Description
We are looking for a
Computer System Validation Engineer (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Manage, co-ordinate and develop validation deliverables for a new IS project
- Support and co-ordinate qualification and validation processes
- Support activities include, but are not limited to the preparation of validation/qualification plans, risk assessments, user requirement specifications, traceability matrix, testing (IQ, OQ/PQ), data migration, SOPs and change controls
- Facilitate the release of the regulated system for GxP production use in line with project timelines
- Support the problem solving of project deviations/errors and provide quality guidance on GxP regulatory requirements (including, but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
- Participate in project teams as required
- Responsibility for defining test strategy, designing and developing test cases according to software requirements, architecture designs, and code of complex software systems
- Conduct validation training with project team, communicating deliverables, procedures and methods
Your qualifications
- Bachelor's degree in Automation Engineering, Electrical Engineering, Systems Engineering, Technology or a related discipline.
- Profound industry experience in software engineering
- Software validation and equipment validation experience in a regulated industry (FDA 21 CFR 820, the Quality System Regulation and ISO 13485)
- Experience in GxP computerised systems
- Understanding of GAMP5 guidelines
- Validation experience with ERP, CCMS/CMMS, and quality systems is preferred
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11
- Strong knowledge of computerized system development life cycle approach is required
Skills:
- Qualification/validation specialist