Senior CQV Engineer
Role Overview
We are looking for a Senior CQV Engineer for a duration of 12 months, to support pharmaceutical manufacturing projects, with primary responsibility for commissioning and qualification of GMP manufacturing equipment. The role requires a hands-on engineering profile capable of independently driving CQV activities from planning and protocol preparation through execution, documentation and handover.
Key Responsibilities
- Lead and coordinate Commissioning & Qualification activities for GMP manufacturing equipment, from commissioning through FAT, SAT, IQ, OQ and PQ.
- Develop, review and execute CQV protocols, test plans, qualification reports and associated technical documentation.
- Provide hands-on technical support during equipment installation, commissioning, start-up and qualification, including troubleshooting and resolution of technical issues.
- Coordinate CQV activities with Engineering, Project Management, Production, equipment suppliers and QA, ensuring milestones and GMP requirements are met.
- Manage qualification documentation, deviations, punch items and technical follow-up through to successful system handover.
Requirements
- Minimum 10 years of Commissioning & Qualification experience, ideally within pharmaceutical or biotech manufacturing.
- Extensive hands-on experience with GMP manufacturing/process equipment.
- Strong practical knowledge of FAT, SAT, IQ, OQ and PQ, including protocol writing and execution.
- Strong engineering and technical background, rather than a profile focused primarily on QA/document review.
- Demonstrated ability to independently manage CQV work packages and coordinate multiple technical stakeholders.
- Solid understanding of GMP requirements and qualification lifecycle principles.
- Fluent German and English are mandatory, both written and spoken.
- Strong communication, coordination and problem-solving skills.
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