Operations Support Engineer

Responsibilities

• Responsible for XDC Singapore site facility/utility/process equipment management procedure system building by refer XDC Wuxi Site, including but no limit with asset management, PM management, master data registration, change management, deviation management, CAPA, 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, deviation/CAPA/change management for site engineering management Dept(SEM), including completing deviation, CAPA, change control on time with relevant principals
• Responsible for regular review for the equipment management in SEM and the establishment and approval of annual PM plan
• Ensure that the team complies with EHS, GMP and other regulatory compliance by monitoring the operation state, ensuring equipment management compliance
• Accomplish other tasks from supervisor (e.g. part-time support for calibration work is needed during construction phase)

Requirements

• Diploma or above in process equipment & control engineering, pharmaceutical engineering, mechanical and electrical integration, and other related disciplines
• Minimum of 3 years of working experience in equipment management in the pharmaceutical industry
• Experience in GMP certification, FDA cGMP or EU GMP certification audit is 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 during the construction stage

Additional Information

Job Summary: Responsible for XDC Singapore site facility/utility/process equipment management procedure system building

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