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Validation Engineer m/w/f (DE)
[16682]
validation engineer
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.
- 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.
- 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.
Tünde Verebélyi