Facility Engineer

协助部门负责人实施洁净生产车间相关动力、设备设施的日常运行管理、维保服务商管理、验证确认管理、计量管理，以及新建或改造设备设施的项目管理工作。Assist facility manager to manage daily operation, maintenance, qualification, metrology and maintenance supplier of cleanroom related utility/ facility, and project management on new or renovation facility projects.

Main Responsibilities & Tasks:

制订洁净车间相关设备设施的维护保养计划，并按照计划监督日常维护、保养的执行，以确保洁净厂房在符合标准要求的情况下正常运行/To draft the cleanroom related facility maintenance plan, and to supervise the execution of daily maintenance, to ensure cleanroom is running in a good condition.
起草、完善体系要求的洁净厂房设施以及环境监控系统（EMS）相关SOP文件，并严格按照文件要求实施管理 /To draft, improve and maintain procedure documents of cleanroom facility and environment monitoring system, and manage the maintenance strictly according to documents.
负责设施相关不符合项的发起、调查，并相应制定纠正预防措施 /To draft facility related NC, and then investigate the root cause, and make CAPA plan accordingly.
负责设备设施的DQ/IQ/OQ/PQ等验证确认工作，以及定期回顾性验证工作，编写相关验证方案和验证报告, 包括洁净车间、压缩空气系统、纯化水系统、计算机化系统等。/Facility qualification work, such as DQ/IQ/OQ/PQ, and periodic facility re-qualification， drafting qualification protocol and report, including cleanrooms, compressed air sys, purifying water sys and CSV.
仪器仪表的校验管理/Calibration management.
内部库房的设备设施管理，进行相关的温湿度周期性确认工作/Facility management of internal warehouse, be responsible for warehouse humidity and temperature periodic requalification.
参与施工过程管理、完工验收工作 /Participate in construction management and acceptance of new projects.
完成上级交办的其它工作 / Other tasks assigned by facility manager.

Qualifications & Skills:

本科及以上学历，暖通、机械、电气、自动化等理工科专业/Bachelor degree or above major in HVAC, mechanical, electrical, automation or engineering.
设备设施管理工作经验和工程类项目管理经验，8年以上医药类或医疗器械类洁净厂房设施，包括洁净空调、BMS/EMS、纯水、压缩空气等系统的施工、运行、验证确认管理经验 /Facility and engineering project management experience. More than 8 years pharmaceutical or medical devices industry cleanroom facility experience, including new project, operation, qualification management on HVAC, BMS/EMS, purified water, compressed air, ect.
GMP背景 /Solid GMP experience.
具备较强的沟通、协调、问题发现和解决，以及快速学习能力 /Good skill on communication, coordination, troubleshooting; Quick learner.
工作积极主动，责任心强，工作严谨细致，结果导向，抗压能力强/Proactive, strong sense of responsibility, strict and meticulous, result oriented, can work under pressure.
熟练使用Word，Excel等办公工具软件/Familiar with office tool such as Word, Excel, etc.
有一定英语读写水平为佳 /English capability is a plus

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers

Details

Location

Beijing, China

Experience

Min. 8 years8+ years in pharma/medical devices cleanroom facility experience including HVAC, BMS/EMS, purified water, compressed air systems

Technologies

Csv

Main Responsibilities & Tasks:

制订洁净车间相关设备设施的维护保养计划，并按照计划监督日常维护、保养的执行，以确保洁净厂房在符合标准要求的情况下正常运行/To draft the cleanroom related facility maintenance plan, and to supervise the execution of daily maintenance, to ensure cleanroom is running in a good condition.
起草、完善体系要求的洁净厂房设施以及环境监控系统（EMS）相关SOP文件，并严格按照文件要求实施管理 /To draft, improve and maintain procedure documents of cleanroom facility and environment monitoring system, and manage the maintenance strictly according to documents.
负责设施相关不符合项的发起、调查，并相应制定纠正预防措施 /To draft facility related NC, and then investigate the root cause, and make CAPA plan accordingly.
负责设备设施的DQ/IQ/OQ/PQ等验证确认工作，以及定期回顾性验证工作，编写相关验证方案和验证报告, 包括洁净车间、压缩空气系统、纯化水系统、计算机化系统等。/Facility qualification work, such as DQ/IQ/OQ/PQ, and periodic facility re-qualification， drafting qualification protocol and report, including cleanrooms, compressed air sys, purifying water sys and CSV.
仪器仪表的校验管理/Calibration management.
内部库房的设备设施管理，进行相关的温湿度周期性确认工作/Facility management of internal warehouse, be responsible for warehouse humidity and temperature periodic requalification.
参与施工过程管理、完工验收工作 /Participate in construction management and acceptance of new projects.
完成上级交办的其它工作 / Other tasks assigned by facility manager.

Qualifications & Skills:

本科及以上学历，暖通、机械、电气、自动化等理工科专业/Bachelor degree or above major in HVAC, mechanical, electrical, automation or engineering.
设备设施管理工作经验和工程类项目管理经验，8年以上医药类或医疗器械类洁净厂房设施，包括洁净空调、BMS/EMS、纯水、压缩空气等系统的施工、运行、验证确认管理经验 /Facility and engineering project management experience. More than 8 years pharmaceutical or medical devices industry cleanroom facility experience, including new project, operation, qualification management on HVAC, BMS/EMS, purified water, compressed air, ect.
GMP背景 /Solid GMP experience.
具备较强的沟通、协调、问题发现和解决，以及快速学习能力 /Good skill on communication, coordination, troubleshooting; Quick learner.
工作积极主动，责任心强，工作严谨细致，结果导向，抗压能力强/Proactive, strong sense of responsibility, strict and meticulous, result oriented, can work under pressure.
熟练使用Word，Excel等办公工具软件/Familiar with office tool such as Word, Excel, etc.
有一定英语读写水平为佳 /English capability is a plus

About Sartorius

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. www.sartorius.com/careers