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Job Summary
The Maintenance Engineer ensures reliable operation and upkeep of all pharmaceutical manufacturing, packaging, utility, and facility equipment. This role requires strong mechanical, electrical, and automation troubleshooting skills, along with knowledge of pharmaceutical processes, cGMP, and FDA requirements. The engineer supports production, leads maintenance activities, and ensures safety, quality, and compliance. Key Responsibilities
Perform preventive maintenance, repairs, and inspections on manufacturing and packaging equipment.
Troubleshoot mechanical/electrical issues, reduce downtime, and coordinate vendor support.
Maintain maintenance records, write SOPs and protocols, and support FAT/URS/FRS documentation.
Manage spare parts, purchase requisitions, and equipment inventory.
Collaborate with Production, Quality, and Engineering; train operators/technicians.
Support commissioning/qualification of equipment and utilities.
Promote safety, follow cGMP, and ensure compliance with all regulatory standards.
Oversee direct reports and assign daily maintenance tasks.
Requirements
Bachelor's in Mechanical/Electrical Engineering or related field (Master's a plus).
3+ years of experience maintaining pharmaceutical manufacturing/packaging equipment (OSD preferred).
Strong troubleshooting, communication, leadership, and problem-solving skills.
Knowledge of utilities, HVAC, GMP, and safety practices.
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