Automation manager

Job Purpose/工作目的 1.自控系统有关的新建、改造项目管理，确保交付可靠、合规及功能完善的自控系统，主要工作包括系统技术方案制定、技术文件审核、FAT、SAT、现场安装协调和C&Q方面的工作。 Be responbile for Automation system project management, ensure to deliver reliability, compliance and full function system, main tasks includes developping technical proposal, review technical dossiers, FAT&SAT, site installation/construction management and C&Q. 2.自控项目竣工资料审核，包括竣工图纸、硬件安装维护手册、PLC&HMI程序审核、备份等，确保资料完整。 Be responsible for the as-built dossier review including drawing, manual and PLC&HMI program review to ensure as-built dossier integrated. 3.确保工厂自动化控制系统（包括生产工艺设备和公用设备的自控系统）的运行稳定性、合规性，以及满足数据完整性和计算机化系统合规方面的要求，支持生产连续运行。 To ensure site automation system(includes process equipment and utility equipment) stability and compliance, and meet the requirements regarding DI, CS compliance. 4.基于内外部合规管理、法规驱动，审计发现项的纠正与预防需要，持续改进优化工厂自动化控制系统，提高运行稳定性、效率及合规性。 with the driving of internal/external compliance demands and CAPA needs, continue to improve the stability, compliance and efficiency of site automation system. 5.对工厂自动化控制系统管理层、控制层、执行层的所有软件、硬件开展定期检查维护、升级以及程序修正等工作，确保系统可靠、合规。 Be responsible for periodic check and preventive maintenance for site automation system inlcudes all of components of the different level to ensure system reliable and compliance. Main Responsibilities/主要职责 1.确保工厂工艺设备和公用设施自控系统的稳定性和合规性。 To enhance stability and compliance of automation system of process equipment and utility system. 2.负责项目（包括厂房新建、扩建，设施设备引进、扩容、改造等）自控专业相关工作，包括技术文件和验证确认文件审核、现场安装调试及验证确认执行、竣工图纸及PLC&HMI程序审核备份等 Be responsible for automation control system management of any projects, including technical dossier and qualification dossier review, hardware installation monitoring, commissioning&qualification execution, as-built drawing and program review&archive. 3.负责生产工艺设备/生产线和公用设施的自控系统日常管理，包括运行维护、故障处理、升级改造等事项，确保自控系统运行可靠、合规。自控系统包括不限于混合机、制粒机，压片机、流化床、包衣机、胶囊充填机、泡罩包装线、瓶包装线、BMS、EMS、PW、WFI、WWT、Chilling/colling water等设备/系统的自控部分。 Be responsible for preventive maintenance for automation system of process equipment and utility equipment ensuring automation system running with high reliability, compliance. 4.前述系统自控专业有关的备品备件管理，基于风险识别关键备件并确保有效的安全库存。 Be responsible for spare parts management for above automation system, key spare parts indentification base on risk analysis and keep safety inventory. 5.作为自控系统负责人，与生产工艺设备负责人、公用系统负责人和计算机化系统验证人员密切合作确保计算机化系统在项目阶段和运维阶段的高度合规性。 As automation sysetem owner,closely working together with process equipment owner, utility system owner and computerized system QA to ensure computerized system compliance strictly. 6.推动工厂自控系统的改进优化工作，以响应不断变化的法规要求以及工业数字化、智能化的要求。 To Drive the improvement and optimization for automation system in response to the trend of industrial digitization and AI . 7.负责起草自控系统SOP文件，并对操作人员进行有效培训，保障系统在验证交付后的顺利使用。 Be responsible for SOP drafting and updating and carry out effective training to operator, escort for routine operation after go-live. 8.执行自控系统有关的变更、偏差及年度回顾、再确认等相关工作. Be responsible for process of change, deviation, periodic review and requalification work to automation system. 9.计算机化系统相关的年度回顾、再确认，以及偏差/变更的起草、调查、影响评估、及措施的实施跟踪。 Be responsible for automation system periodic review, re-qualification and Chang control & deviation investigation, impact assessment, CAPA implementation etc. 10. 开展技术培训，提高团队人员解决自控系统故障的能力和计算机化系统合规的技术能力。 Conduct professional training to enhancing team member's capability of automation troubleshooting skills and computerized systems compliance. 11. 完成上级主管安排的其他工作。 Complete the tasks assigned by supervisor. 教育背景： 本科或以上学历，电气控制、仪表自动化等相关专业 Bachelor or above degree , majored in automation related such as electrical control, instruments automation etc. 技术技能要求： 1. 熟悉制药工厂常见的自动化系统，如 Siemens PCS7/EmersonDeltaV/Wonderware DCS,SCADA，EMS, BMS, DHS等系统 Be familiar with automation control platform of phamar plant, such as Siemens PCS7/EmersonDeltaV/Wonderware DCS,SCADA,BMS, EMS, DHS etc. 2. 精通Simens自控系统，包括PLC，变频器等硬件选型配置和TIA编程软件（博途）的使用，能够独立完成组态、编程、查找故障。 Be skilled in Simens automation products such as PLC, frequency invert configuration and TIA Portal software operation etc. Can perform hardware configuration, software programing and troubleshooting. 3. 熟练使用WinCC/WinCC flexible编程软件，能够编程组态。 Be skilled in WinCC/WinCC flexible software and can do programming & configuration. 4. 熟悉不同的通讯协议Modbus、Profinet、BACnet等系统集成方案。 Be familiar with system integration solutions of different communication protocols such as Modbus、Profinet and BACnet .,ect. 5. 熟悉自控系统的现场仪表和执行部件，例如流量计、温湿度仪、压差计、控制阀等，并能处理相关故障。具有仪表计量相关知识。 Be familiar with instruments/transmittor and actuator of automatic control system , such as flow meters, temperature and humidity, differential pressure, control valves etc, and be able to handle related faults. Have relevant calibration knowledge. 6. 熟悉药厂自控系统调试与确认流程，能够独立编写验证方案和验证报告。 Be familiar with automation system C&Q in pharma industry and can complie qualificaiton protocol&report independently. 7. 熟悉口服固体制药工厂主要工艺设备的组成及其工艺原理，如制粒、压片、包衣，胶囊充填，流化床，泡罩内包、瓶内包线等。 Be skilled in components and operation principle regarding OSD production equipment such as tablet compression machine, coating machine, fluid bed, capsule filling machine, blister and bottle primary package line etc. 8. 熟悉工艺设备自控系统和BMS\EMS系统，以及其维护工作。 Be familiar with automation control system of process equipment&BMS/EMS and maintenance. 9. 熟悉ISPE GAMP5, PDA, PIC/S,WHO, FDA, NMPA等法规/指南对计算机化系统设计、安装、调试验证、运行管理有关的要求。 Be familiar with related regulation requirements from ISPE GAMP5,PDA,PIC/S,WHO,FDA,NMPA to computerized system regarding design, installation,C&Q and routine maintenance 10. 了解ISA-95企业控制系统架构集成 Knowledges about enterprise control system integration. 11. 具备较强的组织协调能力和沟通能力，良好的团队协作精神。 Has strong organization,coordination and communication skill, and good team working spirit. 工作经验： 1.10+年MNC药厂自控系统项目管理和运行维护经验, 3+年带团队经验。 Minimum of 10 years automation system operatoin&maintenance experience and 3+ team leader experience at MNC pharma plant. 2.有独立负责DCS/SCADA等较大自控系统项目经验，作为项目负责人成功落实设计、安装、调试、验证确认工作。 Has project experience of DCS/SCADA etc large scale automation system as leader to implement design, installation, commissioning and qualification. 3.具备药厂自控系统的运行管理经验, 能够预测风险并采取有效的预防措施，确保计算机化系统运行稳定、合规，确保数据完整性。 Solid experience for operation management of automation system, can foresee potential risk and take effective precautions to ensure automation system in compliance with c.GMP regulation and data integrity. 4.能够独立解决自控系统故障，包括硬件更换、程序修改. Trouble-shooting independently for automation system, includes hardware replace/configuration, program debug. 5.作为工厂自控系统负责人或SME，深度参与过NDA/BLA/PAI及GMP合规性（NMPA,FDA或EU）相关的审计。 As site automation system owner or SME, has successful experience in NDA/BLA/PAI and GMP compliance audit (NMPA,FDA or EU). 6. 熟悉Honeywell，Rockwell自控产品； Be familiar with Honeywell, Rockwell Automation products; 7.有药厂生产制造管理系统（如MES\LIMS\WMS\DHS等）部署经验者优先。 Deployment experience for manufacturing OT systems (such as MES, LIMS, DHS, etc.) is preferred. 语言能力&电脑知识： 1.精通office软件以及熟悉Project，CAD, E-PLAN等专业软件的使用 Be familiar with office soft package and professional soft of Project, CAD and E-PLAN 2.良好的英语书面和口语能力。 Good English in both written and oral skill. 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. ●Fosters Teamwork ●Provides and Solicits Honest and Actionable Feedback ●Self-Awareness ●Acts Inclusively ●Demonstrates Initiative ●Entrepreneurial Mindset ●Continuous Learning ●Embraces Change ●Results-Oriented ●Analytical Thinking/Data Analysis ●Financial Excellence ●Communicates with Clarity 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. 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