Process Engineer III

3 weeks ago

Tianjin, China Novo Nordisk Full time

   

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年及2022年荣获Kincentric“最佳雇主”称号。

 

Education Background: 教育背景

  • Bachelor’s 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 4-6 years of relevant working experience. Thereinto minim 2-5 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 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。

 

Key areas of responsibility 主要工作职责:

  • Process engineer is operational responsible during project execution, responsible for validation; cycle development;
  • PfV including the validation protocol and report preparation. Process engineer is also responsible for the audit readiness and execution.
  • During the production phase, process engineer is responsible for ensuring production quality and compliance, prepare for revalidation. The position plays an important role in continuously improving standards in operation process.

 

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. 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。
  • Handle DVs/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DV/IC/CC，确保审计中没有问题。
  • Write 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 OPV, VSS, VSR, APR, QMR, etc. 撰写工艺和验证相关文件，包括：OPV, 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
  • 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  确保对日常生产的工艺支持
  • Participate in validation, technology transfer and process improvement 参与验证、技术转移和工艺改进

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.

 

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