Role & responsibilities: -
Equipment Maintenance & Troubleshooting -
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 recent 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.
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