Key Responsibilities:
Equipment & Facility Maintenance:
Perform preventive, corrective, and predictive maintenance on manufacturing equipment and utilities.
Maintain and update maintenance logs using CMMS (e.g., SAP PM, Maximo).
Support qualification and validation activities (IQ/OQ/PQ) for equipment and systems.
Utility System Management:
Operate and maintain utilities such as HVAC, AHUs, Boilers, Chillers, WFI, Purified Water systems, Compressors, and ETP/STP.
Ensure clean utility systems comply with cGMP and GEP standards.
Monitor critical parameters and environmental conditions in production and cleanroom areas.
Compliance & Documentation:
Ensure all maintenance activities comply with cGMP, GEP, and safety regulations.
Maintain records and support documentation for audits and inspections (USFDA, MHRA, WHO, etc.).
Implement and maintain maintenance SOPs in line with regulatory expectations.
Troubleshooting & Continuous Improvement:
Perform root cause analysis (RCA) for breakdowns and implement CAPAs.
Participate in cross-functional improvement projects (e.g., energy saving, reliability enhancement).
Assist in equipment installation, commissioning, and optimization projects.