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!

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