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Description:

The Associate Maintenance Engineer supports the upkeep, optimization, and reliability of pharmaceutical manufacturing equipment and utilities. The successful candidate will assist in the maintenance, troubleshooting, continuous improvement and plays a crucial part in ensuring smooth production of oral solid dosage forms and transdermal systems, including birth control patches. This role is critical to ensuring equipment reliability, operational efficiency, and compliance with GMP and regulatory standards.

Essential Functions:

+ Troubleshoot mechanical, electrical, pneumatic, and hydraulic issues and coordinate repairs to minimize downtime.

+ Assist in the preventive and corrective maintenance of production equipment such as tablet presses, coating machines, high-shear granulators, and transdermal patch coating, converting and packaging lines.

+ Support root cause analysis (RCA) and lead implementation of corrective and preventive actions (CAPA) related to equipment failures.

+ Maintain accurate documentation in line with GMP practices, including maintenance logs, work orders, and calibration records.

+ Collaborate with engineering, production, and quality teams to ensure reliable equipment performance.

Additional Responsibilities:

+ Participate in installation and qualification of new equipment (IQ/OQ/PQ).

+ Support continuous improvement initiatives and root cause investigations.

+ Ensure adherence to all EHS (Environmental, Health & Safety) policies and promote safe working practices.

+ Maintain spare parts inventory levels and suggest reordering as needed.

+ Manage external contractors and vendors, ensuring adherence to safety and regulatory standards.

+ Ensure compliance with all health, safety, and environmental standards and company policies.