Team Member - Engineering (Process Mechanical)

Job Purpose

To ensure reliable operation, maintenance, and performance of pharmaceutical manufacturing equipment by executing preventive, breakdown, and improvement maintenance activities, ensuring compliance with cGMP, safety, and regulatory requirements, and supporting uninterrupted production operations.

Roles & Responsibilities

1. Equipment Maintenance Management

• Maintain and support manufacturing equipment, including:• Granulation (RMG, FBD)
• Compression (tablet presses)
• Coating machines
• Blenders, sifters, mills
• Filling and packing equipment
• Derma / Softgel / potent equipment (if applicable)

• Ensure equipment availability, reliability, and performance to meet production targets.
2. Preventive & Predictive Maintenance

• Plan and execute preventive maintenance schedules for all equipment.
• Perform inspection, lubrication, alignment, and replacement of critical components.
• Monitor equipment health and support predictive maintenance initiatives.
• Ensure adherence to planned maintenance systems and TPM practices.
3. Breakdown Maintenance & Troubleshooting

• Attend and resolve equipment breakdowns in a timely manner.
• Diagnose mechanical failures such as:• Bearing failures
• Gearbox issues
• Vibrations and misalignment
• Mechanical wear and tear

• Coordinate with cross‑functional teams to minimize downtime and production loss.
4. Installation, Qualification & Commissioning

• Support installation and commissioning of new equipment.
• Participate in equipment qualification (IQ, OQ, PQ) activities.
• Ensure mechanical systems meet design and validation requirements.
5. cGMP, Compliance & Documentation

• Follow cGMP, Good Engineering Practices (GEP), and SOPs.
• Maintain accurate records of:• Maintenance logs
• Equipment history
• Breakdown reports
• Spare part usage

• Support deviations, CAPA, change control, and audit requirements.
• Ensure equipment is maintained in a validated and compliant state.
6. Spare Parts & Inventory Management

• Identify and maintain critical spare parts inventory.
• Ensure timely availability of spares to prevent delays in maintenance.
• Coordinate with stores and procurement for spare part planning and procurement.
7. Cross‑Functional Coordination

• Work closely with Production for equipment readiness and maintenance scheduling.
• Coordinate with QA for compliance, documentation review, and validation activities.
• Support Instrumentation and Electrical teams for integrated troubleshooting.
8. Safety, EHS & Good Maintenance Practices

• Follow safety guidelines, PPE usage, and LOTO (Lock‑out/Tag‑out) procedures.
• Ensure safe handling of tools, machinery, and maintenance activities.
• Maintain 5S and housekeeping standards in maintenance areas.
• Report and rectify unsafe conditions or practices.
9. Continuous Improvement & TPM

• Participate in TPM (Total Productive Maintenance), Kaizen, and Lean initiatives.
• Support Jishu Hozen (JH) activities and operator capability building.
• Identify opportunities for equipment reliability improvement and cost reduction.
• Drive improvement in MTBF (Mean Time Between Failures) and MTTR (Mean Time to Repair).

Function: Engineering
Experience Level: Mid-Senior Level