職位描述
Summary崗位工作地點在青島。自動化工程師是具備良好生產流程知識的專業人員，良好的 掌握自動化生產流程相關應用例如MES (PAS-X), LES,PCS7, Historian (OSI PI) and OEE (TrackSys) ，追溯系統，并能夠將系統知識通過合理的分級培訓轉移給到業務團隊。自動化工程師能夠獨立與IT 業務分析員和 全球 業務分析員進行定期溝通， 并負責將問題的后續解決方案與影響與業務達成良好溝通。針對常見設計問題，能夠獨立提出相關解決方案。 項目建設期間參與項目前期的設計，建造，調試和確認等工作，作為用戶代表更好的支持項目組實現青島pMDI工廠的建設。進入商業化生產期間，在遵守安全、GMP的前提下,正確、有效的執行自動化系統應用的改進、維護活動，快速響應現場報修需求，確保所有自動化系統處于安全和高效率的運行狀態，以支持pMDI工廠生產及供應的核心業務流程,達成領先的SQSCP的績效。同時不斷提高技術能力，就自動化應用方面的問題與內部和外部客戶建立高效的溝通。This role is based in Qingdao and qualified production process knowledgeable person mastering good skills of MES (PAS-X), LES, PCS 7,Historian (OSI PI) and OEE (TrackSys), Traceability system，also has the capability to transit the knowledge to BAU team through appropriate training delivery. The role also be capable of hosting the regular discussion with global IT BA and global GMBR expert for issue tracking and solution.? And be able to deliver a good communication with business of the issue’s solution and impact. During project phase involved in project Design、Construction、Commissioning and Qualification? as end user to support Global engineering team/Project team to deliver Qingdao pMDI project.When moving into BAU, To comply SHE and GMP，through appropriate automation system update 、maintenance activities effectively ,quick response to trouble-shooting ,make sure all the automation application system in safe, high-yield manner to support the core business process of pMDI site to achieve top decile performance of SQSCP. Improve the professional capability constantly, communicate with external and internal customer and supplier for automationResponsibilities系統層面生產流程Production process? system view * 與配料、制劑、罐裝、組裝、包裝的流程執行一線經理和專家以及項目組來總結和可視化現行的生產流程Work together with ?dispensing、formulation、filling、A&P ?process facilitators and SME and project member to summarize and visualize the current production process. * 根據藥品生產質量管理規范和PAS-X可執行批生產記錄的理念將生產流程進行系統語言轉化,并能實現流程的簡化以及標準化。Transfer the production process based on GMP requirements and PAS-X MBR design concept into system design especially in the way of simplification and standardization. * 與流程執行團隊一起共同推進PAS-X系統，以使工廠實現電子批記錄和物料追蹤Lead PET to roll out PAS-X system to enable Qingdao site EBR/material flow tracking. * 與流程執行團隊一起共同推進過程控制系統如PCS7，以實現青島工廠制劑工藝的穩定運行Lead PET to roll out process control system like PCS7 to enable formulation process of Qingdao site run steadily * 與流程執行團隊一起共同推進追溯系統，以實現青島工廠產品的可追溯性Lead PET to roll out traceability system to enable traceability of Qingdao site products * 與流程執行團隊一起共同推進自動化系統的應用, 比如LES、大數據課題Data Historian &? Discoverant以及質量系統等。Can take some sub-stream project tracking responsibilities i.e. ?LES Big ?data related-Data Historian & Discover ant and Quality system etc… * 撰寫數字自動化系統方面的SOP和工作指導文檔并持續確保最新的版本給到用戶Draft digital & automation system documents such as SOP 、WI and continuously ensure the latest effective version to all of users生產運營Operation * 負責自動化軟件的管理、預防性/故障維護活動，并根據GMP,CGMP,SHE和生產的要去對自動化程序進行開發和維護：Responsible for automation software management 、preventive /restorative maintenance activities, * 負責自動化軟件及設施的管理和維護Responsible for the management and maintenance of automation software and facilities負責自動化系統的升級和改進Responsible for the upgrade and improvement of the automation system * 對設備運行進行優化，以提高生產力和穩定性Optimize equipment operation to improve productivity and stability * 對新項目新設備進行研究，編寫相關的材料（用戶需求、規格說明書）Research on new projects and new equipment, and prepare relevant materials (user, specifications)負責自動化程序的備份Responsible for the backup of the automated program * 參與或領導新的項目，提出推薦方案，實施解決方案，以確保項目達成預期Participate in or lead new projects, propose proposals, and implement solutions to ensure that the project meets expectations * 編寫自動化程序的SOP和工作指導Write SOPs and work instructions for automated programs * 通過培訓分享提高團隊的技能Improve the team's skills through training and sharingGMP/合規/SHE相關責任Responsibility forGMP/Compliance/SHE * 在進行一切與業務相關活動時都嚴格遵守公司 GMP、SHE、合規及其與職位和職責相關的支持性政策與標準Conduct all business activities in compliance with the GMP /SHE/Compliance supporting Policies and Standards related to position and responsibilities * 日常工作中與帶班/生產負責人/流程團隊成員緊密協調Well coordinate with group leader/PF/PCO members in daily operationLean/PPS精益和實踐問題解決 * Have great lean mindset and have good practice to embed PPS into business case and needs * 具有精益尤其PPS理念和經驗，能夠基于精益原則和工具實踐精益和問題解決并持續改善Requiremets * 工程/自動化/計算機領域的本科或以上學歷Bachelor or above degree, major degree in engineering * 5年信息自動化領域經驗5 years’ experience in IT automation field * 5年跨國制藥企業自控工作經驗5 years automation experience in multinational pharmaceutical company * 具有項目或者新工廠啟動相關的工作經驗Have project or new site startup related experience * 能夠熟練的進行英語讀說Reading and speak English very well * 具備LES設計的經驗以及系統問題解決經驗Good experience of LES designing or problem solving * 具備Historian (OSI PI)設計的經驗以及系統問題解決經驗Good experience Historian (OSI PI) of designing or problem solving
