Apply to Engineer, Facilities, Equipment and Analytical support (JP11900)

Job Title: Engineer, Facilities, Equipment and Analytical support (JP11900)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Substance Supply
Employment Type: Contract
Duration: 1+ year(s) (with possible extensions)
Rate: $38 - $42/hour W2
Posting Date: 10/18/2023
Notes: Only qualified candidates need apply. Fully onsite.

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

Job Description:
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at clients site in Thousand Oaks. The engineer will lead activities in alignment with clients’s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition, the engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.

Top Must Have Skill Sets:

Fundamental client Leadership and Values -preferable to see former client worker
Good Communication / Safety / Quality Focused
Fundamental Technical Knowledge.
Person will be working in a manufacturing environment but in this posting, we are looking for an engineer with strong ANALYTICAL skills and background

Day to Day Responsibilities:
The engineer will lead activities in alignment with client’s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment. The engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition, the engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and investigate root causes of equipment issues. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization. The Engineer role will provide direct engineering technical support as follows:

Be individually accountable for the verification deliverables on key capital projects.
Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
Oversee development of validation protocols in line with CQP and cGMP standards.
Lead, evaluate, and manage performance of contract resources.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Act as a liaison between Engineering, Manufacturing, and Quality Assurance during project planning, execution, and closeout.
Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
Ensure safety during commissioning, validation, maintenance, and manufacturing activities.
Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.
Conduct and document periodic equipment validation reviews.
Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)

Related Activities:

Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.
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
Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
Participate in internal audits and assess risks in conjunction with QA.
Assist in developing and maintaining metrics related to equipment performance
Provide technical expertise to develop reliability improvement plan including design requirements, maintenance strategy, spare part procurement.
Lead improvement implementation plans while following safety requirements
Assist with equipment maintenance and troubleshooting during project duration
Introduce and implement new analytical systems to improve reliability when needed. Lead implementation plan to ensure new systems are implemented per client’s requirement.
Contact vendors as needed to understand and assess any change impact (to equip, utility, facility) as improvements are planned and executed.
Develop GMP documentation following good documentation practices including validation plans and standard operating procedures.

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

Preferred Qualifications:

Bachelor's degree in engineering or another science-related field
2+ years of relevant work 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
Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
Demonstrated strong communication and technical writing skills
Strengths in facilitation and collaboration / networking with cross-functional groups
Experience in developing SOPs and delivering training
Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
Problem solving skills using scientific and engineering methods and investigative skills for root cause analysis.
Availability to support outside regular hours as needed
Demonstrate skills in the following areas:
- Problem solving and applied engineering.
- Basic technical presentations.
- Personal organization.
- Adapting to and managing change.
- Project and document management systems (CDOCS, E-Builder, PCS, BMS and QEMS).
- Validated GMP management systems (Maximo CMMS, Trackwise)
- Project management and cost development
- Conflict Resolution
- Leadership and team building

Red Flags:

Safety not recognized as top priority
Poor communication
Has issues under stressful situations
Blames other for negative situations

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.