生产技术工程师-制剂

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;