WS Area Specialist I

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 reading, written and spoken English.        流利的英语听说读写技能。Professional Experience专业经验:

•      Minim 10 years of relevant working experience. Minim 5 years of production experience in aseptic process of cGMP regulated pharmaceutical industry or in life science industry. 至少10相关工作经验，其中至少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 validation/qualification.            cGMP或者GMP生产制造工艺流程验证的知识和工作经验。

•      Strong knowledge and experience in cleaning and sterilization process and related equipment.

在清洗和灭菌工艺以及相关设备上拥有丰富的知识和经验

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

•      Strong documentation and Audit experience.            丰富的文件和审计经验。

Job content工作内容描述

Key areas of responsibility 主要工作职责:

WS Area Specialist is Technical Lead of WS process during project execution, ensuring good design of process and equipment fit for the future production demand. Ensuring SRV 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：

•      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。

•      Design and carry out experiment or justification (CDS, PJ etc.) to find process operational parameter range to ensure stable production

设计和开展实验（如CDS，PJ等）来寻找工艺参数运行范围以确保生产稳定。

•      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

Compliance and Quality System related task 合规与质量体系相关工作:

•      Maintenance the compliance between authority and NN requirement, also between the global standard and local SOPs.                                                                                                 基于内/外部规则和总部/本地标准的要求，维护生产的合规性。

•      Well prepare for audit in order to obtain high rating in NN internal audit and pass all inspection from authorities. Be the owner of audit/inspection finding action.                                                 充分准备审计以通过NN内部审计和外部检查并取得优异结果。担任审计发现的改善行动负责人。

•      Drive investigation of DVs/ICs/CCs based on SPS, minimize impact on production and product release and make corrective/preventive actions

基于SPS推动偏差/内部投诉/外部投诉的调查，减少对生产和产品放行的影响并制定纠正/预防措施

•      Be responsible and write CR, ensure sufficient stakeholder involvement and evaluation, complete change on time.                                                                   

负责和撰写变更，确保利益相关方的参与和充分评估，及时完成变更。

•      Be responsible and write process and compliance related reports including SOP, APR, QMR, QRM, Trend reports etc.

负责和撰写工艺与合规相关报告，包括SOP, APR, QMR, QRM, 趋势报告等

•      Monitor the process trending.                                                                               监控工艺流程趋势。

Lead and drive process optimization and improvement. 推动工艺优化和改进：

•      Lead and coach improvement activities, improvement of standards within assigned process.

指导和训练改进活动和工艺流程标准的改进。

•      Participate in event response activities using SPS method, establishing cause and effect relationships that determine root causes. Leverage solution, best practices and benefits to process group through business case.

运用系统解决问题的方法处理事件，确定根本原因，通过事件处理案例平衡解决方案、最佳实践方法以及对工艺部门的益处。

•      Ensure anchoring of process improvement projects. 实施工艺改进项目。

•      Develop training and Train the trainer in production support team.                                            开发培训并培训生产支持团队的内部讲师。 

Technical Lead and competence development for the team技术带头人和团队能力建设：

•      Be acuminous to the front technology and regulation, drive concept design and set technical direction to ensure STJ has sufficient technical solution to full fill business needs. Have high influence in IFP global technical group.

对前沿技术和法规保持高度敏锐，引领概念设计和技术方向来确保STJ有足够技术来达成业务目标，在IFP全球组织中有较高影响力。

•      Direct handling complicated problem (drive team when necessary) with systematic approach and clear report.

用体系化的工具和方法直接处理复杂问题（需要时组建并带领问题解决团队），并做清楚的汇报

•      Develop and coach other engineers.

发展和培养其他工程师    

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

•      The position needs oversea travel under business need

根据工作安排，此职位需要海外差旅

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.