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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或以上學歷 ? Education or training in GMP and LEAN. 接受過GMP規則和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專業經驗: ? Minimum 3-5 years of working experience in manufacturing factory. Prefer clean room or aseptic area experience. 兩年以上生產制造企業工作經驗，最好有無菌環境的經驗。 ? Experience of equipment maintenance in aseptic process of cGMP regulated pharmaceutical industry. cGMP規范的制藥廠無菌生產流程的設備維護經驗。 ? 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. 具備如下系統的專業知識：氣動系統，公用工程，儀表，動力控制，SAP系統。 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行生產設備維修工作，確保無菌生產設備穩定高效地運行。處理設備問題，執行設備改進和優化，以確保工作流程符合安全、生產、質量以及標準的要求。 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的要求執行生產設備日常維修保養和定期檢修，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. 保證生產按計劃執行，與生產團隊良好溝通以確保設備維修活動不影響生產。 ? 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，調查問題的根本原因，與生產團隊和工藝支持團隊一起合作運用精益生產的工具系統的解決問題。 ? 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化設備。當設備發生問題時，如：生產風險、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現問題；執行設備測試和驗證。 ? Operate SAP PM& MM system to support maintenance work and spare parts management, open and close work order. 操作SAP系統，支持日常維修工作以及備件管理，處理系統工作訂單。 ? 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執行，符合質量要求，通過內、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，符合生產、安全、質量的要求。 ? Participate in validation, technology transfer and process improvements including: 參與驗證活動、技術轉移和工藝改進： 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. 解決驗證期間發現的問題和偏差事件 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