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(chǎn)流程知識的專業(yè)人員，良好的 掌握自動化生產(chǎn)流程相關(guān)應(yīng)用例如MES (PAS-X), LES,PCS7, Historian (OSI PI) and OEE (TrackSys) ，追溯系統(tǒng)，并能夠?qū)⑾到y(tǒng)知識通過合理的分級培訓(xùn)轉(zhuǎn)移給到業(yè)務(wù)團隊。自動化工程師能夠獨立與IT 業(yè)務(wù)分析員和 全球 業(yè)務(wù)分析員進行定期溝通， 并負責(zé)將問題的后續(xù)解決方案與影響與業(yè)務(wù)達成良好溝通。針對常見設(shè)計問題，能夠獨立提出相關(guān)解決方案。 項目建設(shè)期間參與項目前期的設(shè)計，建造，調(diào)試和確認等工作，作為用戶代表更好的支持項目組實現(xiàn)青島pMDI工廠的建設(shè)。進入商業(yè)化生產(chǎn)期間，在遵守安全、GMP的前提下,正確、有效的執(zhí)行自動化系統(tǒng)應(yīng)用的改進、維護活動，快速響應(yīng)現(xiàn)場報修需求，確保所有自動化系統(tǒng)處于安全和高效率的運行狀態(tài)，以支持pMDI工廠生產(chǎn)及供應(yīng)的核心業(yè)務(wù)流程,達成領(lǐng)先的SQSCP的績效。同時不斷提高技術(shù)能力，就自動化應(yīng)用方面的問題與內(nèi)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(tǒng)層面生產(chǎn)流程Production process? system view * 與配料、制劑、罐裝、組裝、包裝的流程執(zhí)行一線經(jīng)理和專家以及項目組來總結(jié)和可視化現(xiàn)行的生產(chǎn)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(jù)藥品生產(chǎn)質(zhì)量管理規(guī)范和PAS-X可執(zhí)行批生產(chǎn)記錄的理念將生產(chǎn)流程進行系統(tǒng)語言轉(zhuǎn)化,并能實現(xiàn)流程的簡化以及標(biāo)準(zhǔn)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(zhí)行團隊一起共同推進PAS-X系統(tǒng)，以使工廠實現(xiàn)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(zhí)行團隊一起共同推進過程控制系統(tǒng)如PCS7，以實現(xiàn)青島工廠制劑工藝的穩(wěn)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(zhí)行團隊一起共同推進追溯系統(tǒng)，以實現(xiàn)青島工廠產(chǎn)品的可追溯性Lead PET to roll out traceability system to enable traceability of Qingdao site products * 與流程執(zhí)行團隊一起共同推進自動化系統(tǒng)的應(yīng)用, 比如LES、大數(shù)據(jù)課題Data Historian &? Discoverant以及質(zhì)量系統(tǒng)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(shù)字自動化系統(tǒng)方面的SOP和工作指導(dǎo)文檔并持續(xù)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(chǎn)運營Operation * 負責(zé)自動化軟件的管理、預(yù)防性/故障維護活動，并根據(jù)GMP,CGMP,SHE和生產(chǎn)的要去對自動化程序進行開發(fā)和維護：Responsible for automation software management 、preventive /restorative maintenance activities, * 負責(zé)自動化軟件及設(shè)施的管理和維護Responsible for the management and maintenance of automation software and facilities負責(zé)自動化系統(tǒng)的升級和改進Responsible for the upgrade and improvement of the automation system * 對設(shè)備運行進行優(yōu)化，以提高生產(chǎn)力和穩(wěn)定性O(shè)ptimize equipment operation to improve productivity and stability * 對新項目新設(shè)備進行研究，編寫相關(guān)的材料（用戶需求、規(guī)格說明書）Research on new projects and new equipment, and prepare relevant materials (user, specifications)負責(zé)自動化程序的備份Responsible for the backup of the automated program * 參與或領(lǐng)導(dǎo)新的項目，提出推薦方案，實施解決方案，以確保項目達成預(yù)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(dǎo)Write SOPs and work instructions for automated programs * 通過培訓(xùn)分享提高團隊的技能Improve the team's skills through training and sharingGMP/合規(guī)/SHE相關(guān)責(zé)任Responsibility forGMP/Compliance/SHE * 在進行一切與業(yè)務(wù)相關(guān)活動時都嚴(yán)格遵守公司 GMP、SHE、合規(guī)及其與職位和職責(zé)相關(guān)的支持性政策與標(biāo)準(zhǔn)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(chǎn)負責(zé)人/流程團隊成員緊密協(xié)調(diào)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(jīng)驗，能夠基于精益原則和工具實踐精益和問題解決并持續(xù)改善Requiremets * 工程/自動化/計算機領(lǐng)域的本科或以上學(xué)歷Bachelor or above degree, major degree in engineering * 5年信息自動化領(lǐng)域經(jīng)驗5 years’ experience in IT automation field * 5年跨國制藥企業(yè)自控工作經(jīng)驗5 years automation experience in multinational pharmaceutical company * 具有項目或者新工廠啟動相關(guān)的工作經(jīng)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(shè)計的經(jīng)驗以及系統(tǒng)問題解決經(jīng)驗Good experience of LES designing or problem solving * 具備Historian (OSI PI)設(shè)計的經(jīng)驗以及系統(tǒng)問題解決經(jīng)驗Good experience Historian (OSI PI) of designing or problem solving
