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 / Othertasks assigned byfacility 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WordExcel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.
Experience:
IC
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 &...
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 / Othertasks assigned byfacility 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WordExcel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.
Experience:
IC
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