国产中文无码av每日更新在线观看, 亚洲天堂中文字幕一区二区三区免费, 国产口爆吞精在线观视频-黄色国产, 92福利-国内精品久久久久久99,亚洲成AV人A片不卡无码,浪潮AV无码专区,老熟女败火白浆,中文字幕日产av,色情日本免费看大片

Education Background: 教育背景 ? Bachelor degree major in mechanical and automation engineering, electrical or similar field. 機械工程、自動化工程、電氣工程或相關學科大學本科畢業(yè)或以上學歷 ? Education or training in GMP and LEAN. 接受過GMP規(guī)則和LEAN相關培訓 ? Excellent English skill in written and spoken. 熟練的英語聽說讀寫技能。 Professional Experience專業(yè)經(jīng)驗: ? Minimum 3-5 years of working experience in manufacturing factory. Prefer clean room or aseptic area experience. 兩年以上生產(chǎn)制造企業(yè)工作經(jīng)驗，最好有無菌環(huán)境的經(jīng)驗。 ? Experience of equipment maintenance in aseptic process of cGMP regulated pharmaceutical industry. cGMP規(guī)范的制藥廠無菌生產(chǎn)流程的設備維護經(jīng)驗。 ? Knowledge in the following systems: pneumatic system, utilities, instrument and electrical, especially PLC and motion control system. In addition ability and experience with automated records systems such as SAP system. 具備如下系統(tǒng)的專業(yè)知識：氣動系統(tǒng)，公用工程，儀表，動力控制，SAP系統(tǒng)。 Key areas of responsibility 主要工作職責: Maintenance engineer is responsible for implementing corrective maintenance and preventive maintenance work according to SOP. To ensure AP equipment are running with high performance and low variation. Perform equipment incident handling, machine improvement and optimization that to ensure process in compliance with safety, production or quality requirements as well as standards. 維修工程師負責按照標準操作流程執(zhí)行生產(chǎn)設備維修工作，確保無菌生產(chǎn)設備穩(wěn)定高效地運行。處理設備問題，執(zhí)行設備改進和優(yōu)化，以確保工作流程符合安全、生產(chǎn)、質(zhì)量以及標準的要求。 Main Job Tasks 主要工作任務: ? Take the responsibility of machine owner. Implement corrective maintenance and preventive maintenance according to SOP. Ensure all machines troubleshooting timely. Ensure machines running well with high performance and low variation. Ensure safety when working with machine. 擔任設備負責人，遵循SOP的要求執(zhí)行生產(chǎn)設備日常維修保養(yǎng)和定期檢修，及時解決問題確保設備運行狀況良好。保證工作安全。 ? Ensure stability batches, media fill, PV batches and production batches are executed according to milestones. Clear communicate with production team to make sure production will not be impacted. 保證生產(chǎn)按計劃執(zhí)行，與生產(chǎn)團隊良好溝通以確保設備維修活動不影響生產(chǎn)。 ? Establish and improve equipment maintenance standards, processes/procedures and system to meet GMP requirement. 按照GMP的要求建立和改進設備維護標準、工作流程和程序等。 ? Handle NC, investigate the root cause and cooperate with production team and process team together try to close it by cLEAN tools systematically. 處理偏差，調(diào)查問題的根本原因，與生產(chǎn)團隊和工藝支持團隊一起合作運用精益生產(chǎn)的工具系統(tǒng)的解決問題。 ? Handle CR (change) for machine improvement and optimization. When there’re machine issues occur such as production risk, high scrap rate, machine down time caused by design, unreasonable method，the responsible engineer will seek for machine improvement and optimization method through contacting supplier of OEM supplier. When doing this required CR, support to finalize CR case to handle the whole process from the beginning to the end of machine update. 處理變動以改進和優(yōu)化設備。當設備發(fā)生問題時，如：生產(chǎn)風險、廢品率升高、停機、不合理的方法， 維修工程師要與設備供應商一起尋找改進和優(yōu)化的方法。 ? Participate in new project and new machine introduction at the early beginning of project of new machine. Participate in design review and test review so that some error can be found earlier. Execute test and validation. 參與新項目和新設備引進；審核設計和測試方案盡早發(fā)現(xiàn)問題；執(zhí)行設備測試和驗證。 ? Operate SAP PM& MM system to support maintenance work and spare parts management, open and close work order. 操作SAP系統(tǒng)，支持日常維修工作以及備件管理，處理系統(tǒng)工作訂單。 ? Ensure all maintenance activities are done according to SOP, passing all internal and external audits without any findings about SOP compliance. 確保所有維修活動按照SOP執(zhí)行，符合質(zhì)量要求，通過內(nèi)、外部審計。 ? Make sure all maintenance activities are in compliance with safety, production or quality requirements or standard. 確保所有的維修活動合規(guī)，符合生產(chǎn)、安全、質(zhì)量的要求。 ? Participate in validation, technology transfer and process improvements including: 參與驗證活動、技術轉(zhuǎn)移和工藝改進： o Ensure validation and verification of processes, machines and equipment. 確保對工藝流程、機器設備的檢查和驗證的實施 o Responsible for event response and NC handling during validation. 解決驗證期間發(fā)現(xiàn)的問題和偏差事件 o Prepare ，review and approve validation documentation and share best practice for validation with relevant stakeholders. 準備，審核并批準驗證文件，分享實踐方法 o Escalate problem according to escalation procedure. 按照流程上報問題