(Sr.)F&E Management Manager (高级)设施设备管理经理

1. Prepare, review and update documented User Requirement, Functional Specifications, and Detailed Specifications.
2. Write and update the SOPs related to management of equipment (e.g. System ID, system validation status) and provide the training to the users.
编制及更新设备管理相关的SOP(例如系统ID、 系统验证状态等)并给用户进行培训。
3. Generate the equipment maintenance plan and establish the process equipment Maintenance Master Schedule.
4. Critically assess spare parts requirement to generate the purchase list of the safety stock. If any shortage after consumption, reorder the parts.
5. Ensure department GMP procedures are in compliance with relevant Company policies and Regulatory requirements.
6. Facilitate execution of Deviations, investigations, CAPA, etc. related to quality.
7. Establish and manage the efficient operation of the Department documentation control system, including the drawings.
8. Develop and coach the team members, build up a professional team to provide maintenance that ensures compliance with GMP for the Operation Service Department. Liaise with other departments to facilitate maintenance in compliance with GMP. Ensure the services are delivered with high quality and efficiency.
发展和辅导团队成员,建立一支专业的业务流程与合规团队,执行维护,确保运营支持部GMP流程的合规性。 与其他部门良好合作, 促进系统维护和GMP流程相关工作的顺利进行。确保提供高质高效的服务。
9. This position is also the financial steward for the department organization that ensures compliance to cost accounting practices and company financial requirements and prudently manages annual spending against OPEX budgets.


1. Bachelor in Engineering or pharmaceutical production.
2. Minimum of 5 years of experience in facility operation and management within pharmaceutical or medical device industries. Or at least 8 years of industry experience in calibration in pharmaceutical, medical device, healthcare, or food industries.
3. Detailed knowledge of the operation of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, and HVAC) and general building services (access control, boiler, waste neutralization, chillers, cooling towers, electrical power, emergency generators, compressed gases)’
4. Technical knowledge regarding the design, operation, preventative maintenance and trouble-shooting of site utilities is required.
5. Experience in equipment commissioning, qualification, and validation programs is required.
6. Sound knowledge of Good Manufacturing Practices including NMPA, PIC/S, and US-FDA guidelines with focus on API and/or sterile product manufacture;