Filling engineer-工艺工程师-验证
Tianjin, Tianjin, CN
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，天津扩建项目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 Tianjin project 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 written and reading English. 流利的英语听说技能。
Professional Experience专业经验:
• Minim 7 years of relevant working experience. Thereinto minim 5 years of production experience in aseptic process of cGMP regulated pharmaceutical industry or in life science industry. 至少4-6相关工作经验，其中至少2-5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 equipment management/maintenance. cGMP或者GMP生产相关工艺设备管理/维护的知识和工作经验。
• Experience of working in cross function team environment. 在跨职能团队环境中的工作经验。
• Strong documentation experience. 文件处理经验。
• Filling Isolator experiences is a plus. 隔离器灌装机经验优先
Job content工作内容描述
Key areas of responsibility 主要工作职责:
Process engineer is operational responsible during project execution, ensuring SRV/ Science- and Risk-based validation 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:
• Responsible for Design Review, FAT/factory acceptance testing, SAT/Site Acceptance Testing, Commissioning, IV/Installation Verification, OV/Operational Verification and improving OEE in ramp-up
设备负责人，负责灌装机的设计、建造、安装、调试、验收、验证，以及量产阶段的OEE提升
• SRV/Science- and Risk-based validation
验证相关工作
• 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 internal or external audit finding.
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。
• Handle critical NCs/ICs/CCs fast with high quality by finding root cause and no comments during audit. 找到根本原因，快速、高质量地处理关键NC/IC/CC，确保审计中没有问题。
• Write critical CR and complete change on time. 撰写CR并按时完成。
• Plan validation and 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验证和再验证，撰写验证文件。
• Write process and validation related documents with high quality, including PSE, VSS, VSR, APR, QMR, etc. 撰写工艺和验证相关文件，包括：PSE, VSS, VSR, APR, QMR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：
o 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。
o 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。
o Drive 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。
o Ensure anchoring of process improvement projects. 实施工艺改进项目。
o Be responsible for ensuring that local standards are translated in accordance with DFP standard. 负责确保DFP标准转化到本地标准。
• Train the trainer in production support team. 培训生产支持团队的内部讲师。
• Ensure daily support and sparring to production units and support units within the process area including: 确保对日常生产的工艺支持：
o Ensure that efficient process KPIs are defined and followed up upon. 制定高效的工艺关键绩效指标并跟踪执行。
o Drive problem solving/event response to local problems and comprehensive NCs. 推动问题解决和复杂NC的处理。
o Identify improvement opportunities and implement locally with documented benefit and drive local improvement projects. 寻找改进点并实施改进，推进改进项目执行。
o Own local standards. Be responsible for developing and maintaining local procedures and standards within the process, including local JTP’s and training material. 负责开发和维护本地工艺流程标准，包括准备培训材料和培训计划。
o When standards are changed ensure that relevant training documents are updated and initiate training of relevant employees by informing LoB about new standard. 当有标准变化时，及时通知相关业务部门，更新培训文件并对相关员工实施培训。
o Coach or ensure SOPs and standards within the process are effective by evaluating how they are used and work in praxis through PC. 通过进行过程确认确保工艺相关SOP和标被准有效地执行。
o Ensure compliance to external and internal regulations. 确保合规
o Responsible for presenting process during inspection and audit. 在审计和检查时介绍工艺流程。
o Be ‘on point of entry’ to the process regarding solution. 作为工艺解决方案的唯一接口人。
• Participate in validation, technology transfer and process improvement: 参与验证、技术转移和工艺改进：
o Ensure the validation and verification of process, machine and equipment. 确保实施对工艺流程、机器、设备的核查和验证。
o Be responsible for critical event response and NC handling during validation. 验证过程中处理关键问题和关键NC。
o Review and approve validation document and share best practices with relevant stakeholders. 检查并批准验证文件，分享最佳实践方法。
o Escalate problems according to escalate procedure. 按照程序上报问题。
o Be aseptic behaviour owner in process department by leading smoke study. 无菌区域行为规范负责人。
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.