- Process Equipment Management and Operational Excellence :
- Experience of handling breakdowns of process equipment , including isolators, vial filling machines, autoclaves, and robotic powder filling machines, targeting zero breakdowns for uninterrupted production.
- Expertise in programming, development, and troubleshooting of PLC (Programmable Logic Controller) and SCADA (Supervisory Control and Data Acquisition) systems for optimized control and monitoring.
- Coordinate preventive and breakdown maintenance activities within set time frames, ensuring equipment is always available and in optimal condition.
- Identify and establish alternate vendors for process equipment spares to reduce costs and improve availability timelines, ensuring all critical spare parts are on hand.
- Oversee and ensure the timely completion of all process engineering activities
- Preventive Maintenance and Validation :
- Develop, monitor, and execute a comprehensive Preventive Maintenance Plan for all plant equipment to minimize downtime and extend equipment lifecycle.
- Support to validations and revalidations of all areas and equipment per the Validation Master Plan to maintain compliance and operational standards.
- Implementation and Support online documentation and data integrity for all process areas and equipment, ensuring full compliance with regulatory and validation requirements.
- Compliance and Quality Management :
- Ensure that all process engineering activities are compliant with the Quality Management System (QMS), contributing to continuous quality and operational improvements.
- Prepare, review, verify, and enforce Standard Operating Procedures (SOPs) to maintain standardized practices across the department.
- Conduct timely calibration of all critical equipment, ensuring it remains within validated specifications.
- Lead efforts to prepare for and face regulatory inspections with maintaining the facility and processes in full compliance with industry standards.
- Leadership and Team Development :
- Set and monitor annual department targets, tracking progress to ensure compliance with operational goals and performance metrics.
- Manage team shift schedules to ensure adequate coverage and maintain process continuity.
- Ensure completion of all departmental training within specified timelines and provide regular feedback through appraisals.
- Ensuring adherence to safety rules and regulations and supporting Environmental, Health, and Safety initiatives.
- Budgeting and Capex Management :
- Identify Process related Capex requirements for recent equipment or upgrades and manage Opex within defined limits, optimizing resource allocation for cost efficiency.