Key Responsibilities:-
Lead entire manufacturing line during shift, covering filling, compounding, sterilization, and support areas- Drive execution of shift production plan, monitor OEE, yield, and critical KPIs- Ensure MES compliance: batch initiation, electronic logbook completion, exception handling, and e records accuracy- Approve batch steps electronically in MES where authorization hierarchy allows- Coordinate with QA, Engineering, Warehouse, and Utilities for seamless shift functioning- Perform real time troubleshooting, lead deviation triage, ensure documentation of events- Ensure equipment qualification/validation readiness and support PQ/verification activities- Lead shift review meetings, manpower allocation, and adherence to safety and gowning discipline- Ensure data integrity compliance across MES, SCADA, BMS and paper records
Technical / Functional Skills:- Strong hands on experience with MES (Manufacturing Execution System) operations- Expertise in qualification & validation (IQ/OQ/PQ, media fill, SIP validation, filtration validation)- Understanding of isolator/RABS filling lines, compounding vessels, and sterilization equipment- Knowledge of SCADA/BMS/MES interfaces and troubleshooting- Strong command of cGMP, Annex 1, and data integrity principles (ALCOA+)
Behavioral Competencies:- Strong leadership and decision making under pressure- Excellent communication and cross functional collaboration- High sense of ownership, discipline, and integrity
Injectables–Specific Expectations:- Experience leading full shift manufacturing operations in sterile injectables- Ability to oversee qualification, validation, and readiness of all unit operations- Proficiency in MES–based batch execution and exception handling
Education:
Experience:
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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