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CQV Engineer (Commissioning, Qualification, Validation)
Key Responsibilities and Tasks
- Coordinate equipment installation and draft validation protocols (IQ, OQ, PQ).
- Execute and document IQ/OQ/PQ in compliance with cGMP standards.
- Develop and manage validation documentation: URS, DQ, FMEA, Risk Assessments, FAT, SAT.
- Conduct and document validation for facilities, systems, and utilities throughout the validation life cycle.
- Perform GAP analyses and risk assessments; apply lessons learned to improve validation processes.
- Execute Quality Systems activities: document management, change control, non-conformities, and CAPA.
- Draft and revise procedures related to engineering validation and support requalification and maintenance programs.
Requirements
- Bachelor’s degree in a scientific or technical discipline.
- 5–10 years of experience in the pharmaceutical industry at an advanced level.
- Fluency in both German and English (written and spoken).
Skills
- Strong technical writing ability for accurate and timely documentation.
- Effective written and verbal communication across departments.
- Proficient in organizing and managing time across multiple tasks.
Please apply directly online with your CV.
**Please only apply if you are eligible to work in Switzerland and the EU*
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