19 Aug
|
Immacule Life Sciences
|
Nalagarh
19 Aug
Immacule Life Sciences
Nalagarh
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 recent 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
📌 Process Equipment Engineer (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh