Consultant, Commissioning, Qualification & Startup Lead - Biopharma

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, cleanrooms, 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.

What You'll Do

• 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.

Qualifications

• 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 cleanrooms, HVAC, clean utilities, process equipment, FAT/SAT, commissioning, IOQ, and facility turnover.
• Experience interpreting engineering drawings and coordinating construction activities.

Preferred: Experience with vivarium facilities, Lean Construction, Last Planner System, Six Sigma, Bluebeam, AutoCAD, Revit, or SharePoint.

Location: Westchester County, NY (Onsite)

Contract: 12+ months | Start ASAP