Validation Engineer m/w/f
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Aubonne, Switzerland |
Temporary Employment
Project title: Validation Engineer m/w/f
Type of employment: Payroll
Industry: Biotech
Skills: validation engineer
Project start: 01.11.2025
Project duration: 6 months
Location: Aubonne, Switzerland
You will be responsible for the qualification and validation of automated and computerized equipment and systems in a pharmaceutical environment, ensuring compliance with regulatory standards (cGMP, GAMP, 21 CFR Part 11). You will contribute to complex, multidisciplinary projects in close collaboration with cross-functional teams and external service providers.
Tasks:
- Represent the department in project kick-off and follow-up meetings.
- Prepare, update, and archive qualification/validation documentation:
- Qualification/Validation Plans (QP/VP)
- Protocols and Reports (DQ, FAT, SAT, IQ, OQ, PQ/VAT)
- Traceability Matrices (TM)
- Schedule, organize, and execute qualification/validation tests.
- Coordinate external service providers involved in initial qualifications/validations.
Qualifications:
- Proven experience in qualification/validation within the pharmaceutical industry.
- Expertise in CSV & Data Integrity validation (21 CFR Part 11, GAMP).
- Familiarity with equipment such as filling lines, packaging systems, Track & Trace, and biotech platforms.
- Experience with global IT/OT systems validation: Global Data Historian, cybersecurity, GLIMS release, Trackwise.
- Equipment qualification following the V-cycle: utilities, packaging, chromatography columns.
- Strong knowledge of pharmaceutical industry practices related to qualification/validation under cGMP.
- Proficiency in risk analysis tools (FMECA, APR, FMEA) and continuous improvement methodologies (Lean, Six Sigma).
- Comfortable with office tools, spreadsheets, Mango (or equivalent systems), Trackwise
- Engineering degree or equivalent with confirmed experience in automated/computerized equipment qualification and CSV in a pharmaceutical setting.
- Fluent in French.
- Professional proficiency in spoken and written English.
Referenznummer: 16682
Branche: Biotech
Beginn des Projekts: 01.11.2025
Dauer: 6 months
Anstellungsart: Temporary Employment
Kontakt
Tünde Verebélyi