Engineering Operations Manager

wuxi xdc singapore private limited; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

wuxi xdc singapore private limited in Singapore is seeking an experienced Engineering Operations Leader to drive GMP-compliant asset life-cycle management and ensure equipment calibration and maintenance meet regulatory standards.

You will lead the team, oversee PM reviews, spare parts strategy, deviation handling, capital projects, and continuous improvement through Lean and 5S, while managing essential documentation and master data for site equipment.

Qualifications

• 10+ years of maintenance work experience.
• 3+ years of team leadership experience.
• 3+ years of work experience in a pharmaceutical plant.

Responsibilities

• Lead the engineering operations team for GMP-compliant asset life-cycle management.
• Ensure calibration and maintenance meet regulatory requirements.
• Organize regular PM reviews to reduce equipment downtime.
• Manage spare parts and ensure low-cost availability with safety stock.
• Organize deviation reviews to reduce deviations.
• Coordinate capital expenditure projects for the engineering department.
• Monitor CAPA due dates, deviations, and change controls.
• Promote Lean Manufacturing and 5S within engineering.
• Provide admin support for the engineering department.
• Oversee asset management, PM, master data registration, and related systems.
• Manage equipment risk classification and usage instructions per risk assessment.
• Regularly review equipment management and annual PM plan.

Skills

Regulatory compliance

Calibration

Maintenance management

Lean manufacturing

5S

CAPA

Education

Bachelor's degree in engineering

Job description

Job responsibilities

• Lead the engineering operations team to ensure equipment life-cycle management meets GMP requirements.
• Ensure equipment calibration and maintenance meet appropriate regulatory requirements.
• Organize regular PM reviews to continuously reduce equipment downtime.
• Spare parts management, ensure spare parts availability at a low cost to support operations through spare parts classification and reasonable safety stock.
• Organize regular deviation reviews to improve the team's capacity to handle deviations, ultimately reducing the occurrence of deviations.
• Coordinate capital expenditure projects for the whole engineering department and continuously improve project management processes.
• Monitor quality system documents such as CAPA due dates, deviations, and change controls to ensure timely reminders and avoid overdue items.
• Promote Lean Manufacturing and 5S within the engineering department.
• Provide administrative support for the engineering department.
• Responsible for XDC Singapore site facility/utility/process equipment management procedure system building, including but no limit with asset management, PM management, master data registration, etc.
• Responsible for scientific classification of the management level of the equipment, according to the results of the risk assessment, the instructions for the use of the equipment and the actual situation.
• Responsible for relevant work of equipment ID maintenance registration and update.
• Responsible for regular review of the equipment management and the establishment and approval of annual PM plan.

Education background

Bachelor's degree or above in engineering, majoring in mechanical, electrical, or related fields.

Experience

• 10+ years of maintenance work experience.
• 3+ years of team leadership experience.
• 3+ years of work experience in a pharmaceutical plant