We have a current opportunity with our Pharmaceutical client for a CSV Engineer on a contract basis till the end of the year (possible extension). The position will be based in Bern.
CSV Engineer:
- In charge of Computer System Validation (CSV) activities
- Ensure that Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Ensure Validation Master plans are up to date and established for all ongoing projects
- Assess and lead the CSV package(s) on an assigned project.
- 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, Validation Reports.
- Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
Requirements
- Experience on validating computerized manufacturing equipment (CSV context)
- Experience on validating software & hardware infrastructure (e-g: servers, network and software services).
- A minimum of 4 years of working experience with CSV
- Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
For further information about this position please apply directly via the link.
