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CQV Engineer

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
07-05-2024
30339
CQV Engineer – Pharmaceuticals – Contract – Denmark

Our client, a global organisation in pharmaceutical manufacturing, is recruiting for a CQV Engineer to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.

As the CQV Engineer, you will be responsible for overseeing the CQV activities across the utilities on a complex drug manufacturing extension project.


CQV Engineer Responsibilities:
  • Support the commissioning, qualification and validation of all supporting systems for a new lab build
  • The initial phase of the lab program will house predominantly fridges, freezers and TCU’s – then phasing out to a further building with more autoclaves and washers.
  • Review vendor documents to support commissioning and qualification requirements.
  • Completes the development, review, and execution of validation plans.
  • Ensure validation non-conformances or deviations are minimised during execution of CQV activities.
  • Supervise vendors/ contractors on site during commissioning activities.
  • Ensure compliance with current industry regulations and guidelines relating to validation.
  • Support department performance against defined KPIs.
  • Participate fully in cross-functional training initiatives.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the Project Manager or CQV Lead.

About you:
  • 5 + years’ commissioning, qualification, and validation (CQV) experience within a complex project environment.
  • Extensive understanding and knowledge of supporting systems including but not limited to fridges, freezers, temperature-controlled units, autoclaves and parts washers.
  • Previous work as part of a matrix organisation to deliver start-up projects.
  • Knowledge of validation practices and regulatory guidelines for a biopharma / pharmaceutical facility.
  • Experience with regulatory audits, in particular representing equipment qualification type issues.
  • Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting.

Does this CQV Engineer sound like a great opportunity for you? Get in touch with us to make your application!

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