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Job Profile: Facilities Management > Facilities Maintenance ESSENTIAL DUTIES AND RESPONSIBILITIES 負(fù)責(zé)工廠廠務(wù)設(shè)施方面的內(nèi)部外部審核，主要包括空調(diào)系統(tǒng)，壓縮空氣，真空系統(tǒng)，氮?dú)?，純水，VOC，潔凈室，蟲害控制等。 負(fù)責(zé)工廠潔凈室環(huán)境的日常監(jiān)測，數(shù)據(jù)整理，差異分析等（包含國內(nèi)及FDA等不同國家的監(jiān)測要求）。 負(fù)責(zé)工廠潔凈室相關(guān)程序文件的起草，修訂與整合。 負(fù)責(zé)工廠潔凈室相關(guān)驗(yàn)證文件IQ/OQ/PQ的起草與更新。 在工作中關(guān)注節(jié)能減排領(lǐng)域的機(jī)會(huì)，以達(dá)成公司總部及政府節(jié)能減排及環(huán)保要求 根據(jù)部門的節(jié)能目標(biāo)，提交精益改善項(xiàng)目。 必須理解工廠EHS規(guī)范，并在日常規(guī)劃及項(xiàng)目中嚴(yán)格貫徹工廠EHS的全部規(guī)范，保證工廠運(yùn)營安全 KNOWLEDGE REQUIREMENTS -熟悉潔凈室三大系統(tǒng)（空調(diào)，壓縮空氣，純化水）相關(guān)GMP，F(xiàn)DA，EU法律法規(guī) -對(duì)潔凈室三大系統(tǒng)（空調(diào)，壓縮空氣，純化水）設(shè)備、工藝、維修和維護(hù)保養(yǎng)方面較熟悉并具有能提供改進(jìn)意見的知識(shí)儲(chǔ)備 -對(duì)廠務(wù)公用設(shè)施（冷凍機(jī)、空壓機(jī)、純水、空調(diào)、制氮機(jī)、VOC等）設(shè)備、工藝、維保方面比較熟悉 -熟悉醫(yī)療器械法律法規(guī)（NMPA），ISO13485，美國FDA，ISO14644，ISO16292等體系知識(shí) -熟悉潔凈室，萬級(jí)或十萬級(jí)相關(guān)布局設(shè)計(jì)知識(shí) -英文技能為必備，需要良好的英文書面以及口語. - 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 本科以上學(xué)歷 5年以上醫(yī)療器械或醫(yī)藥工廠或相關(guān)潔凈廠房審核及驗(yàn)證經(jīng)驗(yàn) 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 - 5 years+