Validation Engineer m/w/f

Type of employment: Payroll

Industry: Biotech

Skills: validation engineer

Project start: 01.11.2025

Project duration: 6 months

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.