Process Engineer IV

Category:  Engineering

Tianjin, Tianjin, CN


Key areas of responsibility 主要工作职责:

Process engineer is responsible for compliance of daily production activities that to ensure quality and efficiency of production. Work according to GMP, GDP and SOP. Ensure NC, CR, PSE, QAP, validation are accomplished within schedule, and OEE, scrape rate are meet the KPI.



Main Job Tasks 主要工作任务:

  • Be the process owner of appointed production line.
  • 担任指定生产线的工艺负责人。
  • Ensure the stability of process, production line and system.
  • 保证工艺流程、生产线设备和系统运行稳定:

o Increase the stability of the equipment/systems performance by reducing variations.


o Identify best practices for work processes and make sure they are anchored in the relevant



o Continuously improve corrective maintenance and preventive maintenance base on the statistical data . 依据统计数据持续改进纠正维修和预防维修工作流程。

  • Optimize existing process: 优化改进现有工作流程:

o Continuously look for improvement and be seen to think out of the box on manufacturing technologies. 在生产制造技术的基础上扩大眼界和思路,持续发觉改进工艺流程的机会。

o Constantly ensure to decrease scrap and increase production efficiency from processes through implementation of Kaizen ideas and PIP projects. 通过改善项目的执行不断地提高生产效率、降低废品率。

o Implementation of changes to improve process. Handling of change requests in relation to changes.执行变更,改善工艺,处理变更(CR)。

o Lead and drive engineering activities for operational excellence.

  • Trouble shooting on complex technical issues. 解决复杂的技术问题:

o Lead root-cause investigation of production issues. 主导生产问题原因调查。

o Actively engage in solving deviations. 处理偏差。

o Apply systematic problem solving tools to daily trouble shooting, drive the follow-up on the problem solving. 用系统化解决问题的方法解决问题并跟踪进展情况。

  • Validation of process and equipment. 执行工艺流程和生产设备验证:

o Plan and perform validation activities, includes initiate CR, draft validation document, plan test until hand over to production successfully. 计划并实施验证活动:启动CR、撰写验证文件、计划并实施测试直到交付生产实施。

o Evaluation process periodically and maintain validation status. 定期执行工艺流程评估,维护验证状态。

o Ensure all validation activities are in compliance with GMP and NN requirements. 确保所有验证活动遵循GMPNN要求执行。

  • Set up and develop standards for processes and equipment. 建立工艺流程和设备的标准:

o Implement and develop already existing standards where available. 执行并开发现有标准。

o Create new standards where needed. 建立新标准。

  • Participate in process related projects. Ensure all projects are governed and implemented according to NN PPM model. 参与工艺相关项目,保证项目的管理和实施遵循NN项目管理方法。
  • Ready for travel at any time according to business needs. 能够根据业务需要随时出差


Education Background: 教育背景

  • Bachelor or Master Degree in manufacturing engineering or similar education background.
  • 制造工程或相关学科领域大学本科及以上学历
  • Education/training of GMP regulation, validation,
  • LEAN and statistics is preferable.
  • 最好接受过GMP、验证、精益管理、统计的培训。
  • Fluent in written and reading English.
  • 流利的英语听说技能。

Professional Experience专业经验:

  • Minim 4-6 years of relevant working experience.
  • 至少4-6年相关工作经验。
  • Experience in automation and mechanical areas.
  • 机械、自动化领工作经验。
  • Experience of working in a production environment with highly automated machines.
  • 在高度自动化设备生产环境的工作经验。
  • Experience of GMP/ISO 9001/ISO 13485 regulated production, validation and change procedures. GMPISO9001ISO13485标准化要求的生产、验证、变更管理流程的工作经验。


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At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.