工作职责:
1 生产部门制剂相关偏差、变更的协助处理；
Deviations and change control handling related to DP process;
2 技术转移（制剂相关的资料撰写、工艺差距分析和风险评估、放大工艺研究）；
Technical Transfer (Manufacture Fill & Finish documents drafting, process gap analysis and risk assessment, process scale-up analysis ;
3 根据风险评估，制定培养基模拟灌装策略以及清洁验证和PPQ的验证策略
Define the strategy of Media fill, cleaning validation and PPQ based on risk assessment
4 生产部门制剂相关工艺文件的撰写（PS、BPR等）；
Draft and review manufacturing process specification, batch production record, etc. ;
5 制剂相关的新技术/物料的测试与评估；
Perform tests and assessments for new Manufacture Fill & Finish technology/material;
6 审计或检查时，制剂相关的相关生产技术问题的解答；
Answer questions related to Manufacture Fill & Finish production process during audit;
7 制剂相关的生产人员的技术及法规培训；
Responsible for personnel training such as Manufacture Fill & Finish technologies and regulation related training;
8 制剂相关的生产数据的总结和分析回顾；
Analysis and retrospective review of Manufacture Fill & Finish production data;
9 制剂生产工艺的持续改进；
Consistent optimization of Manufacture Fill & Finish process;
10 完成上级交办的其他工作。
Complete other tasks assigned by leader;

任职资格:
1 本科或以上学历，生物工程、生物化工、制药工程、生物化学等相关专业毕业；
BS degree or above in Biological Engineering, Biochemical Engineering，Pharmaceutical Engineering， Biochemistry or equivalency;
2 有无菌生产相关经验、设备确认经验者优先；
Aseptic production related experience or equipment qualification experience are preferred
3 具有良好的品德操守和职业道德；
Good moral backgrounds and professional ethics;
4 具有良好的责任意识，工作积极主动，具有团队合作精神；
Be willing to take responsibilities, optimistic and a good team work;
5 具有良好的沟通能力，较强的抗压能力；
Good communication skills and able to handle pressure;
6 具有较强的逻辑思维能力，沟通协调能力，较强的思考解决问题的能力，良好的英语读写听说能力，熟练的使用电脑办公软件;
Strong logics, communication skills and problem-solving skills, good with spoken and written English, and Microsoft Office tools;