Job Details

Senior Engineer, Equipment (Project Engineer III)

📍 Fremont, CA (Onsite)

📅 6-Month Contract (High Likelihood of Extension)

We are seeking a Senior Engineer, Equipment to serve as the Engineering technical lead supporting BulkDrug Substance (BDS), Drug Product (DP), and/or Process Science (PS) systems within a GMP-regulated manufacturing environment.

This role supports upstream and downstream BDS operations as well as filling and packaging equipment, and will act as a key consultant for troubleshooting, system qualification, and project execution from feasibility through handover.

Key Responsibilities

Technical Expertise

• Serve as Engineering technical lead for process systems and equipment including:
• Bioreactors, centrifuges, chromatography skids/columns
• Prep and hold tanks, CIP/SIP systems
• Filling and packaging equipment
• Troubleshoot equipment and process issues through qualification and system release
• Perform technical analysis including:
• Equipment utilization and capacity assessments
• Value engineering and sustainable design
• Constructability and new technology evaluation

Project Management

• Lead and/or support CAPEX, OPEX, and continuous improvement projects
• Develop and review project execution plans
• Own risk assessments for new systems and modifications to existing systems
• Lead startup and commissioning activities:
• Approve commissioning reports
• Review/approve turnover packages (TOPs)
• Create/review/approve SOPs and protocols
• Provide resource estimates and manage project timelines, cost, and quality
• Oversee contractors and provide technical direction on-site

Optimization & Compliance

• Own technical optimization within assigned systems/area
• Ensure all equipment, documentation, and processes meet GMP, FDA, OSHA, and EHS standards
• Lead and execute:
• Deviations, CAPA, change control, and risk assessments (quality, business, safety)
• Support audit readiness and regulatory inspections

Global Engineering Collaboration

• Contribute to implementation of engineering best practices and standards
• Participate in peer reviews and global engineering initiatives
• Support consistent project documentation and execution standards

Qualifications & Experience

• Bachelor's degree in Engineering with 5–10 years of experience, or
• Master's degree in Engineering with 5+ years of experience, or P.E. license
• Minimum 4+ years in a GMP manufacturing environment
• Minimum 5+ years of hands-on experience with process systems/equipment
• Strong expertise in:
• Troubleshooting technical issues
• Root cause analysis and risk assessment
• Change control, deviation management, and CAPA
• Commissioning, qualification, and system startup
• Proven ability to lead CAPEX or continuous improvement projects

Additional Details

• Ability to balance competing priorities in a fast-paced environment
• Strong collaboration across cross-functional teams (Manufacturing, Quality, Supply Chain, Finance, IT)
• Experience working with contractors, vendors, auditors, and external partners
• Primarily office-based with regular presence on the manufacturing floor
• Some domestic and international travel may be required

If you're interested, apply directly and include your resume.