Job Description

To lead and manage utility systems in a API manufacturing facility & Drug product -Bottle filling & packing line equipment's. The candidate should have strong experience in pharmaceutical utility operations, maintenance, high standards of safety and regulatory compliance.


Oversee the operation and maintenance of all utility systems Brine chillers, Air compressors, HVAC, N2 plant, Air dryer Chilled water chillers, etc. Ensure 24x7 availability of utilities for uninterrupted manufacturing. Plan and implement preventive and breakdown maintenance schedules. Ensure all utility operations comply with cGMP, USFDA, and other regulatory standards. Lead utility qualifications (IQ/OQ/PQ) and support audits and inspections. Coordinate with engineering, production, and QA/QC for smooth plant operations. Manage energy efficiency, safety, and sustainability initiatives. Guide and train the utility team for skill development and compliance

Maintenance & Troubleshooting:

Perform troubleshooting of instruments and equipment. Responsible for breakdown maintenance and preparation of breakdown analysis reports. Monitor and reduce the equipment breakdowns through close observation and analysis. Ensure preventive and proactive maintenance to avoid equipment failure. Maintain spares for critical instruments to ensure smooth plant operations.

Documentation & Reporting:

Prepare and review SOPs, daily/monthly reports, and handle deviations and change control forms (CCFs). Generate SAP indents and consumption reports as per site requirements. Support GMP Pro software system documentation and tasks.

CSV and Qualification Activities:

Handle CSV-related documentation for water systems and process equipment. Review qualification documents for utilities and process equipment. Participate in qualification and commissioning activities of new systems and equipment.

Material Handling & SAP:

Responsible for PRN initiation, material indenting, and stock monitoring in SAP. Crosscheck incoming materials without POs to ensure accuracy and quality.

Team Supervision & Coordination:

Oversee engineering team operations in individual API/Pharma blocks. Allocate work orders, monitor progress, and ensure timely completion. Assist the Engineering Manager with day-to-day responsibilities.

Safety & Compliance:

Follow safety permit procedures including Hot Work, Vessel Entry, Work at Height, and Excavation permits. Ensure 100% equipment availability through structured preventive maintenance. * Implement corrective and preventive actions (CAPA) within defined timelines.