Degree in Engineering, Pharmaceutical Sciences, Biotechnology, or Life Sciences
Min. 5 years of validation experience in pharma, biopharma, or other regulated industries
Hands-on experience with FUE, CSV, process, cleaning, and sterilization/disinfection validation
Strong knowledge of GMP and global regulatory guidelines (FDA, EMA, ICH, ISPE, ISO, PDA)
Able to prepare and review VMPs, IQ/OQ/PQ protocols, risk assessments (FMEA, HACCP), and traceability matrices
Experience with change control, CAPA, deviation management, and supporting regulatory inspections