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- To assess and lead the CSV package.
- Plan, coordinate and execute all phases for computer system validation for production and QC lab systems.
- Perform CSV reviews of equipment and systems.
- Prepare, review and approve technical and GMP related documentation.
- Significant experience in CSV in the pharmaceutical or medical industries.
- Experience validating software and hardware infrastructure (servers, network and software services.
- Expert knowledge of CSV requirements according to FDA 21 CFR Part 11 / EU GMP Annex 11.
- Fluency in English and ideally German.
CSV Engineer - Bern, Schweiz - CK Science
Beschreibung
CSV Engineer
CK Group are recruiting for a CSV engineer to join a pharmaceutical company in Bern on a contract basis for a period of circa 8 months.
The Company:
Our client is a global leader in pharmaceutical and vaccine manufacturing.
Salary:
CHF per hour
Location:
This role is located at our client's site in Bern. This is a hybrid position and will require the worker to come to site at least 3 days per week, but may require extra days as needed.
CSV Engineer Role:
Your main duties will be:
Your Background:
The ideal candidate for this role will have