CQV Engineer

X4 Life Sciences
Durham
4 days ago
Applications closed

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CQV Quality Assurance Specialist

Job Title:CQV Engineer – Clean Utilities

Location:North East England

Job Type:Contract (Outside IR35)

Industry:Biopharmaceutical / Pharmaceutical Manufacturing


We are seeking an experienced CQV Engineer with specialized expertise in

Clean Utilities to support a pharmaceutical project for a long term contract. The Engineer will be working on the following systems: Purified Water, Clean Steam, Process Gases (e.g., Nitrogen, Compressed Air) and WFI. Experience with WFIsystems is considered a strong advantage, but not a strict requirement.


Key Responsibilities:


  • Develop and execute CQV lifecycle documentation (DQ, IQ, OQ, PQ) for clean utility systems
  • Oversee and support commissioning activities, including loop checks, functional testing, FAT/SAT execution, and field verification.
  • Review engineering and design documents (P&IDs, URS, equipment datasheets) to ensure alignment with regulatory and operational requirements.
  • Coordinate with vendors, contractors, and internal teams to facilitate the timely and compliant delivery of clean utility systems.
  • Perform risk assessments and define validation strategies based on system impact and criticality.
  • Manage and resolve deviations, discrepancies, and change controls related to clean utility equipment and processes.
  • Ensure all documentation is accurate, complete, and audit-ready.


This is an initial 12 month contract, but the project scope is for 2-3 years, so the role offers excellent longevity.


If you are interested and would like to find out more, please apply directly, or reach me at .

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