04 Jul, 2022

Process Automation Engineer

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

Job Description

Purpose of the Position*


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 .


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.


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.


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).


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.


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


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


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


Other duties assigned by leader or manager


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