We are looking for a skilled and proactive Process Equipment Maintenance Engineer to join our Injectable manufacturing facility. The candidate will be responsible for the operation, maintenance, troubleshooting, and upkeep of process equipment to ensure uninterrupted production and compliance with GMP standards.
Key Responsibilities
1. Perform preventive, breakdown, and corrective maintenance of injectable manufacturing equipment.
2. Ensure smooth operation and maintenance of process equipment such as vial washing machines, tunnel sterilizers, filling machines, capping machines, autoclaves, and lyophilizers.
3. Diagnose and resolve mechanical, electrical, and instrumentation-related issues to minimize equipment downtime.
4. Execute maintenance activities in compliance with GMP, safety,
and regulatory requirements.
5. Prepare and maintain maintenance logs, breakdown reports, and equipment history records.
6. Coordinate with Production, QA, QC, Engineering, and Validation teams for maintenance and qualification activities.
7. Participate in equipment installation, commissioning, qualification, and validation activities. Monitor machine performance and implement continuous improvement initiatives.
8. Ensure timely availability of spare parts and consumables required for maintenance activities.
9. Support audit readiness and maintain proper documentation as per company procedures.