Engineer Senior - Technical Support GMP Manufacturing (JP12779)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 3, 2026
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Job Description:
Job Title: Engineer Senior Technical Support GMP Manufacturing
(JP12779) Location: Thousand Oaks, CA. 91320 Business Unit:
Facilities and Equipment Drug Substance Supply Employment Type:
Contract Duration: 1 years (with possible extensions) Rate : $45 -
$50/Hr, with benefits Posting Date: 6/24/2024. Notes: Only
qualified candidates need apply. Fully onsite. Standard business
hours 3 Key Consulting is hiring! We are recruiting an Engineer
Senior for a consulting engagement with our direct client, a
leading global biotechnology company. Job Description: Looking for
hands on *STRONG* engineer experience with proper training/
background in technical side/ mathematics. NOT LOOKING for quality
lab/ bench top/ science work. The job seeker needs to be practical
with troubleshooting and be able to hold a technical conversation.
Transferrable Industry backgrounds: Drug substance/ pharma /
chemical/ oil refinery/ mechanical This engineering position
supports manufacturing activities associated with cGMP equipment
and facilities at our client’s Thousand Oaks, CA. facility. The
senior engineer works in partnership with the automation,
maintenance, project management, corporate engineering, and
manufacturing to develop and oversee the operation and reliability
of equipment while driving safety and quality compliance. The
engineer will support the department and capital projects and
provide data to support business cases and long term strategy. The
Senior Engineer role will provide direct engineering technical
support as follows: Demonstrating role modeling of leadership
behaviors and positive values to create a positive working
environment. Be individually accountable for manufacturing
equipment reliability and deliverables on key capital projects to
deliver business targets and deliverables Assist in the
identification of critical quality parameters and process
attributes for new equipment or facility modifications. Suggest
design modifications to address risks and design in quality and
safety. Develop the commissioning strategy based on the URS and
Quality Risk Assessment for Automation and Equipment Systems
(QRAES) to validate equipment design while minimizing project cost
and schedule impact (risk-based approach). Oversee development of
validation protocols in line with CQP, Automation Systems Delivery
SOPs, and cGMP standards. Recommend, evaluate, and manage
performance of contract resources Provide oversight for
verification deliverables developed by outsourced/contract
verification staff. Act as a liaison between engineering and
quality assurance during project planning, execution, and closeout
Ensure that work executed with safety compliant practices and
documented in accordance with cGMP good documentation Review and
approve the commissioning reports, maintenance practices and parts,
and drive productivity improvement 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 and
maintenance Provide coaching and guidance to project teams and
engineers using risk-based approaches Defend the equipment-specific
calibration, maintenance, & validation as required during
regulatory inspections Participate in internal audits and assess in
conjunction with quality assurance Assist in developing and
maintaining business metric performance Top Must Have Skill Sets:
Looking for hands on *STRONG* engineer experience with proper
training/ background in technical side/ mathematics. (NOT LOOKING
for quality lab/ bench top/ science work). The job seeker needs to
be practical with troubleshooting and be able to hold a technical
conversation. Transferrable Industry backgrounds: Drug substance/
pharma / chemical/ oil refinery/ mechanical Troubleshooting GMP
Manufacturing process equipment. Statistical Process Control (SPC),
Quality Management Systems (QMS) - Change Control, Project
Management, Lean Six Sigma, SOP/Batch Record Development, cGMP
Regulatory Compliance, Process Development, Process Validation.
Bioprocess development and scaleup (cell culture, harvest
(isolation), and product assays). Process characterization
Technical writing. Tech transfer to cGMP manufacturing and training
personnel Basic Qualifications: Doctorate degree OR Master’s degree
& 3 years of engineering and/or manufacturing experience OR
Bachelor’s degree & 5 years of engineering and/or manufacturing
experience OR associate’s degree & 10 years of engineering and/or
manufacturing experience OR High school diploma / GED & 12 years of
engineering and/or manufacturing experience. Preferred
Qualifications: Bachelor's degree in engineering or another
science-related field 7 years of relevant work experience with 5
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
Experience implementing risk-based verification on major GMP
process equipment / automation projects, including validation
protocol development and execution Understanding and awareness of
industry/regulatory trends for verification/validation Experience
with combination product / medical device quality systems
verification Strong process equipment knowledge – cell culture,
fermentation, purification, filling, and packaging Strong process
automation knowledge – understanding of automation infrastructure,
current technologies, and automation project execution /
verification. Knowledge of Delta V, Rockwell, and Plant Information
Systems is a plus Demonstrated strong communication and technical
writing skills Strengths in facilitation and collaboration /
networking Experience in developing SOPs and delivering training
Individual must be a team player prepared to work in and embrace a
team-based culture that relies on collaboration for effective
decision-making Proven track record of applying process improvement
methodologies to mature and improve business processes (e.g. PDCA,
LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
Why is the Position Open? Supplement additional workload on team
Red Flags: Resumes should not be brief and have proven documented
experience Poor Communication Poor Leadership Poor Teamwork
Interview Process: WebEx We invite qualified candidates to send
your resume to resumes@3keyconsulting.com . If you decide that
you’re not interested in pursuing this particular position, please
feel free to take a look at the other positions on our website
www.3keyconsulting.com/careers. You are also welcome to share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Burbank , Engineer Senior - Technical Support GMP Manufacturing (JP12779), Engineering , Thousand Oaks, California
