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Sr. Process Engineer

Category:  Engineering
Location: 

Tianjin, Tianjin, CN

   

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.                                     工业工程、化学、制药、生物以及材料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7相关工作经验,其中至少5cGMP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
  • 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。

 

Job content工作内容描述

Key areas of responsibility 主要工作职责:

Senior process engineer is responsible for ensuring production quality and compliance, prepare for audit readiness and execution, validation and revalidation. The position plays an important role in continuously improving standards in operation process.  高级工艺工程师的职责是保证日常生产的质量和合规性;保证审计准备就绪和应对审计;验证与再验证。高级工艺工程师是持续改进生产工艺标准的关键角色。

 

Main Job Tasks 主要工作任务:      

  • 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. Represent Site Tianjin to answer the process related questions of during internal or external audit/inspection. 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。在审计或检查中代表天津工厂回答工艺相关的问题。担任审计发现的改善行动负责人。
  • Be the CAPA owner for investigation. Handle critical NCs/ICs/CCs fast with high quality by finding root cause and no comments during audit.                                                                             担任纠正和预防活动的负责人。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.                                                              撰写关键CR并按时完成。
  • Be the owner of process risk assessment. Plan validation and re-validation with shortest stop for production and write high quality validation documentation.                                                            担任工艺风险评估负责人。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。
  • Instruct or write process and validation related documents with high quality including QRM, VMP, VMP, PPP, PPR, PSE, VSS, VSR, APR, QMR, etc.                                                                        指导或撰写工艺和验证相关文件,包括:QRM, VMP, VMP, PPP, PPR,OPV, VSS, VSR, APR, QMR
  • Monitor the process trending and lead or coach investigation for abnormal trending.                         监控工艺流程趋势,推动或者培训对非正常趋势的调查。
  • Lead global process optimization/improvement project locally and ensure the local implementation of DFP standard.                                                                                                   带领全球工艺改进项目的本地化实施,确保按照DFP统一标准执行。
  • Be process responsible of Site Tianjin or back up.                                                           担任天津工厂工艺流程负责人的角色。
  • Lead and drive process optimization and improvement.                                                      推动工艺优化和改进:
    • Be process responsible or back up to represent STJ for discussing and aligning improvement among DFP sites. Ensure the local implementation of DFP standardization.                                作为流程负责人代表天津工厂与其他DFP工厂探讨工艺改进, 确保按照DFP统一标准执行。
    • 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。       
    • 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。
    • Ensure anchoring of process improvement projects.                                                实施工艺改进项目。
    • 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:
  • 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。
    • Drive CAPA investigation. Be the CAPA monitoring responsible to continuously monitor and analysis input sources to identify quality problems.                                                         推动纠正和预防活动研究,持续监控和分析并发现质量问题。
    • Drive problem solving/event response to local problems and comprehensive DVs.                   推动问题解决和复杂偏差的处理。
    • 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。
    • Be responsible for the local implementation of global standard or procedure.                        负责全球标准和程序的本地化执行。
    • Be or instruct the owner of local standards. Be responsible for developing and maintaining local procedures and standards within the process, including local JTP’s and training material.            指导本地标准的负责人,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。 
    • 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。
    • 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。
    • Ensure compliance to external and internal regulations.                                             确保合规      
    • Responsible for presenting process during inspection and audit.                                    在审计和检查时介绍工艺流程。
    • 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:
    • Lead product transfer or local implementation of global project.                                    领导产品转移项目
    • Own the process risk assessment and ensure the validation status of process or equipment is maintained based on risk assessment.                                                              负责工艺风险评估,确保流程或者设备验证基于风险评估进行。
    • Instruct on or participate in local validation and verification of process, machine and equipment.  指导实施对工艺流程、机器、设备的核查和验证。
    • Be responsible for critical event response and VDV handling during validation.            验证过程中处理关键问题和关键验证偏差。
    • 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。
    • Escalate problems according to escalate procedure.                                                按照程序上报问题。
    • 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

 

 

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年和2020年连续两年荣获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.

 

诺和诺德志在成为世界上最卓越的公司之一。我们坚信,怀抱不同观点、来自不同文化背景的人才相聚于此,是成就卓越企业的关键。因此,我们致力于倡导包容性,让我们的员工、我们服务的患者以及我们置身的社区能够充分拥抱多样性。我们承诺在招聘流程中确保包容性,并为所有求职者提供平等的职业机会。同时,我们热衷于根据不同工作职责和业务需求来探索灵活工作的模式。

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.