Clean Utility Engineer ?

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，在年和年和年荣获Kincentric“最佳雇主”称号。 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，天津扩建项目位于天津市滨海新区睦宁路，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 Tianjin project is located at 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! Education Background:
Bachelor Degree or above major in water treatment, chemical engineering, pharmaceutical or other relevant fields.
Excellent communication skill in written and spoken English.
Professional training of cLEAN 2 star or an equivalence.cLEAN2星或者同等培训经历。 Professional Experience 专业经验 :
Minim 5-8 years of experience in pharmaceutical manufacturing with cGMP regulation.
少5-8年制药加工行业相关工作经验，熟悉cGMP规范。 Engineering experience in water treatment systems (covered purified water, water for injection and clean steam etc.
design, maintenance, operation, process improvement and root cause analysis.
Proven expertise in execution of validation and GMP relevant documentation (NC/CR/QAP) etc.
Following up on the process and relevant stakeholder and revising the work plan for complex problems being resolved by cross functional teams on time.
和GMP相关文件等的处理能力，并且具有应急复杂问题分析处理能力以及跨部门协作沟通解决问题能力。 Have knowledge in the following systems:
mechanical, pharmaceutical utility, process design and project management etc.
Experience of project management is preferable.
Experience of instrument is preferable.
Key areas of responsibility 主要工作职责 :
Senior CU engineer is responsible for compliance of daily system running and maintenance activities that to ensure stable and high quality deliveries of water, steam and process air for AP production.
Work according to cGMP, GMP, GDP and SOP.
Ensure NC, CR, QAP, validation, etc.
are accomplished within schedule.
Drive process improvement and standardization.
级CU工程师的职责是保证日常设备系统运行和维护活动合规，确保为无菌生产供应稳定并且高质量的水、蒸汽、空气。遵循cGMP 、GMP、GDP和SOP执行工作，确保NC、CR、QAP、验证等工作按计划完成。推动工艺改进和标准化。 Main Job Tasks 主要工作任务 :
New Clean Utility System Design 洁净设施设备系统设计： Participate in supplier evaluations to ensure that selected suppliers meet NN requirements.
足NN的要求。 Participant in project management to ensure assignments in compliance with agreed time schedule, budget and quality requirements.
Review the documents provided by the design institute, give opinions according to the requirements of URS, ES, and complete the signing of design drawings/document with the design institute.
据URS, ES的要求给出意见，并和设计院一起完成设计图纸/文件的签署。 Participate in CU design review meetings for risk assessment, joint design institute, QA, and OR/ER approvals.
与CU部份的design review meeting进行风险评估，联合设计院，QA，以及OR/ER批准。 Responsible for the URS, ES of the CU system, involve HQ and QA to review, approve the URS, ES, and work with the design institute to make sure the design complies with URS, ES.
责URS，ES，与总部及QA复核， 批准URS和ES，并和设计院一起将URS，ES落实到设计当中。 On-site construction and installation 现场施工和安装 Participate in supplier/vendor/TPR supervision or management to ensure that they perform their work by strictly following the procedures and standards of NN and the deliverables from them meet NN requirements.
足NN的要求。 Participate in equipment selection, FAT and SAT of CU to ensure the smooth installation and commissioning of CU systems.
，FAT以及SAT，确保CU系统的顺利安装及调试。 On-site adjustment and installation 现场调试和验证 Support and coordinate within work package and external stake folders to ensure delivering effective solutions, interface management and validation dependencies.
Prepare, review, and involve QA to approve the clean utility systems validation plan and validation report to ensure that the validation of the clean utility meets SRV requirements, cGMP and local standards.
并involve QA 批准clean utility系统的验证计划和验证报告，确保clean utility的验证满足SRV要求，cGMP法规及中国法规的要求。 Participate in the verification of the clean utility system, ensure that the clean utility system can meet the needs of URS, handle engineering changes and verification deviations in the verification process according to NN requirements, establish a baseline after the completion of the verification, and ensure that the CU system is released to the user on time.
与CU系统验证，确保CU系统能满足URS的需求，按NN要求处理验证过程中出现的工程变更以及验证偏差，在验证结束后建立基准，并确保CU系统按时放行给用户。 Daily maintenance and operation Participated and support to establish of new plant high level project management documentation establishment, such as PQMP, VPL, IAR, etc.
如PQMP，VPL，IAR等。 Participant in setup the system periodic evaluation of the CU system, handle CR and DV during operation according to NN procedure.
据NN要求实施运行过程中的变更及偏差处理 Handle temporary system failures, and use SPS methods to analyse the root causes, and take corrective and preventive measures accordingly.
用SPS的办法进行原因分析，并采取相应的纠偏以及预防措施。 Develop quality mindset in the area to ensure compliance with legal or regulatory requirements and NN quality system including policies and safety rules.
Drive or participate in event response activities on own site using systematic problem solving, establishing cause and effect relationships that determine root cause.
Leverage solutions, best practices and benefits to PG group through business cases according to MSP.
照MSP的要求通过实际业务案例向工艺负责组说明解决方案、最佳实践方法和益处。 Ensure anchoring of process improvement projects in local site project portfolio.
Share and prioritise solutions and improvement projects.
Evaluate and implement process solutions and better practices locally and across DFP according to MSP.
照MSP的要求分享改进项目，确定解决方案的优先次序，在天津工厂以至于DFP范围内评估并执行解决方案和最佳实践。 Participate in validation, technology transfer and process improvements including参与验证活动、技术转移和工艺改进 Escalate problem according to escalation procedure.
Ensure compliance to external and internal regulations.
Other individual assignments 其他工作任务 :
Be the process responsible for clean utility.
Drive process improvement in Site Tianjin and across DFP.
于DFP范围内推动工艺改进。 Monitor process performance and report performance to Process Group responsible.
Lead and coach improvement activities and improvement of standards within the assigned process.
Develop process competence on site, across DFP and support other DFP sites when relevant.
为DFP其他工厂提供支持。 Drive the MSP process on site, including developing and reviewing CR cases for relevant changes which including update of global DFP standards, coordinating of CR cases, giving feedback on the status of ideas/input to the originator of idea.
含DFP全球标准变更的变动事件，协调变动事件的执行，向建议提出人反馈意见和改进执行情况。 Be responsible for ensuring that local standards are translated in accordance with DFP standard.
保DFP标准转化为本地标准。 Responsible for presenting process under inspection and audit.
Be ‘one point of entry’ to the process regarding solutions.
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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