Senior Technical Assistant Job in CPL Pharmaceuticals Private Limited at Udaipur

Major Purpose of the Job : Responsible for Preventive and breakdown maintenance of all critical process equipment and systems, including the lyophilized vial filling line, and other plant machinery, with a focus on mechanical maintenance, troubleshooting, and equipment reliability. The person should have working experience on specific machines in the injection plant, such as the vial filling line, lyophilizer, manufacturing vessels, autoclaves, automatic visual inspection machines, automatic leak-test machines, automatic labeling machines, automatic cartoners, stability chambers, cold rooms, and other associated process equipment etc. Principal task and responsibilities: Ensure compliance with cGMP requirements, Good Engineering Practices (GEP), and all applicable statutory laws, rules, and regulations Responsible for preventive, predictive, and breakdown maintenance of critical process equipment in the injection plant, including vial filling lines, lyophilizers, manufacturing vessels, autoclaves, and associated machinery. Perform troubleshooting, fault diagnosis, and root-cause analysis of mechanical issues to minimize equipment downtime and ensure continuous production. Execute planned preventive maintenance activities as per approved schedules, OEM recommendations, SOPs, and equipment maintenance requirements. Maintain and troubleshoot lyophilized vial filling lines, including mechanical components, filling mechanisms, conveyor systems, pumps, drives, and other associated assemblies. Carry out mechanical maintenance of lyophilizers, manufacturing vessels, autoclaves, automatic visual inspection machines, leak-test machines, labeling machines, and cartoners. Ensure reliable operation of stability chambers, cold rooms, and other temperature-controlled/process equipment, including routine inspection and mechanical maintenance. Perform mechanical activities such as bearing and seal replacement, lubrication, alignment, belt/chain replacement, pump maintenance, valve servicing, gearbox maintenance, and equipment overhauling. Coordinate with Production, Engineering, Electrical, Instrumentation, QA, and other cross-functional teams for planned maintenance, breakdown resolution, and equipment qualification-related activities. Maintain accurate equipment history cards, PM checklists, breakdown reports, maintenance logs, spare-parts records, and documentation in compliance with GMP requirements. Ensure compliance with GMP, EHS, SOPs, LOTO, permit-to-work, and other applicable safety and regulatory requirements, while driving continuous improvement in equipment reliability, OEE, and maintenance efficiency. Ensure availability of critical spares and intimate concerned personnel well in advance to enable timely procurement. Ensure effective implementation and compliance of cGMP practices within the plant. Maintain and promote safety practices during plant operation and maintenance activities.