Major Purpose of the Job : Responsible for Preventive and breakdown maintenance of critical process equipment, including the lyophilized vial filling line, manufacturing vessels, autoclaves, automatic visual inspection machines, automatic leak-test machines, automatic labeling machines, automatic cartonator , stability chambers, cold rooms, and other associated process equipments. The person should have working experience on specific automated machines in the injection plant, such as the vial filling line, lyophilizer, Fedegari autoclave, Brevity inspection machine, Bonfiglioli leak-test machine etc. Principal task and responsibilities: Plan and execute preventive and corrective maintenance to ensure equipment reliability and minimize downtime through SAP. Develop and maintain calibration schedules; ensure timely execution, accurate documentation, and corrective actions when required. Maintain accurate maintenance and calibration records in compliance with GDP/GMP standards, ensuring SOPs are current and audit-ready. Ensure compliance with regulatory standards, including USFDA, EU-GMP, WHO, and local guidelines. Support equipment qualification (IQ/OQ/PQ) and provide maintenance data for validation activities. Oversee plant utilities, including HVAC, WFI, purified water systems, and compressed gases. Ensure availability and inventory control of critical spare parts and maintenance tools, maintaining optimal stock levels. Enforce safety protocols, including Lockout/Tag out (LOTO), and actively support EHS programs. Operate and maintain electrical infrastructure, including electrical substations, LT/HT breakers, sub panels, and DG sets. Conduct and attend training on equipment operation, SOPs, and safety practices to maintain operational competency. Participate in Root Cause Analysis (RCA) for recurring failures and support new installations, upgrades, and technology transfers. Complete tasks within deadlines assigned by senior management, ensuring efficient execution and timely closure.
