Bachelor's degree in a scientific or engineering discipline with a minimum of six (6) years of experience, or a Master's degree with a minimum of four (4) years of experience, within the biological and/or pharmaceutical industry.
QA or validation experience on C&Q; projects for sterile/aseptic drug product manufacturing equipment (e.g., fill-finish of parenteral products).
Hands-on experience with the qualification/validation lifecycle (URS, CARA, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation, including reviewing and approving protocols and reports.
Strong understanding of cGMP (21 CFR 210/211 and 600s), and FDA, EMA and ICH guidelines (including ICH Q9(R1) and Q10)
Working knowledge of EU GMP Annex 1 (2022), including the Contamination Control Strategy, EU GMP Annex 15, and the FDA 2004 Guidance for Sterile Drug Products Produced by Aseptic Processing.
Familiarity with industry standards and guidance for risk-based C&Q; and validation lifecycle principles, including ASTM E2500 and the ISPE Baseline Guide Vol. 5 (2nd Ed.) and GAMP 5 (2nd Ed.).
Working knowledge of computerized system validation (CSV/CSA), 21 CFR Part 11, EU Annex 11 and data integrity (ALCOA+) principles.
Strong understanding of risk-based approaches to commissioning and qualification/validation, with proficiency in risk management methodologies such as FMEA, HACCP, HAZOP and ICH Q9(R1) quality risk management.
Proficiency in technical writing for validation and quality documents.