Consultant, Commissioning, Qualification & Startup Lead - Biopharma

GForce Life Sciences; New York (NY); On-site; USD 192,864 - 316,848; Full time

Job summary

GForce Life Sciences is seeking a Senior CQV Lead to support the construction and startup of a new biopharmaceutical R&D facility in Westchester County, NY. You will act as the Owner's Representative to ensure the facility, equipment, cleanrooms, utilities, and building systems are designed, installed, commissioned, qualified, and ready for day-one operations.

You will lead cross-functional teams to deliver a compliant, audit-ready facility on schedule, reviewing engineering designs,

Qualifications

• 15+ years in pharmaceutical/biopharmaceutical capital projects.
• 10+ years in CQV, startup, field engineering, or construction management in GMP facilities.
• Experience supporting laboratory, R&D, or biopharmaceutical manufacturing facilities.
• Knowledge of cleanrooms, HVAC, clean utilities, and facility turnover.
• Experience interpreting engineering drawings and coordinating construction activities.

Responsibilities

• Lead commissioning, qualification, and startup for a large biopharma capital project.
• Review designs and equipment packages for GMP compliance.
• Coordinate installation, startup, FAT/SAT, IOQ, and turnover activities.
• Resolve RFIs, NCRs, and field changes during construction.
• Ensure turnover docs, SOPs, training, maintenance plans, and operations readiness.
• Partner with cross-functional teams and vendors to deliver an audit-ready facility on schedule.

Skills

CQV experience

GMP knowledge

Project coordination

HVAC & clean utilities knowledge

Reading engineering drawings

Education

Bachelor's degree in Engineering

Tools

AutoCAD

Revit

Bluebeam

SharePoint

Lean Construction

Last Planner System

Six Sigma

Job description

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)