- Execute preventive, predictive, and breakdown maintenance on critical aseptic processing machinery.
- Troubleshoot and repair complex equipment including vial washing machines, depyrogenation tunnels, sterilizers, autoclaves, and lyophilizers.
- Maintain and calibrate critical utility systems such as HVAC, purified water (PW), Water for Injection (WFI), and clean steam systems.
- Perform root cause analysis (RCA) on recurring equipment failures and implement corrective and preventive actions (CAPA).
Compliance & Documentation -
- Strictly adhere to cGMP, Positive Documentation Practices (GDP), and internal Standard Operating Procedures (SOPs).
- Maintain accurate maintenance logs, equipment history files, and calibration records to pass internal and external regulatory audits.
- Support the execution of equipment qualifications (IQ/OQ/PQ) and validation activities for new and modified equipment.
Production & Team Support -
- Assist operations during product changeovers, line clearance, and equipment setup to ensure maximum uptime and Overall Equipment Effectiveness (OEE).
- Collaborate with cross-functional teams (Quality, Production, and Validation) to optimize machinery performance.
- Manage spare parts inventory to ensure critical components are always available without overstocking.
Preferred candidate profile: -
- Required Experience: - 7 to 13 years
- Required Educational Qualification - M. Tech. / M.E. / B. Tech. / B.E.