Key responsibilities
• 根据项目转移计划，负责工艺资料的接收、管理
Receiving and management of process documentation according to TTP
• 结合车间设备的实际情况，根据工艺设计生产流程(完成设备流程图)，作差异化分析并提供解决方案
On the basis of real situation of equipment, design process workflow according process (make equipment flowchart). Analysis and provide solution for equipment gap
• 负责编写工艺的相关文件，如MBR、RA、WI等，并对操作人员做相关培训
Compile relevant process file, such as MBRRAWI and so on, and training relevant operators.
• 负责工艺验证和生产过程中的技术指导工作
Responsible for process validation and guidance of process technology of production
• 发现并解决生产中的工艺技术和安全问题，对偏差和安全问题进行调查和根本原因分析
• Finding and resolving process and safety issues in production. Investigate and root cause analysis of deviation and safety issue 配合生产计划做好SAP系统的工艺数据统计工作
Cooperate with production planner and provide the process data statistic for SAP system
• 负责整理、分析生产中的工艺技术参数并结合研发人员提供的数据优化生产工艺
Statistic and analyzing the process parameters of production and coordinate with data from R&D to optimize process
• 根据需要完成各类文件的修订和升级
Revise and update kinds of file
• 参与GMP或FDA认证的相关工作
Participate in the authentication for GMP and FDA
• 上级主管安排的其他工作。
Other tasks assigned by manager as required.

主要经验和技能
Critical Experience and Skills
• 要求在化药行业有3年以上的经验。
3+years’ Experience on pharmaceutical requirements.
• 具备解决问题和持续改进生产的能力。
Demonstrated ability to problem solving and production continues improvement.
• 具备外资企业工作经验者（企业语言为英语）优先考虑。
Work experience with foreign company (corporate language English) is preferable.
• 本科及以上学历，化学工程、制药工程等相关专业优先。
Bachelor or above degree in Chemistry Engineering, pharmaceutical engineering or equivalent is preferred.