Your Impact :
Jacobs are looking for CSV Engineer with CSV Strategy and Execution experience, to support ongoing project in Bern, Switzerland.
Primary resource for the development, execution, review, and approval of Computerized Systems Validations and generation of applicable documentation in support of the Computerized System Life Cycle in accordance with 21 CFR Part 11 and GAMP5.
This role will be hands-on and highly cross-functional working closely with various departments who work with GXP systems
Key role responsibilities :
Works cross functionally with System Owners, IT, and QA Representative for Equipment / Software Validations and provide expertise on equipment / software validations.
Collaborate with testing and manufacturing personnel, system vendors, IT, and QA to support new systems introduction for GXP use (including support with developing URS and FDS).
Write, execute, review, or approve Equipment and Software Validations (IQ, OQ, PQ); work with IT and applicable system vendors in creating test scripts as required.
Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents ICH, ISPE, GAMP, ISO, etc.).
Participate in quality and process improvement initiatives, and project teams.
Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Here's What You'll Need :
5 years of relevant experience
Bachelors’ degree in a Science related field, or equivalent experience
Knowledge of 21 CFR Part 11 and ISPE GAMP5 is required
Previous experience with large international projects
Having an eye for a detail