锦鲤求职岗位描述
1.严格遵守公司职业操守与合规相关管理条例
Strictly adhere to company’s regulations and compliance rules.
2.负责进行上游细胞培养的所有生产活动（如细胞复苏和摇瓶传代，一次性生物反应器细胞培养，细胞发酵液收获等）并确保批生产活动符合当前 GMP 要求
Perform all upstream cell culture manufacturing activities, including but not limited to vial thawing, shake flask expansion, single-use bioreactor operations, and harvest of cell culture materials, while ensuring full compliance with current GMP (cGMP) requirements.
3.在有限的指导下能够独立执行生产项目并领导员工按计划完成生产任务
Independently execute production projects with limited supervision, coordinate manufacturing activities, and lead operators to complete production on schedule.
4.在上级领导下执行生产项目，按生产计划完成生产任务，并按照GMP要求填写批生产记录
Execute production projects with guidance of supervisor, complete production tasks according to the production plan, and complete batch production records in compliance with GMP requirements.
5.负责按GMP要求进行洁净区内的清洁消毒工作，如周期清洁、清场清洁和设备表面清洁等。
Perform cleaning and sanitization activities in cleaning areas in accordance with GMP requirements, including periodic cleaning, changeover cleaning, and equipment surface disinfection.
6.负责SOP/MBR/URS/FAT/SAT等文件的起草/升版。
Be responsible for drafting/revising SOP/MBR/URS/FAT/SAT or other documents.
7.协助生产过程中流程优化及持续改善
Contribute to process optimization and sustain improvement.
8.负责配合部门对其他有需求的员工进行相关培训，并按时完成个人的培训任务。
Provide or coordinate job-related training for employees as required and ensure timely completion and maintenance of individual training records.
9.参与相关变更，偏差的调查执行，以及审计整改活动计划的执行。
Participate in the investigation and implementation of relevant change control and deviations as well as audit and improvement activities.
10.具备基本英语听说读写能力，本科需要通过 CET-4，硕士通过 CET-6. 能接受每月不超过 2-3 个夜班值班。
Possess basic English listening, speaking, reading and writing skills. Candidates with a bachelor’s degree shall pass CET‑4, while those with a master’s degree shall pass CET‑6. Able to accept no more than 2‑3 night shifts per month.
11.具备较好的学习能力、沟通能力以及团队协作能力。
Demonstrate good learning agility, communication skills, and the ability to work effectively in a team environment.
12.大学本科以上学历，生物、化学、医药工程等相关专业，或具有同等工作经验的人员
Bachelor's degree or above, major in biology, chemistry or engineering, or equivalent industry experience.