Qualification & Validation Specialist

Position: QUALIFICATION & VALIDATION SPECIALIST
Experteer Overview  In this role, you will lead qualification and validation activities within the Quality Unit to ensure GMP‑compliant equipment, processes, and systems. You will design and execute qualification plans, draft and verify VMPs and validation documents, and support calibration and maintenance activities. You will work cross‑functionally to drive continuous quality improvements and ensure robust validation of HVAC, water systems, and process gases.

This is a hands‑on position at a biotech company that values quality, compliance, and operational excellence.
Retribuzione / Benefits   Manage qualification plans and written procedures
Draft, verify and execute qualification protocols and tests (FAT, SAT, IOQ, PQ)
Perform validation test runs and related activities
Draft and monitor VMP activities
Support qualification activities for equipment and utilities (HVAC, water systems, process gases)
Support Maintenance with calibration and maintenance plans/instructions
Facilitate continuous improvement in quality-related matters
Responsabilità   Degree in Engineering, Chemistry, Biotechnology, Pharmaceutical Chemistry and Technology, or related field
3–4 years of pharmaceutical industry experience
Knowledge of GMP
FMEA, HACCP or other risk‑based methodologies
Knowledge of validation/calibration instruments and validation procedures (VMP, FAT/SAT, IQ, OQ, PQ)
Requisiti fondamentali   Salary package 35,000–45,000 EUR per year

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