Project Engineer

Location: Fremont, CA
Duration: 6 Months Contract
Job Type: Contract | Full-Time

Sigma Inc. is hiring a Project Engineer (Senior Equipment Engineer) to support a leading biopharmaceutical manufacturing environment in Fremont, CA. This role serves as the technical lead for process equipment systems across Bulk Drug Substance (BDS), Drug Product (DP), and Process Science (PS) operations.

You will play a critical role in equipment troubleshooting, project execution, and GMP compliance, while leading CAPEX/OPEX and continuous improvement initiatives.

• Act as Engineering Technical Lead for process systems and equipment
• Support Upstream & Downstream BDS, including bioreactors, centrifuges, and chromatography systems
• Lead and execute CAPEX, OPEX, and Continuous Improvement (CI) projects
• Own and manage:
  • Change control
  • Deviations & CAPA
  • Risk assessments
• Troubleshoot process and equipment issues during qualification and production
• Lead startup, commissioning, and qualification activities
• Develop and review:
  • SOPs
  • Project execution plans
  • Commissioning documentation
• Act as System Owner for equipment performance and compliance
• Oversee contractors and ensure project deliverables
• Ensure compliance with GMP, OSHA, and FDA regulations

Experience with:

• Bioreactors
• Centrifuges
• Chromatography skids & columns
• CIP/SIP systems
• Prep & hold tanks
• Filling & packaging equipment

• Bachelors Degree in Engineering + 510 years experience
  (OR Masters + 5+ years OR P.E. License)
• 4+ years in GMP manufacturing environment
• 5+ years hands-on experience with process equipment/systems
• Strong experience in:
  • Commissioning & qualification
  • Root cause analysis & troubleshooting
  • CAPA, deviation & change control
  • Risk assessment & project leadership
• Excellent written & verbal communication skills