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CQV Lead

  1. Germany, Frankfurt
Frankfurt ( Oder)
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
37550
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CQV Lead - Germany, Frankfurt - 18 Month Contract 

We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Frankfurt. Due to a large capital investment and multiple projects on site, the client is looking for a CQV Lead – Isolators and vision systems to join their team.

Responsibilities include:
  • Lead the VPHP cycle development and qualification of Skan and Syntegon Isolator.
  • Collaborate with cross-functional teams (Engineering, QA, Automation) to develop and review URS,
  • FDS, and high-level specifications.
  • Over see third party qualification of Visual inspection equipment.
  • Manage the qualification lifecycle of Isolators and Vision equipment (FAT/SAT, IQ, OQ, PQ).
  • Perform troubleshooting, deviation investigations, and corrective actions related to sterilisation or
  • utility validation processes.
  • Support GMP documentation processes, including protocol authoring, execution, and final
  • reporting.
Key requirements include:
  • Degree in Engineering, Life Sciences, or a related technical field.
  • Requires extensive experience in validation/CQV  in the pharmaceutical or biotech industry.
  • Proven experience with VPHP cycle development, isolator qualification.
  • Familiarity with cleanroom environments, containment systems, and GMP compliance.
  • Strong understanding of commissioning documentation and qualification protocols (IQ/OQ/PQ).
  • Excellent communication skills and ability to work cross-functionally in a regulated environment.
  • Experience using Kneat.

If you are local to Frankfurt and interested in discussing this position, please submit your profile and we will be in contact at our earliest convenience.

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