Facility Subject Matter Expert - Sterile Medical Validation

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

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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