MSAT技术转移和工艺验证（高级）工程师 - 杭州

1 负责技术转移, Facility/Process fit, 新产品引入评估，撰写PFD/BOM

Responsible for tech transfer, Facility/Process fit and new production introduce assessment and draft PFD/BOM.

2 负责场地变更/工艺设备变更/物料变更/工艺变更的技术评估和影响分析

Take charge of technical assessment and impact analysis of manufacturing site change/process related equipment change/material change and process change.

3 负责工厂内新型技术/设备引入的技术评估与影响分析，并参与验证

Responsible for technical assessment and impact analysis on new technology/equipment introduction, and take part in validation.

4 负责工艺验证方案设计与执行，验证报告的签批

Responsible for designing and implementing process validation, tracking validation report to take effect.

5 参与厂房内商业化生产项目的持续验证确认，周期性回顾和再验证

Take part in continuous productions verification, periodic review and re-validation of commercial projects.

6 临床后期的项目管理（生产），协调PD/MFG/ENG完成Gap analysis和Trouble shooting所需的实验或者测试

Managing late-stage production projects, cooperate with PD/MFG/ENG to complete experiments or tests due to Gap analysis and trouble shooting.

7 按需参与审计支持工作

Engaged in supporting audit as needed.

8.按需支持各site（包括海外 site）的技术转移及生产技术支持等相关工作

Global technical support for technology transfer and manufacturing as needed to various sites, including overseas sites.

•      本科及以上学历，生物、化学、医药工程等相关专业，或具备同等工作经验者

•      Bachelor’s degree or above in biology, chemistry, pharmaceutical engineering, or related disciplines. Equivalent relevant experience may also be considered.

•      具备上游或下游工艺经验，熟悉细胞反应器控制或纯化单元操作及其基本控制参数；具有细胞培养或纯化工艺研发或生产经验者优先

•      Experience in either upstream or downstream processes, with familiarity in bioreactor control or purification unit operations and their basic control parameters. Experience in cell culture or purification R&D or manufacturing is a plus.

•      具备GMP基础知识，能够在受监管的质量体系下开展工作，确保活动符合数据完整性和可追溯性要求

•      Basic understanding of GMP principles, with the ability to perform work within a regulated quality system, ensuring compliance with data integrity and traceability

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•      具备良好的沟通能力与结构化思维能力

•      Strong communication skills and structured thinking.

•      具备良好的英文沟通、会议组织及技术文档撰写能力

•      Proficient in English communication, meeting coordination, and technical writing.