Job Description
Job Description
Key Responsibilities:-
Supervise autoclave sterilization cycles for components, equipment parts, and solutions as applicable- Plan and monitor load patterns, cycle parameters, and F0; perform pre-run leak test/BowieDick where applicable- Oversee component preparation systems: parts washer, vial washer, depyrogenation tunnel, stopper processor- Ensure component cleanliness, dryness, and bioburden/endotoxin control prior to sterilization- Coordinate routine maintenance/calibration for sensors, recorders, and safety interlocks- Review sterilization records, charts, and batch documentation; ensure ALCOA-compliant data- Support qualification (IQ/OQ/PQ), temperature mapping, and periodic requalification activities- Handle deviations, investigations, CAPA, and change controls related to sterilization and component prep- Train operators on correct loading, wrapping, sealing, and post-sterilization handling- Drive improvements in cycle robustness, throughput, and component preparation right-first-time
Technical / Functional Skills:- In-depth knowledge of moist heat sterilization, F0 calculation, SAL concepts, and load configuration- Experience with parts washers, vial washers, depyrogenation tunnels (250320C), and stopper processors- Understanding of steam quality (dryness fraction, non-condensable gases) and vacuum leak tests- Knowledge of BI/CI usage, placement, and acceptance criteria; temperature mapping and data loggers- Familiarity with component preparation for aseptic lines (siliconization, tray alignment, transfer)- cGMP, Annex 1, US FDA expectations, and data integrity (ALCOA+) mastery
Behavioral Competencies:- Ownership, discipline, and a strong compliance mindset- Ethical behavior, honesty, and accuracy in documentation- Clear communication and cross-functional coordination- Ability to coach operators/technicians and manage shifts- Structured problem-solving and calm decision-making on the floor
InjectablesSpecific Expectations:- Demonstrated success managing autoclaves and component preparation end-to-end- Awareness of endotoxin control and depyrogenation validation for glassware- Ability to support audit queries and present sterilization evidence confidently
Qualifications
Experience: 35 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm
