Mechanical Engineer

Role & responsibilities

• Monitor and maintain pharmaceutical manufacturing equipment to ensure uninterrupted production and compliance with GMP requirements.
• Execute preventive, predictive, and breakdown maintenance activities for production and utility equipment.
• Supervise installation, erection, testing, commissioning, and qualification of new mechanical equipment and systems.
• Maintain and troubleshoot equipment such as HVAC systems, Air Handling Units (AHU), chillers, compressors, boilers, pumps, reactors, pressure vessels, mixers, granulators, fluid bed dryers (FBD), and packing machines.
• Ensure proper operation and maintenance of cleanroom systems, utility systems, and critical process equipment.
• Coordinate with production, quality assurance (QA), quality control (QC), engineering, and validation teams to support manufacturing operations.
• Prepare maintenance schedules and ensure timely execution of preventive maintenance activities.
• Conduct root cause analysis (RCA) for equipment failures and implement corrective and preventive actions (CAPA).
• Review engineering drawings, P&IDs, equipment layouts, and technical specifications for maintenance and project activities.
• Ensure compliance with GMP, EHS standards, SOPs, and regulatory requirements during maintenance activities.
• Monitor utility systems such as HVAC, purified water systems, compressed air systems, steam systems, and chilled water systems.
• Coordinate vendor activities, AMC contractors, and service providers for maintenance and project execution.
• Maintain spare parts inventory and coordinate procurement of critical mechanical components.
• Participate in equipment qualification activities including IQ, OQ, PQ, and validation support.
• Ensure implementation of Permit-to-Work (PTW), Lockout-Tagout (LOTO), and safety procedures during maintenance and shutdown activities.
• Prepare and maintain maintenance records, equipment history cards, breakdown reports, and compliance documentation.