锦鲤求职岗位描述
岗位职责：
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.
任职要求：
• 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 requirements.
• 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.