崗位職責(zé): 1.負(fù)責(zé)編寫用戶需求標(biāo)準(zhǔn)(URS),提出設(shè)備使用申請; Responsible for preparing User Requirement Specification (URS) and submitting the equipmentapplication; 2.負(fù)責(zé)設(shè)備驗(yàn)收,并撰寫設(shè)備相關(guān)SOP; Responsible for equipment acceptance and preparing related equipment SOP; 3.負(fù)責(zé)起草設(shè)備的設(shè)計(jì)確認(rèn)、安裝確認(rèn)和運(yùn)行確認(rèn)文件,并實(shí)施; Responsible for preparing equipment Design Qualification (DQ), Installation Qualification(IQ) and Operation Qualification (OQ) document, and performing qualification; 4.負(fù)責(zé)設(shè)備的日常保養(yǎng); Responsible for equipment routine maintenance; 5.負(fù)責(zé)設(shè)備維修和報(bào)廢; Responsible for equipment repair and scrapping; 6.負(fù)責(zé)設(shè)備技術(shù)檔案的收集及管理; Responsible for collecting equipment document and management; 7.負(fù)責(zé)建立GMP Lab設(shè)備/儀表臺賬; Responsible for setting up equipment/instrument list. 8.負(fù)責(zé)GMP Lab儀器/儀表的校驗(yàn)。 Responsible for the calibration of instrument. 任職資格: QUALIFICATION: 1.本科以上學(xué)歷,自動化或機(jī)械設(shè)備相關(guān)專業(yè); 2.具有設(shè)備相關(guān)維修或設(shè)備管理經(jīng)驗(yàn)至少2年,熟悉設(shè)備維保相關(guān)流程(真空泵,冷缺塔,冷機(jī),空壓機(jī),TCU,反應(yīng)釜等)。