Clean Utilities SME
- Germany, Munich
- Contract
- Life Sciences
We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Munich. 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
- 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
#LI-JL1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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Jenny
I manage this role.