Formulation Engineer III

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。

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，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！

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 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:

Formulation engineer is operational responsible/Engineering responsible during project execution, 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

• 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 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NC/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 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：

• 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

• 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.