Process Engineer III

1 month ago

Tianjin, China Novo Nordisk Full time

   

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.

 

The position       

Key areas of responsibility:     

  1. Be the owner of appointed production machine/equipment.                                                  担当指定生产设备的负责人。

 

  1. All actions with deadline should be finished on time, that include Q case, DV, CR, OPV/SE, VSS, etc.   按时完成Q case、DV、CR、OPV/SE、VSS等工作任务。

 

  1. Set up metrology specification and ensure calibration meet MPE requirement. Execute machine software backup verification, machine test relevant to investigation or validation.                                     建立测量说明书并校准设备，以确保符合最大允许误差的要求。执行验证相关设备软件备份检查和设备测试。
  2. Execute process validation when machine rebuilding happened.                                             设备重建时进行验证。

 

  1. Periodically review logbook according to requirement.                                                       按照规定定期检查日志文件。

 

  1. Update and archive all relevant documentation within in deadline after validation is finished.                 验证完成之后，在规定的时间内完成相关文件更新和存档。

 

  1. Execute machine improvement when machine have down time, high scrap rate occur, and quality issue in the long time run.　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　      当发生设备停机、废品率升高、长期存在质量问题时，进行设备改进工作。

 

  1. As process owner is responsible for handling compliance issue and all kinds of audits as well as relevant findings action.                                                                                             处理合规问题和应对审计，对所有发现点采取行动。

 

  1. Use SPS problem solving method for troubleshooting.                                                       运用系统解决问题的方法解决问题。

 

  1. Handle all reported quality incidents and close them on time.                                               按时处理并解决质量事件。                                          

 

  1. Daily monitor product scrap rate and making relevant action plan. 　                                       监控产品废品率并采取相关行动。

 

Qualifications

  1. Bachelor Degree and above 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。
  2. 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。
  3. Fluent in written and reading English.                流利的英语听说技能。
  4. Minim 4-6 years of relevant working experience.           至少4-6年相关工作经验。
  5. Experience in automation and mechanical areas.           机械、自动化领工作经验。
  6. 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。
  7. Experience of GMP/ISO 9001/ISO 13485 regulated production, validation and change procedures.         GMP、ISO9001、ISO13485标准化要求的生产、验证、变更管理流程的工作经验。

 

Working at Novo Nordisk

At Novo Nordisk we recognise 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 the communities we operate in.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

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.

 

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