技术工程师/高级工程师

1.参与技术转移及解决技术转移过程中的问题，并协助进行技术方面的偏差调查；

Participate in products technology transfer and provide the solution during TT and assist to do the deviation investigation.

2. 根据转出方提供的工艺文件，起草可行性评估报告，技术转移方案，与各部门进行技术沟通交流等；

According to the process document from sending unit, draft feasibility assessment report, TT protocol, and communicate with other departments.

3.组织/参与工艺验证的相关活动；例如起草工艺规程，工艺验证方案及报告，协调/参与工艺验证生产活动等；

Organize/Participate in the related activities of process validation, such as draft product process procedure, process validation protocol and report, coordinate/participate in the process validation activity.

4.负责建立ERP产品配方和工艺，组织/参与工艺、技术相关变；

Responsible for building formula in the ERP system and organize/participate in the change of product process change and other technology related.

5. 负责/参与上海工厂产品技术改进和工艺变更；

Responsible for technology improvement and process change control

6. 持续优化/改进技术转移的标准和规程，起草/维护技术部相关规程；

Continuously optimize/improve the standards and procedures of technology transfer process, draft/maintain the related procedures of technology department;

7.负责/参与部门日常工作，例如培训、安全等；

Responsible for/participate in the daily work of the department, such as training, EHS.,etc.

任职要求：

1.大学本科或以上学历，药学/化工/工程等相关专业；

Bachelor degree or above, major in Pharmacy/Chemical/Engineering or related subjects

2. 至少5年及以上药品生产企业等相关工作经验；

Minimum 5 years of working experience in pharmaceutical manufacturing or related experience.

3. 熟悉口服固体制剂相关设备和工艺；

Familiar with the oral solid preparation related equipment and process

4. 熟悉中国GMP, 欧盟GMP ，美国GMP，FDA，ICH等药品相关法规和技术指导要求

Familiar with the requirements of GMP，cGMP, EU GMP，FDA，ICH related regulation and guideline.

5.善于沟通，有专业的责任心，具有良好的团队组织经验和分析、解决问题能力；具有良好的项目管理经验。

Good communication skills, professional responsibility, good team organizational experience and analysis problem-solving skills, good project management experience.