Senior Metrology Engineer

Category:  Quality
Location: 

Tianjin, Tianjin, CN

   

Key areas of responsibility 主要工作职责:

Ensure metrological and measurement works in compliance with related regulations, standards and internal requirements at STJ. Provide effective measuring data to support DV, CRvalidation or product analysis.确保全厂计量和测量工作符合相关的法规,标准和内部要求,在DVCR,验证以及产品分析方面给与支持并提供有效的测量数据。

As metrology SME to present and answer questions in internal/external audits, inspection etc…Moreover, is also on behalf of metrology for site projects. and help manager drive improvement initiatives                   .   作为计量SME负责应答内外部审计和检查并代表计量团队负责全厂相关项目协调,带领和推动团队创新改善

 

Main Job Tasks 主要工作任务:       

  • Make sure the metrology process is fully compliance with the National Metrology Law and regulations as well as EU, FDA and other international regulations.                                 确保计量过程控制完成符合国家计量法律法规以及EUFDA和其它国际计量法规的要求
  • Secure metrology process in compliance with related the global procedures and internal requirements.                                                                                             保证计量工作符合总部计量规范和内部要求等
  • Develop, qualify, approve new measurement and internal calibration methods, develop and implement metrology procedures, methods and instructions.                                       开发、确认、批准新的测量和内部校准方法,开发并执行计量规程、方法和指南。
  • As the member of the Global Metrology Focus Group for interpreting Chinese Metrology Law, National calibration procedures and GMP requirements of the metrology as well as the international regulation, EU,FDA regulations of the metrology.                                                                       作为总部计量小组成员负责解释中国计量法,国家校准规范和GMP相关的计量要求以及国际规范,EUFDA的计量法规
  • Perform validation for computer system and measuring equipment in the metrology team                  负责计量部门计算机系统和测量设备的验证
  • As an advisor or measurement technical consultant to get involve in any complex decisions and recommend solutions to support site DV, CRvalidation and product analysis, also provide effective measurement / testing data.                                                                                                作为测量技术顾问支持偏差,变更和产品分析及提供解决方案和有效测量测试数据.
  • As SAP super user handle calibration and PM tasks in SAP system.                                          作为SAP高级用户在SAP系统中处理校准和PM任务
  • Site Metrology trainer to train the internal metrology engineers and coordinators on the metrology science principle and advanced metrology knowledge regularly.                                                     负责定期培训公司内部的计量工程师和计量协调员计量科学原理和高级计量知识
  • Develop Internal calibration procedures                                                                     开发内部校验程序
  • Reviewer, approver and consultant for all metrology process and technology procedure, instructions and SOPs as well as internal. external measurement agreement.                                                负责复核、批准和指导全部计量过程控制和技术规程,指导文件和相关SOP以及内部和 外部的测量协议
  • Measuring Laboratory compliance maintenance including measuring request control, utilization rate monitor and report, staff qualification, testing documentation archiving, ambient environment control and EHS aspects.

 

  • 协助负责保持测量实验室符合性,测量管理控制,设备利用率管理,人员资质培训,文档管理,EHS环境控制
  • Back up of the manager for the team management, and help the manager on the metrology budget planning, staff competence improvements and complex measuring equipment introducing.                 作为团队经理的后备,帮助经理制定计量预算计划,人员能力提高和复杂测量设备引进

Can be ready for travel at any time according to business needs.                                   能够根据业务需要随时出差。

 

Other individual assignments 其他 :

  • 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

 

 

Education Background: 教育背景

 

  • Possession of a bachelor's degree in the Physical Sciences, Mechanical, Electrical Technology, Industrial Technology, Engineering, Computer Science or a field related to Metrology or Measurement.

自然科学/机械/电气应用科学/工业应用科学/计量或测量/计算机等相关领域的学士学位

 

Professional Experience专业经验:

 

 

  1. 8-10 years of experience involving the application of knowledge of metrology, measurement and testing techniques

8-10年的计量应用,测量和测试技术经验

 

  1. Advanced knowledge of GMP, Chinese National Metrology Law and regulations and ISO, EU, FDA regulations regarding metrology.

深入理解GMP,中国计量法规,ISOEUFDA相关计量法规知识

 

  1. Familiar with principle and practice of the testing and measurement for the pharmaceutical process

熟悉制药流程相关测量和测试原理和规范

 

  1. Advanced Knowledge of measurement uncertainty and Geometry Product Specification concept and statistical skills.

深入理解测量不确定度和几何产品规范和统计技术相关知识

 

  1. Good communication skills with other stakeholders and good command of English skills on oral and writing.

具备与利益相关方良和的沟通能力,良好的英文听说读写能力

 

  1. Highly quality mindset and engage in continuous improvement.

   具备很高的质量意识和持续改善的敬业度

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.