工作职责：

1. 负责OT数据网络的设计文件的审核优化和URS的编制，以及安装、调试、验证、交付全项目管理流程；

Responsible for the review and optimization of the design documents of the OT data network and the preparation of URS, as well as the entire project management process of installation, commissioning, validation and delivery.

2. 负责计算机化系统验证CSV的方案及报告的审核，协调推进CSV的实施；

Responsible for reviewing the computerized system validation (CSV) protocol and report, and coordinating and promoting the implementation of CSV.

3. 负责OT系统的GMP合规性审核，确保终端设备的数据真实性和完整性；

Responsible for the GMP compliance review of the OT system to ensure the authenticity and integrity of the data of the terminal equipment.

4. 负责自控承包商的管理工作，监督其建设阶段的质量、安全和进度保证；

Responsible for the management of automation contractors and supervising their quality, safety and time schedule during the construction phase.

5. 负责起草各个自控系统的SOP文件，保障系统在验证后的顺利交付使用。并需符合现有上海工厂的计算机化系统管理、网络安全管理、EHS管理、和其他财务及审计相关的规定，需起草包括但不限于如下SOP：IT基础架构管理、空调自控计算机化系统操作管理、EMS系统操作管理、LIMS系统操作管理、WMS系统操作管理、MES系统操作管理、计算机化系统验证、电子记录电子签名管理、以及各设备的自控部分操作管理等；

Responsible for drafting SOP documents for each automatic control system to ensure the smooth delivery of the system after validation. And the SOPs must comply with the existing regulations of the computerized system management, network security management, EHS management, and other financial and auditing related the DS Shanghai factory, including but not limited to the following SOPs: IT infrastructure management, air conditioning automatic control computerized system operation management, EMS system operation management, LIMS system operation management, WMS system operation management, MES system operation management, computerized system validation management, electronic records and electronic signatures management, and the part of automatic control of each process equipment, etc.

6. 负责自控系统软硬件及仪表的选型。

Responsible for the selection of software, hardware and instruments for the automation system.

1.本科及以上，自动化相关专业。

Bachelor degree or above, automation related major.

2.至少从事生物制药工厂相关工作五年以上，负责过生物制药新建厂房中的自控系统建设。

At least 5 years of related experience in the field of biopharmaceutical factory. And have been responsible for the construction of the automation system in a newly built biopharmaceutical factory.

3.良好的英语或日语口语及书写能力。

Good written and oral communication skills in English or Japanese.

4.具备较强的组织协调能力和项目沟通能力；

Have strong organizational coordination and project communication skills.

5.熟悉DCS/SCADA/WCS/PLC等控制软件；

Familiar with DCS/SCADA/WCS/PLC and other control software.

6.熟悉GB50174，GAMP5，21 CFR PART11等规范；

Familiar with GB50174, GAMP5, 21 CFR PART11 and other standards.

7.熟悉计算机化验证CSV的流程；

Familiar with the process of computerized system validation.

8.了解生物制药相关生产工艺，有诸如MES/WMS/LIMS/QMS相关的工作经验；

Understand biopharmaceutical manufacturing processes, and have relevant work experience such as MES/WMS/LIMS/QMS.

9.精通办公软件和项目软件。

Proficient in the use of office software and project software.