Process Equipment Engineer

Immacule Life Sciences; Solan; On-site; INR 600,000 - 900,000; Full time

Job summary

Immacule Life Sciences is seeking a Maintenance Engineer to plan and execute preventive maintenance of sterile process equipment, including vial washing machines, depyrogenation tunnels, filling & sealing machines, and CIP/SIP systems. Ensure PM adherence, equipment history, and documentation to minimize downtime.

The role requires coordination with Production, QA and Validation for qualification, validation and maintenance activities, maintaining records, and ensuring compliance with GMP and

Qualifications

• Planning and execution of preventive maintenance of sterile process equipment.
• Responsible for breakdown maintenance, troubleshooting and timely restoration.

Responsibilities

• Ensure proper documentation and compliance with GMP, cGMP, SOPs and regulatory requirements.
• Maintain PM planners and equipment history logs.

Skills

Preventive maintenance

Troubleshooting

Equipment maintenance

Job description

Role & responsibilities

• Responsible for planning and execution of Preventive Maintenance (PM) of sterile process equipment as per the approved schedule.
• Responsible for breakdown maintenance, troubleshooting and timely restoration of sterile process equipment to minimize equipment downtime.
• Ensure effective maintenance of critical sterile equipment such as Vial Washing Machines, Depyrogenation Tunnels, Filling & Sealing Machines, RABS/Isolators, Autoclaves, Lyophilizers, CIP/SIP Systems and other associated equipment.
• Monitor and review PM execution to ensure adherence to approved schedules and maintenance procedures.
• Coordinate with Production, QA and Validation teams for equipment qualification, validation and maintenance activities.
• Maintain and update PM Planners, equipment history logs, breakdown records and maintenance documentation.
• Ensure proper documentation and compliance with GMP, cGMP, SOPs and regulatory requirements.
• Ensure availability of critical spares, consumables and maintenance materials for sterile process equipment.
• Coordinate with OEMs/vendors for technical support, troubleshooting, servicing and preventive maintenance.
• Monitor equipment performance and identify opportunities for reliability improvement and reduction of recurring breakdowns.
• Support installation, commissioning, qualification and validation of new sterile process equipment.
• Participate in equipment-related deviation investigations, root cause analysis and CAPA implementation.
• Ensure maintenance activities are performed without compromising sterility, product quality and GMP requirements.
• Maintain proper records of equipment breakdowns, PM, calibration, qualification and maintenance history.
• Ensure compliance with EHS requirements during all maintenance and engineering activities.

Preferred candidate profile