Maintenance Area Specialist

Education Background: 教育背景

•      Bachelor Degree or Master Degree in technical field or industry equivalent experience or similar education background. 技术应用、工业技术或相关学科领域大学本科及以上学历。

•      Education/training of cGMP regulation. 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:

•      Demonstration of 8 years or above subject matter expertise in aseptic production technical area, in pharmaceutical industry or in life science industry. 具有8年以上在无菌生产，或是生命科学技术领域的工作经验

•      In-depth knowledge & experience in overall DFP aseptic production equipment & process flow aspects, including following high-speed & automated systems: Filling, Formulation, W&S, Inspection, remote control system design/research/development & application, material automatic transformation system design/ research/development & application, Equipment AI, Big Data system research/development & application, equipment & system validation, etc. 在无菌生产设备/流程领域/远程控制/人工智能/大数据领域具有深厚的技术背景及经验。

•      Proven in-depth expertise & primary leadership in mentoring/coaching/development, design & change management, planning/organizing, managing execution, and revising the work plan for complex problems solved by task force from cross functional/cross areas/cross sites. 在指导和开发、变动管理、计划与组织、管理执行以及适应跨职能团队解决复杂问题需要修改工作计划方面有丰富的经验。

•      Rich experience driving process design/improvements using systematic methodologies; lean and six sigma skills are strongly preferred. 具有运用精益生产管理方法持续改进工艺的经验。

•      Working independently in cross functional team environment, while handing specialist tasks of high complexity which critical contribute to Area/Site/DFP business target & strategy. 适应跨职能团队合作，可独立运行高复杂度的工作并为了区域/工厂/总部的相应目标做出贡献。

Purpose of the Job职位目标:

AP Technical Support specialist is overall responsible for relevant automatic & intelligent system design/research/development/implementation & improvement of AP all equipment & process, also responsible for managing projects to ensure delivering according to project plan. And also need to cooperate & coordinate with global supplier for technical innovation development, collaboration & exhibition, etc.

全面负责相关的自动化与智能化系统的设计/研发/实施及改进，同时负责相关的项目的支持，以保证项目的顺利实施。

AP Technical Support Specialist need to involve AP & STJ strategy setup & execution, to meet STJ & DFP, PS business target & long-term strategy development.                                                                        

需要在无菌生产部门及工厂战略目标制定及运行过程中起到关键作用。

AP Technical Support Specialist will on behalf of STJ AP to involve or lead cross site/DFP/PS high-level collaboration of specialist group, for cross site net work & sharing platform setup & driving, which play most key role in technical innovation & strategy development of whole DFP, even PS.                                                           

此岗位将会作为天津工厂无菌生产部门技术代表的身份参与到跨工厂合作的活动中，在经验分享，技术革新等方面起到关键性作用。

The AP Technical Support Specialist is critically impact & contribute for the following indicators of all AP core equipment & process flow - W&S, Formulation, Filling, inspection:                                                    

此岗位需为以下重要的业务指标的达成起到关键性的贡献的作用：

•      Line Capacity & Stability生产线能力及稳定性的提升

•      Scrap Rate & First Pass Yield提出率的降低以及首件通过率

•      Spare Parts Control 备件控制

•      Green Reality Development & Roadmap Green Reality项目路线图的制定及实施

•      Hoshin_Kanri 战略部署                                                                                           

•      Product Transfer产品转移

•      MTBR/MTTR

•      OEE3 & L/H Level

•      Work order completion工单完成率

•      Validation验证

•      Compliance合规性

Main Job Tasks 主要工作任务:     

•      Responsible for providing aseptic technical expertise on equipment & process flow.                

负责提供无菌生产设备及流程的专业技术

•      Responsible for resolving technical needs and driving improvement opportunities.                           

负责解决技术需求，推动改进。

•      Responsible for assisting technical by providing non-conformity support.                                     

通过支持NC处理促进技术改进。

•      Responsible for coaching and leading investigations for technical-related issues.                             

负责带领及指导相关的技术难题的调查研究。

•      Acts as a maintenance advocate, coordinating daily schedule, removing barriers and enabling maintenance to run optimally.                                                                                             

作为维修负责人，协调日常工作，排除障碍，确保维修工作最优化执行。

•      Serves as coach and technical mentor for Equipment & Process Owner, maintenance teams and relevant process teams.                                                                                              

担任工艺团队、工艺协调人、维修技术人员的教练和技术指导。

•      Real time Coaching/mentoring of engineers/professionals in maintenance & technical aspects:               

在日常维修工作中实时指导技术员和工程师:

o     FIT/MWD                                                                                           

故障调查和维修工作说明.

o     Preventative and Predictive maintenance standards                                                 

预防性和预见性维系标准

o     Maintenance role cards                                                                             

维修职责卡.

o     Technical systematic problem solving                                                               

解决技术问题

o     Execute process confirmation of maintenance standards used on shift and work with maintenance & process team to find ideas to proactively improve quality and compliance                           

做维修标准在工作中执行情况的过程确认，前瞻性地改进质量和合规性

o     Coordinate relevant technical & process training                                                    

协调相关的技术&工艺培训.

•      Ensure continuous development of aseptic production area quality and principles by systematic collection of knowledge and standardization of technique and validation and supported by cLEAN® tools:                

系统收集知识，标准化技术和验证，并辅之以 cLEAN ®工具，确保无菌产区质量和原则的不断发展

•      Ensure “Knowledge exchange” across departments, projects and sites                                       

确保跨部门、跨项目、跨工厂的"知识交流"。

•      Develop and update relevant tools, methodologies and training materials                                    

开发和更新相关工具、方法和培训材料。

•      Stay updated on latest developments within technique, validation and Lean principles from internal and external sources.                                                                                            

随时了解并导入来自内部和外部来源的技术、验证和精益原则的最新发展趋势。

•      Automatic system & equipment design/research & development                                             

自动化系统&设备设计/研发

•      Lead or participation in STJ project group or DFP project groups of projects which will be transferred to STJ.

领导或参与将要实施到天津工厂的项目的项目组或DFP项目组.

•      Lead or Participation in mechanical & automation system design robustness challenge meeting, in STJ or DFP.                                                                                                         

在 STJ 或 DFP 中领导或参与机械和自动化系统设计稳健性挑战会议

•      Recommendation & management of specifications optimization.                                             

相应的操作规程及规范优化的建议与管理

•      Design of test setups.                                                                                       

测试装置的设计

•      Lead or participation in production maturing, optimization & development activities.                         

领导或参与生产成熟度改善、优化和发展活动

•      Planning and follow-up of activities with subcontractors, consultants and designers.                         

规划和跟进与分包商、顾问和设计师相应的项目活动

•      Take the role of Subject Matter Expert.                                                                      

在以下方面承担技术专家的角色：

o     Present process during audit & inspection. Guide audit tour on shop floor. Coordinate with department fulfil audit request. Support to answer questions during audit and inspection.

在审计和检查过程中介绍当前的流程。与部门协调满足审计要求。支持在审计和检查期间回答问题

o     Ensure global SOP & GMP requirements implementation. Review documentation and do gap analysis for SOP and reports to ensure compliance.                                                 

确保总部SOP及GMP要求的落实。审查文档并为SOP和报告进行间隙分析，以确保合规性。

o     Coaching on compliance and train engineers on process knowledge. Identify compliance gaps in responsible process, share finding s and new regulation requirements.                             

辅导并培训工程师的合规性方面及流程知识。确定责任流程中的合规差距、共享发现和新的监管要求

o     Review NC/CR and give inputs. Provide professional idea to continuous improvement. Share best practice across sites.                                                                               

审查NC/CR并提供建议。提供不断改进的专业理念。跨工厂共享最佳实践

•      Coach/mentor process coordinators, engineers, and technicians in resolution of MTTR, MTBF, ramp-up following PM1, function BCO time, Ramp-up, and maintenance/technical.                                    

扮演教练/导师，流程协调员的角色与工程师和技术人员共同寻求解决方案在 MTTR、MTBF、PM 方面的提升。

•      Coach/mentor/teach process coordinators, engineers, and technicians in reliability management system activities.                                                                                                  

在可靠性管理系统活动中指导和训练工艺协调人、工程师和技术员。

•      Execute on shift maintenance plan, review and close work orders.                                          

执行倒班维修计划，检查和完成工作订单。

•      Quickly flexes to changes in the work environment and is able to prioritize business needs with grace and ease.                                                                                                      

在工作中根据业务需要按照任务紧急程度和难易程度安排优先顺序迅速应对变化。

•      Looks for common goals. Demonstrates behavior consistent with “for me to win the team must win” beliefs.                                                                                                    

工作中始终体现团队合作的信念和行为

•      Demonstrates a disciplined, systematic approach to problem solving that is based on data and facts.       

基于数据和事实，用系统的方法解决问题。

•      Builds strong working relationships within the team and with other departments

•      Observes and enforces all safety and environmental requirements

•      Models the NNWay

•      Performs other duties as required

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.