JD, Facility Sterile medical Validation SME .docx
ESSENTIAL DUTIES AND RESPONSIBILITIES
负责工厂厂务设施方面的内部外部审核，主要包括空调系统，压缩空气，真空系统，氮气，纯水，VOC，洁净室，虫害控制等。

负责工厂洁净室(包括电子无尘洁净房，医疗无菌洁净房) 环境的日常监测，数据整理，差异分析等（包含国内及FDA等不同国家的监测要求）。

负责工厂洁净室相关程序文件的起草，修订与整合。

负责工厂洁净室相关验证文件IQ/OQ/PQ的起草与更新。

在工作中关注节能减排领域的机会，以达成公司总部及政府节能减排及环保要求

根据部门的节能目标，提交精益改善项目。

必须理解工厂EHS规范，并在日常规划及项目中严格贯彻工厂EHS的全部规范，保证工厂运营安全

KNOWLEDGE REQUIREMENTS

****熟悉洁净室三大系统（空调，压缩空气，纯化水）相关GMP，FDA，EU法律法规

****对洁净室三大系统（空调，压缩空气，纯化水）设备、工艺、维修和维护保养方面较熟悉并具有能提供改进意见的知识储备

****对厂务公用设施（冷冻机、空压机、纯水、空调、制氮机、VOC等）设备、工艺、维保方面比较熟悉

****熟悉医疗器械法律法规（NMPA），ISO13485，美国FDA，ISO14644，ISO16292等体系知识

****熟悉洁净室，万级或十万级相关布局设计知识

****英文技能为必备，需要良好的英文书面以及口语.

**** Familiar with GMP, FDA, EU and other laws and regulations related to the three major systems of cleanroom (air conditioning, compressed air, purified water)

**** Familiar with the equipment, processes, maintenance and upkeep of the three major systems (air conditioning, compressed air, purified water) in cleanrooms and has knowledge that can provide suggestions for improvement

**** Familiar with plant utilities (chiller, air compressor, pure water, air conditioning, nitrogen generator, VOC, etc.) equipment, processes, maintenance

**** Familiar with medical device laws and regulations (NMPA), ISO13485, FDA, ISO14644, ISO16292 and other system knowledge

****Familiar with the layout design knowledge of cleanrooms, including those of Class 10,000 or Class 100,000

**** English skills are required. Good written and spoken English is necessary.

EDUCATION & EXPERIENCE REQUIREMENTS

本科以上学历

5年以上医疗器械或医药工厂或相关洁净厂房审核及验证经验

Bachelor’s degree or above

More than 5 years of experience in the factory affairs regarding medical devices or pharmaceutical factories or related clean workshops, Audit or validation related experience is more preferred

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