Job Description
Key Responsibilities Ensure trouble-free operation and maintenance of process and utility equipment. Plan and monitor preventive maintenance activities to minimize downtime. Handle equipment breakdowns, RCA, and CAPA implementation. Lead equipment qualification, validation, calibration, and requalification activities. Review SOPs, protocols, reports, technical documents, and validation records. Manage engineering compliance with cGMP and regulatory requirements. Coordinate with cross-functional teams for projects, modifications, and engineering support. Monitor spare inventory and ensure availability of critical spares. Ensure adherence to EHS requirements and work permit systems. Prepare technical evaluations, cost estimates, and techno-commercial comparisons for projects. Technical Requirements Hands-on experience in sterile manufacturing and filling equipment. Good understanding of aseptic practices, cleanroom behavior, and GMP documentation. Ability to independently manage shop-flo...