(高级）自动化工程师

工作目的

1. 01

   负责自控系统的设计、FAT、SAT、安装调试、验收确认方面的工作，包括技术文件审核和验证确认文件编写，现场安装调试协调及验证确认执行，竣工图纸及PLC&HMI程序审核、备份，运行维护SOP/WI编写等； Be responsible for automation system deployment through design to

&acceptance including technical dossier and qualification dossier review, hardware installation monitoring, commissioning&qualification execution, as-built drawing review, program review&archive and operation SOP/WI drafting.

2. 02

   按要求落实维护维修工作，确保所负责的自控系统运行稳定可靠； Implement PM&CM according to SOP/WI and ensure automation system running smoothly.

3. 03

   确保所负责的自控系统在权限管理、审计追踪、数据备份等功能方面符合数据完整性的要求； Ensure owned system be in compliance with DI requirements regarding authorization, audittrail, data backup etc functions.

4. 04

   基于风险的备品备件管理，确保关键备件安全库存； Risk-based spare parts management and ensure safety inventory for key spare parts.

5. 05

   负责自控系统改进改造，包括所有硬件升级、更换以及控制程序修正，持续提高系统稳定、合规性。 Be responsible for automation system modification&improvement to enhance system reliable and compliance. 主要工作内容：

6. 01

   持续提高自控系统的稳定性和合规性，确保满足生产与质量需求； Continue to enhance automation system stability and compliance to meet the requirements of manufacturing & quality assurance.

7. 02

   负责自控专业技术文件和验证确认文件审核, 现场安装调试协调，FAT/SAT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 technical dossier and qualification dossier review, installation&commissioning coordination, FAT/SAT/Qualification execution, as-built drawing and program review&archive.

8. 03

   负责设施设备的自控系统运行维护、故障处理、改进改造工作； Be responsible for maintenance, troub-shooting, modification work for utility & equipment automation system.

9. 04

   自控专业有关的备品备件管理； Be responsible for spare parts management of automation system.

10. 05

    参与设施设备变更、偏差及年度回顾，并负责自控技术有关的工作； Participant in changes, deviations and annual reviews work and be incharge of related part associate with automation discipline.

11. 07

    自控系统偏差与变更处理，包括的偏差调查、影响评估、CAPA制定与实施跟踪； Be responsible for automation system change control and deviation including investigation, impact assessment, CAPA developping & implementation.

12. 08

    自控系统周期性回顾和再确认工作； Periodic review and requalification for automation system.

13. 09

    完成上级主管安排的其他工作。 Others assigned by supervisor. 学历要求： 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 related discipline such as electrical control, instruments automation etc. 工作经验： 1.5+年制药工厂自控系统运行维护经验； Minimum of 5 years automation system operatoin&maintenance experience at pharma plant.

14. 02

    有口服固体制剂生产设备自控系统的安装、调试、验证确认、维护经验； Possess related experiences in automation system installation, C&Q and maintenance regarding OSD equipment.

15. 03

    熟悉数据完整性对于自控系统的要求, 能够采取有效的预防措施，确保计算机化系统的数据完整性； Be familiar with DI requirements to computerized system, can take effective precautions to keep DI compliance of computerized system.

16. 04

    能够独立解决自控系统常见故障，包括硬件更换、程序修改； Trouble-shooting independently for automation system, includes hardware replace/configuration, program update.

17. 05

    有NDA/PAI/GMP（含FDA或EU）符合性审核相关的经验； Successful experience in passing NDA/PAI/GMP (including FDA or EU) compliance audits.

18. 06

    熟悉主要生产设备或关键公用系统（HVAC, PW）工艺原理优先。 It's preferred for be familiar with process principle of production equipment or utility system(HVAC & PW). 技能要求：

19. 01

    熟悉OSD制药工厂设施设备的自动化系统，如制粒、流化床、压片、包衣、胶囊充填及铝塑或瓶包装线、PW、HVAC的自控系统。 Be familiar with automation control system of utility/equipment in OSD manufacturing plant, such as gruanulation, tablet compression, coating, fluid bed, blister/botter packaging line, PW and HVAC etc.

20. 02

    精通Simens Simatic系统，包括PLC-1200/1500，HMI等硬件和TIA编程软件（博途）的使用，能够独立完成组态、编程、故障查找。 Be skilled in Simens Simatic automation products such as PLC 1200/1500, HMI etc hardware, and can use TIA Portal software to perform hardware configuration, software programing and troubleshooting.

21. 03

    熟悉不同的通讯协议Modbus、Profinet、BACnet等集成方案。 Be familiar with system integration solutions of different communication protocols such as Modbus、Profinet and BACnet ect.

22. 04

    熟悉自控系统的现场传感器、执行部件的安装调试，例如流量计、温湿度变送器、压差计、控制阀等，并能处理相关故障。 Be familiar with installation and commissioning for on-site instruments/transmitter and actuator of automatic control system , such as flow meters, temperature and humidity, differential pressure, control valves, and be able to handle related faults.

23. 05

    熟悉计算机化系统的调试验证流程，能够独立编写验证方案和验证报告。 Be familiar with qualification for CS and can complie qualificaiton protocol&report independently.

24. 07

    熟悉ISPE, PDA, PIC/S,WHO, FDA, NMPA等法规/指南对计算机化系统合规运行的有关要求。 Be familiar with related regulation regarding computerized system compliance operation required by ISPE,PDA,PIC/S,WHO,FDA,NMPA etc.

25. 08

    了解BMS\EMS\SCADA\DCS等自控系统。 Be familiar with BMS/EMS/SCADA/DCS etc.

26. 09

    良好的逻辑分析能力以及团队协作精神。 Good logical-based analysis thinking and team working spirit. 语言和电脑知识：

27. 01

    熟悉 office 软件以及 CAD, E-PLAN 等专业软件的使用 Be familiar with office soft package and professional soft of CAD and E-PLAN

28. 02

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