CQV Engineer (m/f/d)
- Execution of the following activities for the relevant systems in accordance with Project procedures/guidelines
- System Boundary development and approval
- Design Qualification preparation, execution and approval. Includes release for IQ
- GMP-RA’s
- Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality
- Installation Qualification preparation, execution and approval. Includes release for OQ
- Operational Qualification preparation, execution and approval. Includes release to OPS
- Provide support in execution of Design Qualification for other direct impact systems
- Provide support in the implementation of the Installation Commissioning process in accordance with Project procedures/guidelines
- Shall be able to work / support another C&Q activity if deemed necessary
- Minimum Bachelor’s degree in Life Sciences or Engineering
- Solid experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry
- Proven experience on performing qualification (IQ and OQ) on CIP skids
- Solid experience in commissioning / qualification / validation of Clean Utilities Systems
- Experience with DeltaV (Emerson)
- Fluent English language written and verbal communication skills
- CGMP knowledge and knowledge of regulatory requirements
- Able to work with minimum oversight fulfilling deliverables within target dates
- Preferred requirements: experience with Lonza Commissioning / Qualification Approach and COMOS / KNEAT Platforms
- Experience with COMOS/KNEAT platforms
- Further training oppurtunities
- Friendly working enviroment
À propos de l'entreprise