职责概要：



上游生产相关工作。



岗位职责：



1、 参与上游生产设备的FAT/SAT/IQ/OQ/PQ；



2、 准备上游生产相关的文件；



3、 按照工艺规程和批记录进行工艺操作；



4、 负责生产现场管理，确保生产现场整洁有序；



5、 负责上游设备的维护与保养；



6、 及时上报生产过程中发现的任何异常情况，并协助上级进行处理。



任职资格：



1. 本科或以上学历，生物学，药学或相关专业；



2. 生物制药行业2年及以上工作经验；



3. 熟悉细胞培养技术和工艺放大，至少具有200L规模一次性或不锈钢反应器的经验；



4. 了解设备验证、清洁验证以及工艺验证的流程，有参与或实施过设备验证；



5. 了解生物药相关GMP法规要求；



6. 良好的沟通和执行能力；有责任心，能够承受挑战性工作的压力。



7. 英语流利优先；






Position: Upstream Production Engineer



Location: Suzhou



Job Summary:



The candidate will be responsible for upstream operation.



Responsibility：



1. Participation in FAT, SAT,IQ,OQ,PQ of relevant equipment in USP Production；



2. To be responsible for preparation the relevant files;



3. Participation in upstream production operation according to procedure and records；



4. To be responsible for the management of the production site to ensure the cleanliness and orderliness of the production site;



5. Maintenance of upstream equipment；



6. Timely report any event found in the production process and assist the superiors to deal with it.



Qualification:



1. Bachelor degree or above, biochemical or related major;



2. 2 years or above working experience in biopharmaceutical industry;



3. Familiar with cell culture technology and scale-up, at least 200 L disposable or stainless bioreactor experience;



4. Familiar with the process of equipment validation, cleaning validation and process validation, participate in or implement equipment validation;



5. Familiar with GMP regulations for biological drugs;



6. Good communication and execution ability; Responsible and able to work under pressure.



7. Fluent English is a plus;