CU area specialist II

Category:  Engineering
Location: 

Tianjin, Tianjin, CN

   

Qualifications (minimum requirements) 任职资格

Education Background: 教育背景

 

  • Bachelor or Master Degree, major in water treatment, pharmaceutical engineering, chemical engineering or other relevant fields.               水处理、制药工程、化学工程等相关专业大学本科以上学历
  • Fluent in written and reading English.             流利的英语听说技能。

 

 

Professional Experience专业经验:

 

  • Minim 8 years of manufacturing working experience in pharmaceutical industry or in life science industry. Familiar with cGMP regulation related to pharmaceutical water treatment.                       至少8年制药相关行业生产制造工作经验。精通制药水处理相关cGMP规范。
  • Minim 5 years engineering experience in water system maintenance, operation, process improvement, root cause analysis (RCA).                                 至少5年水处理系统运行、维护、工艺改进以及故障根本原因分析等技术的工程类经验。
  • Have clean utility process knowledge and validation skills in the following systems: Chinese purified water, water for injection, clean steam and process air system.                                               具备纯水、注射用水、洁净蒸汽、洁净压缩空气等无菌公用工程相关的工艺知识和验证技能。
  • Proven expertise in execution of inspection/audit and compliance improvements activities, following up on results, and revising the work plan for complex problems being resolved by cross functional teams on time.                                                  具备专业的实际应审能力和合规改进能力,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。

 

 

 

Job content工作内容描述

Key areas of responsibility 主要工作职责:

The CU Area Specialist is responsible for pharmaceutical water systems process and compliance of whole production support area and there through lines running smoothly which includes audit/inspection activities, GMP interpretation, process and compliance improvements and relevant coaching and training.

 

洁净设施领域专家总负责生产支持业务区域制药水系统的工艺,系统稳定运行以及合规性,包括:应对审计和检查、GMP要求解读

工艺和合规改进、以及对员工提供相关培训和指导。

Main Job Tasks 主要工作任务:      

  • Development and execution clean utility system process optimization and standardization following cLEAN thinking according to the requirements of site business needs and site strategy.                             根据公司业务需求和战略目标,遵循精益生产理念,正确发展和执行洁净共用工程系统的过程优化和标准化。

 

  • Manage and drive compliance and quality improvements of clean utility system to meet the cGMP requirements and global compliance project management, high qualified competence in the handling process of audit and inspection.                                                                            管理和推动洁净公用工程系统的合规和质量改进,满足cGMP和诺和诺德内部合规项目管理的需求,完全胜任内审和外审等审计过程。

 

  • Actively initiate continued improved CU system to meet the requirement of system stable, safe and high-efficiency running; cause analysis and PM/CM action setting up by Lean thinking and tools.                 主动实施洁净公用设施系统的持续改进以保证系统稳定、安全、高效地运行。将精益生产的理念和工具应用到预防性维护、日常维修以及故障根本原因分析中。

 

  • Development and implementation of system reliability/energy saving improvement projects and have the competence in CR/NC handling during daily operation and maintenance.                                    发展和实施有关系统稳定运行和节能运行的项目,并且具备处理项目改进以及日常运行维护中的CR/NC的能力。

 

  • Technical support of different engineering disciplines in project upgrade. Have right competence in external vendor management, minor projects management, validation process and GMP compliance.                 在系统项目改进过程中给予技术支持;对外部供应商及内部改进项目实施管理;具备系统验证能力和GMP合规性管理能力。

 

  • Actively involve all learning and sharing activities of Global Process group to ensure compliant to NN process requirement and take ownership to initiate the activities of area coaching and sharing.                      积极参与诺和诺德工艺负责组的所有活动,并进行积极分享和主动学习,确保天津工厂的洁净设施系统与全球的要求高度合规,并且积极实施部门内部的培训和分享活动。

 

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.