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Clean Utilities SME

  1. Germany, Frankfurt
Frankfurt ( Oder)
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37484
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Clean Utilities SME - 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 Clean Utilities SME to join their team.

Responsibilities include:
  • Serve as subject matter expert (SME) for clean utilities including WFI, PW, clean steam, and process gases (sterile)
  • Oversee design, installation, and CQV of clean utility systems in compliance with GMP and Annex 1
  • Collaborate with engineering, CQV, and operations teams to ensure system readiness and compliance
  • Support risk assessments, deviation resolution, and change control processes
  • Ensure clean utility systems meet sterility, reliability, and performance requirements
  • Review and approve technical documentation including URS, DQ, IQ/OQ, and SOPs
  • Provide technical leadership during FAT/SAT and validation phases
  • Contribute to training and knowledge transfer for operational teams
Key requirements include:
  • Requires extensive experience in clean utilities within sterile pharmaceutical manufacturing
  • Deep knowledge of GMP, EU Annex 1, and clean utility system design and operation
  • Proven experience in greenfield project execution and CQV lifecycle
  • Strong cross-functional collaboration and documentation skills
  • Fluent in English; German is advantageous
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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