Spclst, Engineering (CCP for Biomedical Manufacturing Industry)

1. Corrective & Preventive Maintenance

• Ensure timely resolution and follow-up of equipment-related issues, unplanned events, and opportunities identified during daily operations or maintenance walkthroughs.

• Lead troubleshooting activities for equipment breakdowns and process interruptions.

• Provide technical expertise and guidance to maintenance technicians to ensure efficient restoration of equipment operation.

• Monitor equipment performance and implement corrective measures to prevent recurrence of failures.

• Update maintenance plans based on equipment performance findings and failure trends.

• Ensure all scheduled internal and external preventive maintenance activities are completed on time.

• Review maintenance effectiveness and recommend optimization opportunities to improve equipment performance and availability.

• Support planning and coordination of maintenance activities to minimize operational disruption.

3. Equipment Reliability

• Implement reliability-centered maintenance methodologies and asset reliability programs.

• Analyze equipment performance data and identify opportunities to improve reliability and maintainability.

• Ensure equipment downtime remains within operational and capacity planning expectations.

• Support reliability reviews, failure analysis, and asset health assessments.

4. Critical Spare Parts Management

• Support procurement and inventory management activities to ensure critical parts availability.

• Work with supply chain and maintenance teams to eliminate risks associated with spare part shortages.

5. Deviation, Incident and Investigation Support

• Support investigations related to equipment failures, deviations, atypical events, and safety incidents.

• Develop and implement effective corrective and preventive actions (CAPA).

• Provide technical expertise during internal audits, regulatory inspections, and quality investigations.

6. Equipment Change Control & Projects

• Support implementation of equipment change controls and engineering projects.

• Conduct impact assessments and risk evaluations for equipment modifications.

• Manage project schedules, vendor coordination, resource planning, and material procurement for assigned activities.

• Ensure modifications comply with GMP, safety, and regulatory requirements.

7. System Subject Matter Expert (SME) Responsibilities

Where assigned as a System SME (e.g., Purified Water System, HVAC, Utilities, Packaging Equipment):

• Act as technical owner and subject matter expert for designated systems.

• Support day-to-day system operation and continuous improvement initiatives.

• Lead system-related investigations, deviations, and change controls.

• Serve as the primary IPT representative for system governance meetings and audits.

• Support lifecycle management and long-term reliability strategies for assigned systems.

Qualifications & Experience

Education

• Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Mechatronics Engineering, Chemical Engineering, or related Engineering discipline.

Experience

• Minimum 3-5 years of experience in maintenance, reliability engineering, manufacturing engineering, or equipment support within a regulated manufacturing environment.

• Experience supporting GMP manufacturing operations is preferred.

• Experience in pharmaceutical, biotechnology, medical device, FMCG, semiconductor, or similar highly regulated industries is an advantage.