Clean Utilities SME - Switzerland, Bern - 18 Month Contract
We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Bern. Due to a large capital investment and multiple projects on site, the client is looking for aClean 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 toBernand interested in discussing this position, please submit your profile and we will be in contact at our earliest convenience.
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