CQV Engineer
Randstad (Switzerland) Ltd.
Publication date:
05 March 2025Workload:
100%- Place of work:Basel
Job summary
Join a leading pharma/biotech company in Berne as a CQV Engineer. Enjoy a dynamic work environment with a one-year limited contract opportunity.
Tasks
- Oversee commissioning and qualification processes to meet deadlines.
- Prepare and execute Design Qualification, ensuring compliance.
- Manage vendor activities to ensure quality of testing and scope.
Skills
- Diploma in Life Sciences or Engineering with 4+ years of relevant experience.
- Fluent in English and German with strong cGMP knowledge.
- Ability to assess project risks and implement mitigation strategies.
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job details
For our client in Berne we are looking for a CQV Engineer for a pharma/biotech company:
Location: Berne
Contract: limited contract
Duration: 1 year
The CQV Engineer is responsible for planning and executing Commissioning & Qualification (C&Q) activities to ensure project milestones are met. Key responsibilities include:
- Overseeing commissioning and qualification processes to meet project deadlines.
- Preparing, executing, and obtaining approval for Design Qualification (DQ), including release for Installation Qualification (IQ).
- Managing commissioning activities, including vendor supervision to ensure testing quality and scope compliance.
- Preparing, executing, and approving Installation & Operational Qualification (IQ/OQ), ensuring release for Operational Qualification (OPS).
- Supporting the execution of Design Qualification for other critical systems.
- Maintaining oversight of activities and schedules related to relevant systems.
- Actively contributing to the development and delivery of project deliverables.
- Reporting on key deliverables and aligning tasks with project milestones.
- Identifying and assisting in resolving project issues, including tracking non-conformance records.
- Assessing project risks and evaluating the effectiveness of mitigation strategies.
- You hold a diploma in Life Sciences or Engineering, or similar
- You have 4 years minimum of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech environment
- You have a good knowledge of cGMP and regulatory requirements
- You are fluent in English & German
