Project Commissioning; CQV) Manager - Life Sciences

Project Commissioning (CQV) Manager
- Life Sciences

Project Commissioning (CQV) Manager
- Pharmaceutical / Life Sciences
Illinois, USA | Site-Based | Permanent

We are supporting the appointment of a Project Commissioning (CQV) Manager for a major pharmaceutical capital project in Illinois.

This is a senior, site-based leadership position for an experienced commissioning professional who can take overall responsibility for the commissioning and CQV function on a complex EPC project, from early project planning through construction, startup, qualification and final handover.

This is not purely a validation role. We are looking for someone who combines strong hands‑on commissioning leadership, pharmaceutical/CQV knowledge and major construction project experience.

You will establish and lead the project commissioning organisation and oversee commissioning activities throughout:

• Developing the overall Commissioning Execution Plan, strategy and methodology
• Establishing commissioning philosophies, procedures and technical documentation
• Integrating commissioning activities and milestones into the overall project schedule
• Leading commissioning planning, scheduling and resource requirements
• Coordinating Engineering, Procurement, Construction, Quality/CQV and HSE teams
• Managing commissioning contractors, subcontractors and equipment vendors
• Leading commissioning readiness reviews and system turnover activities
• Overseeing Mechanical Completion, Systems Completion, pre-commissioning and startup
• Managing functional testing, system acceptance and operational readiness
• Supporting pharmaceutical CQV and GMP requirements
• Managing client interfaces and commissioning‑related stakeholder relationships
• Monitoring commissioning KPIs, progress, risk, cost and schedule
• Leading final turnover, handover and project closeout
• Building, coaching and leading a multidisciplinary commissioning team

Candidates should ideally have:

• 10+ years of Commissioning / CQV Management experience within complex capital projects
• Significant Pharmaceutical / Biopharma / Life Sciences project experience
• Strong understanding of GMP/cGMP and CQV environments
• Experience leading commissioning on major EPC, EPCM, General Contractor or design‑build projects
• Multidisciplinary commissioning experience covering Mechanical, Electrical and Process systems
• Demonstrable responsibility for commissioning teams, contractors and vendors
• Experience taking systems from construction completion through startup and handover
• Strong commissioning planning, scheduling and documentation experience
• Bachelor's or Master's degree in Mechanical, Electrical, Chemical Engineering or equivalent relevant experience

Relevant technical experience may include:

HVAC | Clean Utilities | WFI | Purified Water | Clean Steam | Compressed Air | Process Piping | Process Skids | CIP/SIP | Clean rooms | Pharmaceutical Manufacturing Equipment | MV/LV | UPS | Generators | BMS/BAS | EMS | PLC/DCS/SCADA | Instrumentation & Controls

Experience with FAT/SAT, IQ/OQ/PQ, risk‑based qualification, ASTM E2500, ISPE and/or GAMP would be particularly relevant.

The strongest candidates will be people who can operate at both levels: develop the commissioning strategy and organisation at leadership level while remaining close enough to site execution to drive construction turnover, startup, qualification and handover.

This is a full‑time site‑based position in Illinois, so candidates must be willing and able to work on site for the duration of the assignment.