Department Details
Role Summary
- Roles & Responsibilities
- Responsible for ensuring equipment & plant reliability to support production schedules, building team capability to minimize dependency on OEM's (Original Equipment Manufacturers), and leading the Maintenance Efficiency Program and engineering excellence.
- Role involves leading the engineering team of Drug Product blocks and utilities.
- Having good hands-on experience of high speed vial / cartridge and PFS filling line with RABs / Isolator systems.
- Have worked on Devices and Packing lines.
- Leading the engineering function during all regulatory audits, ensuring all time audit readiness
- Responsibilities include leading safety standards & behavior in engineering & across, collaborating with cross functional teams for seamless support, and ensuring implementation of & adherence to QMS (Quality Management System).
- Responsible for the overall routine and non- routine maintenance of plant and equipment
- Responsible for the implementation of continuous improvement projects, and ensuring adherence to defined standards and procedures
- Ensure annual service contracts for upkeep and troubleshoot of process equipment and utilities, inclusive of plant and facility maintenance.
- Responsible for budget and financial control for operating expenses of process, facility utilities and energy budgets.
- Coordinate with statutory, regulatory and government agencies for compliance with applicable acts
- Implement energy conservation measures and water management procedures, ensure adherence to PMP (Preventive Maintenance Program) / Validation & calibration schedule, and review engineering SOP (Standard Operating Procedures) and other relevant documents along with QA (Quality Assurance).
- Review team member's activities / schedules for compliance (for review of preventive maintenance, calibration, building maintenance schedules)
- Impart periodic GMP (Good Manufacturing Practices) refresher trainings to team along with recruitment, retention, supervision and motivation of personnel.
- Responsible for monitoring of spares, ensuring availability of adequate spares, consumables and resources, and implement maintenance management system through SAP system.
- Ensure 100% safety compliance and follow continuous improvement programs and by supporting safety and other functions to avoid any safety incidents
Key Responsibilities
Roles & ResponsibilitiesResponsible for ensuring equipment & plant reliability to support production schedules, building team capability to minimize dependency on OEM's (Original Equipment Manufacturers), and leading the Maintenance Efficiency Program and engineering excellence.Role involves leading the engineering team of Drug Product blocks and utilities.Having good hands-on experience of high speed vial / cartridge and PFS filling line with RABs / Isolator systems.Have worked on Devices and Packing lines.Leading the engineering function during all regulatory audits, ensuring all time audit readinessResponsibilities include leading safety standards & behavior in engineering & across, collaborating with cross functional teams for seamless support, and ensuring implementation of & adherence to QMS (Quality Management System).Responsible for the overall routine and non- routine maintenance of plant and equipmentResponsible for the implementation of continuous improvement projects, and ensuring adherence to defined standards and proceduresEnsure annual service contracts for upkeep and troubleshoot of process equipment and utilities, inclusive of plant and facility maintenance.Responsible for budget and financial control for operating expenses of process, facility utilities and energy budgets.Coordinate with statutory, regulatory and government agencies for compliance with applicable actsImplement energy conservation measures and water management procedures, ensure adherence to PMP (Preventive Maintenance Program) / Validation & calibration schedule, and review engineering SOP (Standard Operating Procedures) and other relevant documents along with QA (Quality Assurance).Review team member's activities / schedules for compliance (for review of preventive maintenance, calibration, building maintenance schedules)Impart periodic GMP (Good Manufacturing Practices) refresher trainings to team along with recruitment, retention, supervision and motivation of personnel.Responsible for monitoring of spares, ensuring availability of adequate spares, consumables and resources, and implement maintenance management system through SAP system.Ensure 100% safety compliance and follow continuous improvement programs and by supporting safety and other functions to avoid any safety incidentsEducational Qualifications
Required Education Qualification :
Required Experience : 20 - 25 years