Maintenance Engineer II

Qualifications (minimum requirements) 任职资格

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专毕业或

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. 至少3-5年生产制造企业工作经验。 · Experience of working in production environment with highly automated machine. 有高度自动化生产设备操作和维护的相关经验。 · Knowledge of GMP, ISO9001&13485 is preferable. 最好有生产相关GMP、ISO 9001&13485的相关知识。

Job content工作内容描述

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 packing line is 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，确保包装生产线稳定高效地运行。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。

· Assure all activities in FP area comply with NN, ISO, EU, FDA and Chinese standards and regulations, and

this is reflected in installations and systems.

保证成品生产区域的所有维修活动、设备、系统符合NN, ISO, EU, FDA以及中国国家标准和规范。

· Establish and improve equipment maintenance standards, processes/procedures and system to meet GMP

requirement. Technical Support Manager 技术支持经理 Technical Support Associate Manager 技术支持副经理 Maintenance Engineer 维修工程师

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 quality support engineers, process engineers, together or try to close it by cLEAN tools systematically. 处理偏差，调查问题的根本原因，与质量支持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 including FAT, SAT, IQ, PQ. 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。

Other individual assignments 其他工作任务:

· Incorporate Novo Nordisk Way (NNW) into daily way of working

将诺和诺德之道（NNW）融入到日常工作中

· Other work assigned by line manager.

直线经理安排的其他工作。

· Keep line manager accurately informed of work status as well as any problems

保证将工作状态和所有问题准确通知到直线经理

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.