WS engineer-维修工程师

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年和2022年荣获Kincentric“最佳雇主”称号。

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.

诺和诺德成立灌装&成品扩建项目部，主要负责产品供应&质量&信息技术部（PSQIT）在全球范围内灌装&成品扩建项目的筹划、建设。我们的目标是通过应用新技术，提升产能，持续满足患者需求的同时，打造未来新标杆。

作为该项目部成员之一，天津无菌制剂生产厂项目（三厂）位于天津市滨海新区睦宁路60号，毗邻现有天津生产厂。在这里你将有机会与来自全球各地，拥有不同文化背景的伙伴一起工作，一起致力于驱动改变，改善数百万糖尿病和其他慢性疾病患者的生活！

心动不如行动，快来申请相关岗位吧！

Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and build all major fill & finish expansion projects across Product Supply, Quality & IT to serve the needs of millions of patients. We do it by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the facilities of the future, designing facilities we will still be proud of 20 years from now.

As a part of that, Fill & Finish Expansion Site Tianjin is located at No. 60, Muning Road in TEDA, adjacent to the current manufacturing site. Here, you will be working with multiple sites and cultures across the world to join efforts to drive changes and improve the lives of patients with diabetes and other chronic diseases.

Apply now if you wish to be a part of this exciting global program in Novo Nordisk!

Qualifications (minimum requirements) 任职资格

Education Background: 教育背景

•      Bachelor Degree and above in mechanical engineering, industrial engineering, electrical engineering, chemistry, pharmacy, bioscience, computer science or similar education background. 机械工程、工业工程、电子工程、化学、制药、生物以及计算机科学或相关学科领域大学本科及以上学历。

•      Education/training of cGMP is preferable. 最好接受过cGMP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 7 years of relevant working experience. Thereinto minim 5 years of production experience in aseptic process of cGMP regulated pharmaceutical industry or in life science industry. 至少4-6相关工作经验，其中至少2-5年cGMP规范药厂或者生命科学行业无菌生产的工作经验。

•      Knowledge and experience on cGMP or GMP manufacturing process equipment management/maintenance. cGMP或者GMP生产相关工艺设备管理/维护的知识和工作经验。

•      Experience of working in cross function team environment. 在跨职能团队环境中的工作经验。

•      Strong documentation experience. 文件处理经验。

Job content工作内容描述

Key areas of responsibility 主要工作职责:

WS Maintenance engineer is engineering responsible during project execution, ensuring SRV/ Science- and Risk-based validation implementation, product quality and compliance, prepare for audit readiness and execution, validation and revalidation. The position plays an important role in cGEP and cGMP, and continuously improving standards in operation process.

Main Job Tasks 主要工作任务:     

SRV/Science- and Risk-based validation验证相关工作：

•      Responsible for Design Review, FAT/factory acceptance testing, SAT/Site Acceptance Testing, Commissioning, IV/Installation Verification, OV/Operational Verification and improving OEE in ramp-up

设备负责人，负责设备的设计、建造、安装、调试、验收、验证，以及量产阶段的OEE提升

•      Review and approve design and engineering documents (including PID, FS, ES, Wiring Diagram, CCA etc.) to ensure correct equipment construction and in compliance with URS.

审核和批准设计与工程文件（包括PID, FS, ES, 电路图, CCA等）来确保设备符合URS的正确制造。

•      Design, plan, lead and carry out initial validation, establish validation state in compliance with regulatory and NN requirements on time.

设计、计划、驱动和实施初始验证，及时建立验证状态并确保符合法规与NN的要求。

•      Write validation related documents with high quality, including VPL, FAT/SAT, IV/OV/PfV plan/report, SE, VSS, TMX, etc. 

撰写验证相关文件，包括：VPL, FAT/SAT, IV/OV/PfV plan/report, SE, VSS, TMX, etc.  等 。

•      Plan and carry out re-validation with shortest stop for production and write high quality validation documentation.

在保证最短停产时间的前提下计划和实施再验证，撰写验证文件

•      Drive Investigation of Validation Deviation, minimize impact on validation activity and make corrective/preventive actions

推动验证偏差的调查，减少对验证活动的影响并制定纠正/预防措施

Maintenance and Continue Improvement Related task设备维护与改进相关工作:

•      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 DV, 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。

•      Cooperate with production, process and supplier to continuous improve OEE, reduce down time, reduce scrap rate, minimize production impact caused by machine. Handle CR (change) for machine improvement and optimization.

与生产、工艺和供应商合作持续改进OEE、减少停机时间和不良率，减少因设备带来的生产影响。为设备改进撰写变更。

•      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。

•      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.