04 Jul, 2022

Process Automation Engineer

  • Thermo Fisher Scientific
  • Hangzhou, Zhejiang, China
Lead Engineer, Process Engineer Biochemicals / Pharmaceuticals

Job Description

Purpose of the Position*

岗位目标*

Provide engineering support to CAPEX engineering & technical projects related with DS&DP production process computerized process equipment (CU equipment) including but not limited single chip machine, PLC/DCS, HMI, SCADA and MES .

为Capital原液和制剂生产工艺计算机化工艺设备项目(公用洁净系统)提供工程技术支持包含但不限于单片机,可编程逻辑控制器/分布式控制系统、触摸屏,SCADA以及制造执行系统。

Primary work load as automation SME focuses on process equipment’s FS, HDS and SDS review and approve to make sure the equipment running under control within the FS description duration the equipment life cycle.

作为自动化SME首要工作专注于工艺设备功能设计,硬件设计以及软件设计的检阅与批准,同时确保工艺设备在生命周期中依据功能描述的功能执行。

Make sure the electronic record and e-signature of each process equipment generated in upstream or downstream are data integrity, appropriate and trackable and fulfill the FDA 21 part11 regulation.

确保每台工艺设备所生成的电子记录与电子签名数据完整性,准确性以及可追述性,同时要完全满足FDA21 part11法规要求。

Propose the computerized system strategy of access control, time synchronization, alarm management net architecture, data backup and restore, system disaster recovery and so on for process equipment.

提出工艺设备计算机化策略包含权限控制、时间同步、报警管理、网络架构设计、数据备份与恢复、系统灾难恢复等。

Make sure the automation system for process equipment control should be developed and verified in accordance with GAMP5 (A Risk Based Approach to Compliant GxP Computerized Systems).

确保工艺设备自动化控制系统应按照GAMP5(遵从GxP计算机化系统监管的风险管理方法)进行开发和验证。

Make sure the process equipment can be readable or writeable by 3rd partner software through the universal communication protocol to ensure the future software extension and integrity in high level.

确保工艺设备能够通过公用的通讯协议被其它软件读取满足更高层次软件扩展与集成。

Provide technical lead in the development of specifications (URS and so on) for automation or computerize equipment / systems.

对自动化或者计算机化系统与设备技术开发中,提供技术专家的支持。

Write, approve, and train personnel on related SOPs (standard operation procedures). Support change control, CAPA, and operations initiatives on behalf of site process automation expert

撰写、批准相关的SOP,以及对相关人员进行培训。作为SME参与变更控制、CAPA以及运营相关活动。

Coordinate, aid and develop preventive maintenance procedures related with computerized system.

协调、组织与设计计算机化系统预防性维护策略

Other duties assigned by leader or manager

其他被指定的任务。


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