制药设备工程师(清洗/灭菌)
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 Expansions 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 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。
Job content工作内容描述
1、根据公司产品工艺需求，与设备供应商和总部对接，完成设备选型、方案设计、操作规程的审核与制定，追踪设备采购进度
2、获取项目设计资料，根据项目要求，负责和审核完设计类、评估类、验证类、手册类、清单类等各种类型文件；
3、根据项目计划及、项目验证策略URS要求，负责在项目中制定验证计划与策略，如引用、遗留、偏差、变更、附件、报告的签批时间；
4、负责现场项目验证管理与实施，统筹管理现场项目验证工作，包括文件更新、与供应商及总部对接、验证实施及管理、验证工作安排、验证数据和报告整理、报告提交客户审批、验证变更/偏差处理等协调处理所有项目验证过程产生的偏差和问题；
5、负责现场项目验证进度推进，制定项目验证总进度计划，跟踪影响验证进度的问题进展；
6、根据公司体系结合系统项目的要求，做好与跨部门的验证文件对接，优化完善标准产品的文件模版，确保有效、一致性、符合法规要求；
7、负责项目验证总结报告的起草及签批，交付后验证项目相关文件的归档，以及项目总结与分享，并提出改进项和控制策略建议；
8、负责设备验证结束后的设备、工艺改进，提升产能减少浪费
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.