Project Commissioning (CQV) Manager - Life Sciences

Tec Group International

Illinois

On-site

USD 140,000 - 200,000

Full time

12 days ago

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Job summary

Tec Group International is seeking a senior Project Commissioning (CQV) Manager for a major pharmaceutical capital project in Illinois. You will establish and lead the commissioning organisation, directing activities from planning through startup, qualification and turnover.

The role requires hands-on leadership of a site-based team across Mechanical, Electrical and Process systems within GMP environments. You will coordinate with Engineering, Procurement, Construction, Quality/CQV and HSE

Qualifications

  • 10+ years in Commissioning / CQV on complex capital projects.
  • Pharma/Biopharma/Life Sciences project experience.
  • Strong GMP/cGMP and CQV knowledge.
  • Experience leading commissioning on EPC/EPCM or design-build projects.
  • Experience managing commissioning teams, contractors and vendors.

Responsibilities

  • Develop the Commissioning Execution Plan, strategy and methodology.
  • Establish commissioning philosophies, procedures and documentation.
  • Integrate commissioning milestones into the project schedule.
  • Lead commissioning planning, scheduling and resource management.
  • Coordinate Engineering, Procurement, Construction, Quality/CQV and HSE teams.
  • Manage commissioning contractors, subcontractors and equipment vendors.
  • Lead commissioning readiness reviews and system turnover activities.
  • Oversee Mechanical Completion, Systems Completion, pre‑commissioning and startup.
  • Manage functional testing, system acceptance and operating readiness.
  • Support pharmaceutical CQV and GMP requirements.
  • Manage client interfaces and commissioning‑related stakeholder relationships.
  • Monitor KPIs, progress, risk, cost and schedule.
  • Lead final turnover, handover and project closeout.
  • Build, coach and lead a multidisciplinary commissioning team.

Skills

CQV Management
Pharma/Life Sciences
GMP / cGMP
EPC/EPCM project experience
Mechanical, Electrical, and Process

Education

Bachelor’s or Master’s in Mechanical/ Electrical/ Chemical Engineering

Job description

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:

  • 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.

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