- York, Pennsylvania, United States
- 3–5 years
Support validation and qualification activities in GMP pharmaceutical/biotechnology manufacturing environments.
Responsibilities
- Author and execute IQ/OQ/PQ protocols, validation plans, and summary reports
- Support qualification and requalification of GMP facilities, utilities, manufacturing equipment, and cleanrooms
- Support airflow visualization/smoke studies in aseptic environments
- Perform autoclave qualification including temperature mapping, heat penetration, leak testing, Bowie-Dick testing, biological indicators, and load qualification
- Analyze validation and thermal mapping data and identify appropriate worst-case locations
Requirements
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related technical discipline
- Nice to have: Airflow visualization/smoke studies in aseptic or ISO-classified environments
- Nice to have: Steam sterilization/autoclave qualification and temperature mapping
- Nice to have: Experience with thermocouples, biological indicators, Kaye, or similar validation systems
- Nice to have: Cleanroom qualification and ISO 14644 experience