Process Equipment Engineer

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