Maintenance engineer / utility engineer

Job Description:

Key Responsibilities:

1. 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.

2. 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.

3. 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.

4. 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.