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/Bowie–Dick 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 (250–320°C), 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
Injectables–Specific 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
Experience: 3–5 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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