Engineer, Biotech
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 3, 2026
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Job Description:
Job Title: Engineer, Biotech Location: Thousand Oaks, CA.
Employment Type: Contract Duration: 12 months with possible
extensions or conversion to FTE Rate : $40 - $44/hour Posting Date:
05/22/2024. Summary: 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. Responsibilities: 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 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 Preferred
Qualifications / Skills / Experience 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
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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, West Covina , Engineer, Biotech, Engineering , Thousand Oaks, California
