HPLC - (JP9677) - Thousand Oaks, CA

Tue, 18 Jan 2022 15:16:17 GMT

Job Title: Senior Associate, Scientific Lab HPLC - (JP9677)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Pivotal AS
Duration: 2+ years (with likely extensions and/or conversion to permanent)
Posting Date: 1/18/2022
Notes: Onsite

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

Job Description:

Obtain assignment and follow scientific direction of client staff, flag issues and seek guidance appropriately
Perform testing and data review for HPLC/UHPLC (high and ultra-high performance liquid chromatography), IEX (ion exchange), SEC (size-exclusion chromatography), CE (capillary electrophoresis), glycan mapping, peptide mapping, and mass spectrometry
Execute method development and qualification studies as well as protein characterization experiments with guidance from senior staff members
Demonstrate independence and ability to produce quality results under minimal direction
Generate complete, accurate, and concise documentation using electronic systems and laboratory notebooks
High energy individual who can multi-task and handle a fast-pace, dynamic work environment
Operate specialized laboratory equipment and instrumentation
Perform general laboratory housekeeping activities
Complete training on assigned tasks
Participate in quality improvement efforts
Strive to achieve excellent client service
Comply with safety guidelines and site specific procedures which include but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books
Interact with multiple functional areas in a highly matrixed-team environment, which may include Manufacturing, Process Development, IS, Facilities, Engineering, and Quality Control

Why is the Position Open?
Backfill for two CW's

Top Must Have Skills:

HPLC experience
Analytical Method Development experiences
Interpersonal skills: Communication, team player

Day to Day Responsibilities:

To follow the direction of experienced staff in pivotal AS group to plan and execute experiments supporting method development and product characterization
Author technical reports (method development reports, technical assessment)
Communicate to team on progress of experiments via meetings (both in person or via Webex or Skype meetings)

Basic Qualifications:

B.S. or M.S. degree in Analytical Chemistry, Physical, Life Sciences or related technical discipline
1-3 years experience performing analytical testing

Preferred Qualifications:

Experience executing analytical test methods in one or more of the following areas:

HPLC/UHPLC (high and ultra-high performance liquid chromatography), IEX (ion exchange chromatography), SEC (size exclusion chromatography), CE (capillary electrophoresis), glycan mapping, peptide mapping, and mass spectrometry
Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories and deepens technical knowledge through exposure and continuous learning
Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Practical experience with protein chemistry, theoretical knowledge of protein chemistry
Experience with operation, maintenance, and troubleshooting of laboratory equipment and instrumentation related to analytical testing
Ability to work independently and as part of a team with internal and external clients, self motivation, adaptability, and a positive attitude
Strong organizational and time management skills
Ability to learn new techniques, perform multiple tasks simultaneously, follow instructions, and comply with company policies
Ability to address client questions independently with sound scientific judgements on the work they reported to the clients

Red Flags:

Poor communication skills
Jumping from job to job (less than 2 years per job)
Bachelors: Biology and chemistry (not looking for economics bkg)
1-2 years in lab experience outside of school

Sourcing Associate - ESS (JP9649) - Tampa, FL

Thu, 13 Jan 2022 21:47:46 GMT

Job Title: Sourcing Associate - ESS (JP9649)
Location: Tampa, FL.
Employment Type: Contract
Business Unit: Sourcing Excellence
Duration: 12 months with likely extensions and/or conversion to permanent
Rate: $20-22/Hr W2
Posting Date: 1/13/2022

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

Ideal candidate: 3+ YOE of sourcing in regulated industry; banking, pharma, est. Must have proven Customer Service Experience

Job Description:
Primary responsibilities include the following:

Executing Tail Spend Sourcing Strategies
Support supplier analysis and market intelligence activities
Manage Request for Proposal and Quotation processes (eRFX)
Consistently document and guide sourcing execution in designated tools
Ensure sourcing tactics drive value in specific functional business environments
Delivering Value for Customers
Understand business goals and interpret customer needs to identify potential opportunities
Partner with colleagues in various business areas as appropriate
Managing Contracts:
- Ensure contract policies are followed, compliance metrics are met or exceeded
- Inform stakeholders on contracting policies and procedures, providing support and corrective actions where required
- Lead contracting activities including selecting appropriate contract templates and effectively negotiating business terms

Basic Qualifications:
Bachelor’s degree OR
Associate’s degree and 2 years of Sourcing, Contracting, Customer Service, and/or Project Management experience

Preferred Qualifications:

Combination of: Sourcing, Contracting, Customer Service and/or Project Management
Broad knowledge of the market forces shaping a customer’s business context (e.g. supplier base, sources of competitive advantage)
Demonstrated experience working within a set of guidelines in a fast-paced environment
Demonstrated success ensuring requirements are met with a customer-centric mindset
Analytical & Technical
Ability to influence to drive desired results
Ability to analyze, summarize, and present insights based on the needs of the audience
Change Management:
- Independent self-starter with an interest in or working understanding of broad business functions
- Demonstrated track record of identifying root causes to issues and proactively problem solving
- Demonstrated success in partnering cross-functionally
- Compelling and persuasive communicator (oral and written) with excellent interpersonal skills
- The invaluable contributions of our talented Tampa team will help us develop the vital and innovative medicines that treat serious illness and unmet medical needs around the globe.

Why is the Position Open?
backfill

Top Must Have Skills:
Customer Service, Results Driven, Project Management

Day to Day Responsibilities:
Executing Tail Spend Sourcing Strategies, Delivering Value for Customers, Ensure contract policies are followed, compliance metrics are met or exceeded

Employee Value Proposition:
Great team. Great opportunity for entering sourcing with ability to work with verticals vast array of experience fast paced never working on the same project everyday

Red Flags:
Job jumping

Interview process:
Video interview with hiring manager, 2nd round - panel interview with stakeholders. Immediate interview availability

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 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 - Packaging - (JP9673) - Thousand Oaks, CA

Thu, 13 Jan 2022 14:30:28 GMT

Job Title: Engineer - Packaging - (JP9673)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: Design and Development
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 1/13/2022
Notes: Remote but must be able to go onsite when asked (local candidates only).

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 Packaging Engineering group under Final Product Technologies 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.

Why is the Position Open?
Planned project.

Top Must Have Skills:

Some packaging experience is needed (work, internship, education).
Familiarity with Material Testing standards, requirements and equipment.
BS Packaging, Mechanical Engineering, Chemical Engineering or Life Sciences.

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.

Employee Value Proposition:
The chance to work with a team of industry professionals as well as a likely extension. This is a backfill for someone who converted to permanent.

Red Flags:
No relevant experience.

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.

Associate, Biopharma Lab-based (JP9644) - Thousand Oaks, CA

Fri, 07 Jan 2022 12:18:30 GMT

Job Title: Associate, Biopharma - Lab-based (JP9644)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months; Possible extension for an additional 1-2 years.
Rate: $20-22/Hr W2.
Job posting date: 1/7/2022
Note: Onsite Essential

3 Key Consulting is hiring an Associate Scientist for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:

We are currently seeking a research associate for the Drug Product Technologies group in Thousand Oaks, CA.
A fundamental understanding of protein chemistry, formulation, and biophysical characterization is desired.
Ideal Candidate must have 1+ year of industry or academia in a lab setting with Pipetting, Sample prep & handling, HPLC Chromatography, Protein sample analysis (ideal).
BS degree in pharmaceutics, biochemistry, chemistry, or related life sciences discipline.
A strong understanding of protein biochemistry and protein structure, as well as significant experience with basic laboratory skills and biophysical techniques related to protein analysis is essential.
A background in protein solution manipulation (e.g., pipetting, dialysis, concentration) and HPLC analysis is expected.
Experience with visible and sub-visible particle analysis and other analytical methods is desirable.
The successful candidate will perform experiments related to the development of formulations for therapeutic proteins, including stability testing and analytical characterization.
The candidate will join a team of investigators using a variety of biochemical and biophysical techniques and will be involved in the design and execution of experiments.
Responsibilities will include detailed record keeping in electronic laboratory notebooks, analysis, and interpretation of experimental data.

Basic qualifications
BS degree in pharmaceutics, biochemistry, chemistry, or related life sciences discipline. A strong understanding of protein biochemistry and protein structure, as well as significant experience with basic laboratory skills and biophysical techniques related to protein analysis is essential.
The applicants must be motivated, have good problem-solving skills, and an aptitude to learn and implement new techniques/skills.
The candidate should be well organized and proficient in detailed record-keeping, have excellent written and oral communication skills, and be capable of working efficiently in teams and independently

Top Must have Skill Sets:

HPLC
Pipetting
Protein sample analysis

Employee Value Proposition:
The chance to gain valuable hands-on work experience from an industry leader, as well as a possible extension.

Red Flags:
No experience in HPLC/chromatography

Interview Process:
5~10 Phone Screen
2~3 Final Round Virtual Onsite

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 look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

Quality Assurance Associate, Biopharma Medical Device (JP9524) - Thousand Oaks, CA

Tue, 14 Dec 2021 18:18:38 GMT

Job Title: Quality Assurance Associate, Biopharma Medical Device (JP9524)
Location: Thousand Oaks, CA. Onsite
Employment Type: Contract
Business Unit: Plant Quality Assurance Incoming and Packaging
Duration: 2 years with possible extension or conversion to FTE
Posting Date: 12/14/2021

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

Job Description:
This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace, deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is the potential for role expansion into support of a product distribution function.

Skills: quality assurance or manufacturing experience in the pharmaceutical or medical device industry

Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have no foundation. Must be able to methodically and meticulously inspect printed materials for print quality defects, clinical product components (e.g. syringes and vials) for physical defects, and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities, such that the team members must be confident verbal communicators able to discuss responsibilities, divide them, reassess them, and potentially reassign them throughout the day or week.

Top Must-Have Skill Sets:

1 + GMP processes and documentation experience
Good Manufacturing practices
Inspection and QA background.
Attention to detail; assign expiration dates on labels, providing info on labels, and documentation
Packaging experience, is preferred

Day to Day Responsibilities:
Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace, deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is also the potential for role expansion into support of a product distribution function.

Employee Value Proposition:
Good team atmosphere and supportive team
Opportunity to learn and grow

Red Flags:
* Jumping from position to position
* Lack of attention of details
* A minimum of 1 year of experience in Quality Assurance

Interview process:
Phone screen
Virtual 1:1 (45 minutes- 60) with panel

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.