Jobdescription
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.
Qualifications: 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