1、Participate in equipment design confirmation, installation, commissioning and validation during plant interior construction, assist lyophilization supervisor, complete DQ, FAT, SAT, IQ, OQ and PQ of production equipment, mainly including bottle washers, tunnel ovens, lyophilizers, automatic feeding and unloading and their CIP stations, etc.

2、Assist the lyophilization supervisor to complete the development of production-related documentation system within the GMP system, lyophilization process-related protocols, risk assessment, job operation SOPs and production equipment operation SOPs. 

3、Assisting the lyophilization supervisor to complete pilot batches, engineering batches, PPQ, media simulation tests, product process validation, cleaning validation and trial production. 

4、Completing the transfer of the product production process from R&D to production and organizing the post for trial production to ensure that the post achieves continuous and stable production operation.

5、Assisting the lyophilization supervisor in solving technical problems and deviation investigations that occur during the decontamination and lyophilization process.

6、Responsible for the daily production operation of lyophilization of sterile preparation products, filling of post production related records, daily cleaning and maintenance of lyophilization equipment. 

1、College degree or above, more than 1 year of experience in lyophilization production of sterile injectables. 

2、Familiar with the relevant production, process and operation procedures of lyophilized formulations, and proficient in lyophilization production operations. 

3、familiar with the use and maintenance of lyophilization process equipment and facilities.

4、Familiar with drug production quality management norms and GMP site management and document preparation. 

5、Familiar with workshop validation, can assist the lyophilization supervisor to complete the process validation, cleaning validation, equipment validation and other work in the lyophilization workshop.