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 new equipment or upgrades and manage Opex within defined limits, optimizing resource allocation for cost efficiency.
