Engineering Operation Manager

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.
• Accomplish other tasks from supervisor.

Requirements

• Bachelor's degree or above in engineering, majoring in mechanical, electrical, or related fields.
• 10+ years of maintenance work experience.
• 3+ years of team leadership experience.
• 3+ years of work experience in a pharmaceutical plant.
• Good knowledge of GMP.
• Experience in GMP certification, FDA cGMP or EU GMP certification audit is preferred
• Lean manufacturing mindset and knowledge preferred.
• Familiarity with the Maximo maintenance management system preferred.
• A team player with good logical thinking ability and communication skills
• Proficient in the Microsoft Office suite of applications
• Able to travel between Singapore and China as needed
• Positive attitude and strong teamwork skills.

Additional Information

Job Summary: Responsible for XDC Singapore site engineering management procedure system building up. Lead the engineering operations team to ensure equipment life-cycle management meets GMP requirements.

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