CQV Lead Utilities

CQV Lead Utilities

Location:

Netherlands
Contract Type:  Staff or Contract (12-month project)

Job Summary  We are seeking a CQV Lead – Utilities (Team Lead) to lead a team of engineers and specialists in the Commissioning, Qualification, and Validation (CQV) of critical utility systems within a GMP pharmaceutical environment. This role will be responsible for planning, coordinating, and overseeing CQV activities across clean and black utilities, ensuring successful delivery on time, on budget, and fully compliant with regulatory standards.

Key Responsibilities   Lead and manage a team of CQV engineers, contractors, and specialists in all commissioning and qualification activities.
Oversee CQV activities for clean and black utility systems (Purified Water (PW), WFI (Water for Injection), Clean Steam, Process Gases, HVAC systems, Cooling Towers).
Act as the CQV Subject Matter Expert (SME) for utilities throughout the project lifecycle.
Develop, execute, and approve commissioning and qualification documentation, including IQ/OQ (PQ where applicable).
Lead and support commissioning activities, ensuring systems are installed, tested, and operate as designed.
Review and approve URS, design specifications, risk assessments, and CQV deliverables.
Ensure compliance with EU GMP, FDA, ISPE Baseline Guides, and internal quality standards.
Coordinate CQV activities with Engineering, Quality, Automation, and Operations teams.
Monitor progress, resource allocation, and quality of CQV deliverables, ensuring timelines are met.
Support deviations, change controls, and impact assessments related to utilities.
Represent the utilities team during regulatory inspections and audits.
Key Requirements   Experience in pharmaceutical or biopharmaceutical environments with team leadership responsibility.
Strong hands‑on experience in Commissioning of utility systems (key requirement).
Proven CQV experience with clean and black utilities, including PW, WFI, clean steam, HVAC, process gases, and cooling towers.
Experience using Kneat (e‑validation system) — training will be provided if required.
Knowledge of GMP, ISPE Baseline Guides, and regulatory compliance requirements.
Excellent leadership, communication, and stakeholder management skills.
Ability to prioritize and manage multiple activities in a fast‑paced project environment.
Other Requirements   Must be able to commit to a minimum 40‑hour work week, with flexibility based on project needs.
This role is site based.
Eligible to work in the EU without the need for visa sponsorship, now or in the future.

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