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.

The Role

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

Preconstruction → Engineering → Procurement → Construction → Mechanical Completion → Pre-Commissioning → Startup → CQV → Turnover & Handover

Key responsibilities will include:

* 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

What We're Looking For

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 | Cleanrooms | 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.

Who This Will Suit

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.

TEC Group International is acting as an Employment Agency in relation to this vacancy.