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Maintenance Engineer III

5 months ago

Tianjin, China Novo Nordisk Full time

   

诺和诺德（中国）制药有限公司天津生产厂是诺和诺德全球唯一的胰岛素耐用注射器械供应商，以及重要的胰岛素制剂与灌装生产基地，在2019年，2020年及2022年荣获Kincentric“最佳雇主”称号。

 

Education Background: 教育背景

  • Bachelor degree major in mechanical and automation engineering, electrical or similar field. 机械工程、自动化工程、电气工程或相关学科大学本科毕业或以上学历
  • Education or training in GMP and LEAN. 接受过GMP规则和LEAN相关培训
  • Excellent English skill in written and spoken. 熟练的英语听说读写技能。

 

Professional Experience专业经验:

  • Minimum 3-5 years of working experience in manufacturing factory. Prefer clean room or aseptic area experience. 两年以上生产制造企业工作经验，最好有无菌环境的经验。
  • Experience of equipment maintenance in aseptic process of cGMP regulated pharmaceutical industry. cGMP规范的制药厂无菌生产流程的设备维护经验。
  • Knowledge in the following systems: pneumatic system, utilities, instrument and electrical, especially PLC and motion control system. In addition ability and experience with automated records systems such as SAP system. 具备如下系统的专业知识：气动系统，公用工程，仪表，动力控制，SAP系统。

 

Key areas of responsibility 主要工作职责:

Maintenance engineer is responsible for implementing corrective maintenance and preventive maintenance work according to SOP. To ensure AP equipment are running with high performance and low variation. Perform equipment incident handling, machine improvement and optimization that to ensure process in compliance with safety, production or quality requirements as well as standards. 维修工程师负责按照标准操作流程执行生产设备维修工作，确保无菌生产设备稳定高效地运行。处理设备问题，执行设备改进和优化，以确保工作流程符合安全、生产、质量以及标准的要求。

 

Main Job Tasks 主要工作任务:      

  • Take the responsibility of machine owner. Implement corrective maintenance and preventive maintenance according to SOP. Ensure all machines troubleshooting timely. Ensure machines running well with high performance and low variation. Ensure safety when working with machine.  担任设备负责人，遵循SOP的要求执行生产设备日常维修保养和定期检修，及时解决问题确保设备运行状况良好。保证工作安全。
  • Ensure stability batches, media fill, PV batches and production batches are executed according to milestones. Clear communicate with production team to make sure production will not be impacted.  保证生产按计划执行，与生产团队良好沟通以确保设备维修活动不影响生产。
  • Establish and improve equipment maintenance standards, processes/procedures and system to meet GMP requirement.  按照GMP的要求建立和改进设备维护标准、工作流程和程序等。
  • Handle NC, investigate the root cause and cooperate with production team and process team together try to close it by cLEAN tools systematically.  处理偏差，调查问题的根本原因，与生产团队和工艺支持团队一起合作运用精益生产的工具系统的解决问题。
  • Handle CR (change) for machine improvement and optimization. When there’re machine issues occur such as production risk, high scrap rate, machine down time caused by design, unreasonable method，the responsible engineer will seek for machine improvement and optimization method through contacting supplier of OEM supplier. When doing this required CR, support to finalize CR case to handle the whole process from the beginning to the end of machine update.  处理变动以改进和优化设备。当设备发生问题时，如：生产风险、废品率升高、停机、不合理的方法， 维修工程师要与设备供应商一起寻找改进和优化的方法。
  • Participate in new project and new machine introduction at the early beginning of project of new machine. Participate in design review and test review so that some error can be found earlier. Execute test and validation. 参与新项目和新设备引进；审核设计和测试方案尽早发现问题；执行设备测试和验证。
  • Operate SAP PM& MM system to support maintenance work and spare parts management, open and close work order. 操作SAP系统，支持日常维修工作以及备件管理，处理系统工作订单。
  • Ensure all maintenance activities are done according to SOP, passing all internal and external audits without any findings about SOP compliance. 确保所有维修活动按照SOP执行，符合质量要求，通过内、外部审计。
  • Make sure all maintenance activities are in compliance with safety, production or quality requirements or standard. 确保所有的维修活动合规，符合生产、安全、质量的要求。

  • Participate in validation, technology transfer and process improvements 参与验证活动、技术转移和工艺改进

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.