Project Engineer

We are seeking a Senior Equipment Engineer (Project Manager) to support biopharmaceutical manufacturing operations within Bulk Drug Substance (BDS), Drug Product (DP), and Process Science systems. This individual will serve as the technical lead for process equipment, supporting troubleshooting, commissioning, qualification, CAPEX/continuous improvement projects, and GMP manufacturing operations. The ideal candidate will have strong hands-on experience with upstream/downstream process equipment in a GMP-regulated environment and be comfortable leading technical investigations, change controls, deviations, and startup activities.

Location:

Fremont, California Contract Length:

6+

Month Contract Schedule:

Monday-Friday | 40 hours/week

Pay Rate:

$95.00-$110.00/hour DOE Key Responsibilities Serve as technical lead for process equipment and manufacturing systems Troubleshoot equipment/process issues during qualification, startup, and production Lead and support CAPEX, OPEX, and continuous improvement projects from feasibility through handoff Support commissioning, startup, qualification, and system release activities Own or support deviations, CAPAs, change controls, and risk assessments Act as System Owner for manufacturing/process equipment as needed Review and approve SOPs, protocols, commissioning documentation, and project execution plans Oversee contractors and provide technical guidance during project execution Ensure compliance with GMP, FDA, OSHA, quality, and safety requirements Collaborate cross-functionally with Manufacturing, Quality, Validation, Facilities, Automation, and Engineering teams Equipment & Systems Experience Hands-on experience supporting and troubleshooting process equipment including: Bioreactors Centrifuges Chromatography skids and columns Prep and hold tanks CIP/SIP systems Filling and packaging equipment Qualifications Bachelor's degree in Engineering with 5-10 years of related experience OR Master's degree with 5+ years of experience Minimum 4+ years of experience in GMP manufacturing environments Strong technical knowledge of biopharmaceutical process equipment and systems Experience leading investigations, risk assessments, startup/commissioning, and qualification activities Experience owning deviations, CAPAs, and change controls Proven project leadership experience supporting CAPEX or continuous improvement initiatives Excellent communication and cross-functional collaboration skills This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! #LI-CS1