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. 負責編寫水系統(tǒng)相關用戶需求標準（URS），提出設備采購申請。Responsible for drafting water system User Requirement Specification (URS) and proposing the application for equipment purchasing.
3. 負責水系統(tǒng)設備驗收，并撰寫設備相關操作和維護SOP。Responsible for water system equipment acceptance and preparing SOPs related equipment operation and maintenance.
4. 負責監(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. 負責水系統(tǒng)設備預防性維護保養(yǎng)計劃的制定和實施。 Responsible for making and implementation water system equipment preventive maintenance plans.
6. 負責水系統(tǒng)設備全生命周期管理，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. 負責水系統(tǒng)設備日常操作、維修。 Responsible for water system equipment daily operations and maintenance and scrapping of equipment.
8. 負責水系統(tǒng)設備技術檔案的收集及管理。 Responsible for collecting and managing water system equipment technical files.
9. 負責建立水系統(tǒng)設備/儀表臺賬。 Responsible for setting up water system equipment/instrument list.
10. 負責水系統(tǒng)設備備品備件的選購。 Responsible for selective purchasing water system equipment spare parts.
11. 負責水系統(tǒng)設備突發(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. 完成其他相關工作。 Execute other related tasks.
教育背景和任職資格 EDUCATION BACKGROUND and QUALIFICATION
1. 藥學、機電、機械或其他相關專業(yè)專科及以上學歷。 College degree or above in pharmaceutical, electromechanical, mechanical or other related majors.
2. 2年以上制藥或相關行業(yè)設施安裝、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標準。 Familiar with drug quality specifications and GMP standards.
4. 具備水系統(tǒng)驗證及相關工作經(jīng)驗。 Have the experience in water system validation and related work.
5. 具備專業(yè)技術能力，具備專業(yè)的機械設備安裝、維修以及保養(yǎng)知識，具備熟練的設備維修及保養(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.