Consultant, Commissioning, Qualification & Startup Lead - Biopharma
Listed on 2026-08-22
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Engineering
Pharma Engineer, Validation Engineer, Quality Engineering
Senior Commissioning, Qualification & Startup (CQV) Lead – Biopharma Construction
12+ Month Contract | Onsite | Westchester County, NY
GForce Life Sciences has partnered with a leading global pharmaceutical company to identify a Senior Commissioning, Qualification & Startup (CQV) Lead to support the construction and startup of a new biopharmaceutical R&D facility.
As the Owner's Representative
, you'll ensure the facility, laboratory equipment, clean rooms, utilities, and building systems are designed, installed, commissioned, qualified, and ready for day-one operations. You'll partner with Engineering, Construction, Quality, Facilities, and Operations teams to deliver a compliant, fully operational research facility.
- Lead commissioning, qualification, and startup activities for a large-scale biopharmaceutical capital project.
- Review engineering designs, equipment packages, and construction documents to ensure functionality and GMP compliance.
- Coordinate installation, startup, FAT/SAT, commissioning, IOQ, and facility turnover activities.
- Resolve technical issues, RFIs, NCRs, and field changes throughout construction.
- Ensure turnover documentation, SOPs, training, maintenance plans, and operational readiness are complete.
- Partner with cross-functional teams and vendors to deliver a compliant, audit-ready facility on schedule.
- Bachelor's degree in Engineering or a related technical discipline.
- 15+ years supporting pharmaceutical or biopharmaceutical capital projects.
- 10+ years of commissioning, qualification, validation (CQV), startup, field engineering, or construction management experience in GMP facilities.
- Experience supporting laboratory, R&D, or biopharmaceutical manufacturing facilities.
- Strong knowledge of clean rooms, HVAC, clean utilities, process equipment, FAT/SAT, commissioning, IOQ, and facility turnover.
- Experience interpreting engineering drawings and coordinating construction activities.
Experience with vivarium facilities, Lean Construction, Last Planner System, Six Sigma, Bluebeam, AutoCAD, Revit, or SharePoint.
Location:Westchester County, NY (Onsite)
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