About this role
Plan and execute preventive, predictive, and breakdown maintenance activities.
Ensure maximum equipment availability and minimize production downtime.
Troubleshoot mechanical, electrical, and utility-related failures.
Maintain maintenance records, equipment history, and breakdown reports.
Ensure smooth operation of HVAC systems, AHUs, chillers, boilers, cooling towers, compressors, and other plant utilities.
Monitor purified water (PW), water for injection (WFI), and purified water generation/distribution systems, where applicable.
Monitor cleanroom pressure differentials, temperature, relative humidity, and other specified environmental parameters.
Ensure timely servicing, calibration, and maintenance of utility equipment.
Ensure compliance with applicable cGMP, SOPs, safety requirements, and regulatory standards.
Prepare and review engineering SOPs, preventive maintenance records, and equipment logbooks.
Coordinate equipment qualification activities, including IQ, OQ, and PQ, with QA and validation teams.
Handle deviations, change controls, CAPA, and audit observations related to engineering.
Maintain engineering documentation and support regulatory inspections and internal audits.
Coordinate installation, commissioning, qualification, and validation of new equipment and utilities.
Support engineering CAPEX projects, equipment upgrades, and facility modifications.
Coordinate with vendors, contractors, consultants, and cross-functional teams.
Ensure timely completion of projects within approved budgets and safety requirements.