Spclst, Engineering (CCP for Biomedical Manufacturing Industry)

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) is seeking a Maintenance Engineer to drive corrective and preventive maintenance across critical pharmaceutical equipment, ensuring minimal downtime and compliant operations.

The role requires a Bachelor's degree in engineering and 3–5 years in regulated manufacturing, with GMP experience preferred, and a proactive approach to reliability improvement and CAPA.

Qualifications

• Bachelor's Degree in Mechanical, Electrical, Mechatronics, Chemical or related Engineering discipline.
• 3-5 years of experience in maintenance, reliability engineering, manufacturing engineering, or equipment support in a regulated manufacturing environment.
• Experience supporting GMP manufacturing operations is preferred; pharma/biotech or other highly regulated industries are an advantage.

Responsibilities

• Lead corrective and preventive maintenance activities to resolve equipment issues, unplanned events, and recurrent problems.
• Provide technical guidance to maintenance technicians to restore equipment operation efficiently.
• Monitor equipment performance and implement corrective actions to prevent recurrence.
• Review and update maintenance plans to optimize reliability and availability.
• Support procurement and inventory management of critical spare parts.
• Assist investigations, CAPA, and regulatory quality investigations.
• Support equipment change control, projects, risk assessments, and supplier coordination.
• Act as System SME for designated systems and drive lifecycle improvements.

Education

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

Job description

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.