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) seeks a qualified Maintenance/Reliability Engineer to lead corrective and preventive maintenance activities in a highly regulated manufacturing environment. You will mentor technicians, analyze equipment performance, and drive CAPA and change controls to improve uptime.

The role requires a Bachelor's degree in engineering and 3–5 years in GMP manufacturing or similar; experience in pharma/biotech or related industries is advantageous.

Qualifications

• 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.

Responsibilities

• Lead corrective & preventive maintenance activities and ensure timely resolution of equipment issues.
• Provide technical guidance to maintenance technicians to restore equipment operation efficiently.
• Monitor equipment performance and implement corrective measures to prevent recurrence of failures.
• Support planning and coordination of maintenance activities to minimize disruption.
• Implement reliability-centered maintenance methodologies and asset reliability programs.
• Analyze equipment data to identify opportunities to improve reliability and maintainability.
• Support investigations related to equipment failures, deviations, and safety incidents.
• Support equipment change controls and engineering projects, including risk assessments and schedule management.

Skills

Maintenance

Reliability engineering

Manufacturing engineering

GMP

CAPA

Quality investigations

Project management

System SME

Education

Bachelor's Degree in Engineering

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.