工作內(nèi)容CONTENT
1. 水系統(tǒng)包括純化水、軟化水、熱水、純蒸汽、工業(yè)蒸汽、注射用水等系統(tǒng)。Water system include purified water、soften water、hot water、purified steam、plant steam、water for injection and other system.
2. 負(fù)責(zé)編寫水系統(tǒng)相關(guān)用戶需求標(biāo)準(zhǔn)（URS），提出設(shè)備采購申請。Responsible for drafting water system User Requirement Specification (URS) and proposing the application for equipment purchasing.
3. 負(fù)責(zé)水系統(tǒng)設(shè)備驗收，并撰寫設(shè)備相關(guān)操作和維護(hù)SOP。Responsible for water system equipment acceptance and preparing SOPs related equipment operation and maintenance.
4. 負(fù)責(zé)監(jiān)督水系統(tǒng)施工質(zhì)量，安裝調(diào)試期間協(xié)調(diào)。Responsible for supervising the construction quality of water system and coordinating during installation and commissioning.
5. 負(fù)責(zé)水系統(tǒng)設(shè)備預(yù)防性維護(hù)保養(yǎng)計劃的制定和實施。 Responsible for making and implementation water system equipment preventive maintenance plans.
6. 負(fù)責(zé)水系統(tǒng)設(shè)備全生命周期管理，包括采購、調(diào)試、服役、退役。 Responsible for the whole life cycle management of water system equipment, including procurement, commissioning, service and decommissioning.
7. 負(fù)責(zé)水系統(tǒng)設(shè)備日常操作、維修。 Responsible for water system equipment daily operations and maintenance and scrapping of equipment.
8. 負(fù)責(zé)水系統(tǒng)設(shè)備技術(shù)檔案的收集及管理。 Responsible for collecting and managing water system equipment technical files.
9. 負(fù)責(zé)建立水系統(tǒng)設(shè)備/儀表臺賬。 Responsible for setting up water system equipment/instrument list.
10. 負(fù)責(zé)水系統(tǒng)設(shè)備備品備件的選購。 Responsible for selective purchasing water system equipment spare parts.
11. 負(fù)責(zé)水系統(tǒng)設(shè)備突發(fā)問題的協(xié)調(diào)和解決。 Responsible for coordinating and solving water system equipment emergent problems.
12. 完成水系統(tǒng)變更、偏差調(diào)查和評估，并上報QA。 Complete water system change and deviation investigation and evaluation, and report to QA.
13. 對設(shè)備和廠房的變更做出評估。 Evaluate the changes of equipment and workshop.
14. 配合完成第三方和客戶審計和參觀等事情。 Cooperate with third party and customer audits and visits.
15. 完成其他相關(guān)工作。 Execute other related tasks.
教育背景和任職資格 EDUCATION BACKGROUND and QUALIFICATION
1. 藥學(xué)、機電、機械或其他相關(guān)專業(yè)?？萍耙陨蠈W(xué)歷。 College degree or above in pharmaceutical, electromechanical, mechanical or other related majors.
2. 2年以上制藥或相關(guān)行業(yè)設(shè)施安裝、維修及保養(yǎng)工作經(jīng)驗。 More than 2 years’ experience in equipment installation, repair and maintenance in pharmaceutical or related industries.
3. 熟悉藥品質(zhì)量規(guī)范和GMP標(biāo)準(zhǔn)。 Familiar with drug quality specifications and GMP standards.
4. 具備水系統(tǒng)驗證及相關(guān)工作經(jīng)驗。 Have the experience in water system validation and related work.
5. 具備專業(yè)技術(shù)能力，具備專業(yè)的機械設(shè)備安裝、維修以及保養(yǎng)知識，具備熟練的設(shè)備維修及保養(yǎng)操作技能。 Have professional technical ability, have professional knowledge of mechanical equipment installation, repair and maintenance, and have skillful operational skills of equipment repair and maintenance.
6. 具備較強的問題分析、判斷及解決能力。 Have strong ability of problem analysis, judgment and resolution.
7. 具備良好的溝通交流能力。 Have good communication ability.
8. 熟練使用Office、CAD等辦公軟件。 Skilled in Office, CAD, and other office software.
9. 具備一定的英語讀寫能力。 Have Good English reading and writing skills.