CSV Junior Engineer
Posted on May 14, 2022 by Actalent
An industry leader in pharmaceuticals is looking for a Junior CSV Engineer to assist in the Computer System Validation (CSV) activities for Technical Services department and start growing within an exciting role.
Assess and handle quality issues and corrections or CAPAS associated under the scope of CSV.
Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
Bachelor/master's degree in technical or natural sciences
A minimum of 1 year working experience within pharma or a biotech company
Initial experience on validating software & hardware infrastructure (e-g: Servers, network and software services).
Know-how of CSV requirements according to FDA 21CFR part 11/EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
For more information, feel free to reach out to (see below)
Job Title: CSV Junior Engineer
Location: Bern, Switzerland
Job Type: Contract
Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website.
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