Job Description
Job Description
Job Title: Process Engineer – GMP
Location: Vacaville, CA – 100% Onsite
Duration: 20+ Months
Job Type: W2
Work Authorization: US Citizens or Green Card holders only
Experience: 5+ years, up to 10 years
Position Overview:
Our client, a leading CDMO, is expanding its engineering organization to support a multi-year capital improvement initiative at its Vacaville, California manufacturing campus. The Process Engineer will join a newly established onsite engineering team focused on modernizing legacy manufacturing systems originally installed in the mid-1990s.
The role will support brownfield capital projects involving upgrades and replacement of upstream and downstream biologics manufacturing equipment and critical process systems while minimizing disruption to GMP operations. Current projects include modernization of an older cell culture facility and replacement of downstream equipment such as VRF skids, CIP skids, and fillers.
Important Duties:
• Provide day-to-day process engineering support for upstream and downstream biologics manufacturing operations in a GMP environment.
• Support modernization, replacement, and modification of legacy manufacturing equipment and process systems.
• Assist Lead Process Engineers with engineering design packages, system modifications, and technical documentation.
• Develop and review PFDs, P&IDs, equipment specifications, engineering calculations, and technical reports.
• Support engineering construction and field implementation requirements.
• Review engineering drawings, vendor documentation, and equipment specifications.
• Coordinate with Capital Projects, Operations, Manufacturing, Maintenance, Validation, and Engineering teams.
• Support equipment commissioning, startup, qualification, change control, and engineering turnover activities.
• Participate in FAT, SAT, commissioning, startup, and equipment implementation activities.
• Troubleshoot process equipment and manufacturing systems and support resolution of technical issues.
• Ensure engineering activities comply with cGMP requirements, safety standards, and applicable engineering practices.
Required Skills:
• 5+ years of pharmaceutical or biotechnology process engineering experience, ideally up to 10 years.
• Bachelor's degree in Engineering preferred; scientific degrees may be considered with strong relevant industry experience.
• Strong experience supporting upstream and/or downstream biologics manufacturing in GMP environments.
• Experience with process equipment and manufacturing systems in pharmaceutical or biotechnology facilities.
• Experience with WFI, process piping, HVAC, chilled water, clean steam, and CIP/SIP systems.
• Experience supporting CapEx, brownfield, equipment upgrade, or facility modernization projects in GMP facilities.
• Experience with PFDs, P&IDs, engineering drawings, equipment specifications, and technical documentation.
• Experience with commissioning, startup, FAT/SAT, qualification, and engineering turnover.
• Strong troubleshooting and cross-functional communication skills.
• Must be able to work 100% onsite in Vacaville, CA.
• Must be a US Citizen or Green Card holder.
• Candidates must be actively recruited for this opportunity and should not be submitted solely from an existing bench.