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Senior Lifescience Consultant with a strong industrial background
Job Description Summary:
The CQV Engineer is primarily responsible for the preparation of documentation in compliance with cGMP and all internal standards pertaining to their specific project and the execution of the CQV activities corresponding to their project’s area and equipment.
Key Accountabilities:
* Activities for the relevant systems in accordance with Project procedures/guidelines.
* System Boundary development/ 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
* Knowledge of PSSR write ups and system checks
* Knowledge of HVAC and Utility systems
* Carry out shift work, where required
* Knowledge of Interface Management
* University degree in Life Sciences or Engineering
* At least 4+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
* At least 4+ years of experience in commissioning / qualification / validation of Clean Utilities Systems.
* Experience with DeltaV (Emerson) and other Control Systems
* Fluent English language written and verbal communication skills, fluent German skills are a big plus
* cGMP knowledge and knowledge of regulatory requirements.
* Willing to work on site in Visp
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance, Production, and Research
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