下游生产纯化工程师(MFG3）

1.1    负责按GMP要求进行器具准备、缓冲液配制、下游蛋白纯化等生产活动的执行，确保批生产活动符合当前GMP的要求

Be responsible for instrument preparation, buffer preparation, downstream protein purification and other process operation per GMP

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1.2     协助完成项目的生产前准备工作包括文件、仪器及物料等进行及时的跟踪、总结和更新。

Coordinate the timely follow up, summary and update of the manufacturing preparation including documents, equipment and raw materials for projects assigned

1.3     负责按GMP要求进行洁净区的清洁消毒工作，如清场清洁和设备表面清洁等。

Be responsible for cleaning in the clean area per GMP requirement, such as changeover cleaning and equipment cleaning, etc.

1.4     负责提交物料需求、设备预约等工作。

Be responsible for requiring the raw materials, booking equipments.

1.5     协助设备的采购、验证、校验、维护和管理等工作。

Coordinate the ordering, validation, calibration, maintenance and management of the process equipment/instruments.

1.6     负责起草和升版GMP相关文件，包括但不限于SOP/MBR/URS/FAT/SAT。

Be responsible for drafting/upgrading SOP/MBR/URS/FAT/SAT or other GMP related documents.

1.7     参与偏差的启动和调查、变更的启动和实行、纠正和预防措施的执行。

Involving in the initiation and investigation of deviation, initiation and execution of change control, implementation of CAPAs.

1.8     负责部门文档的管理，如文件分发、回收、归档等。

Be responsible for document management including receiving, distribution, recalling and archiving GMP documents.

1.9     按时完成个人的培训任务，配合其他部门对其他有需求的员工进行相关培训。

Be responsible for training or coordinating training, and maintaining individual training record on time.

1.10  负责部门日常行政事务，完成上级交待的其他相关任务。

Be responsible for group or department administrative affairs. Perform the task assigned by leader. 

人员资质 PERSONAL QUALIFICATION

专科以上学历，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。

Junior college degree (or above) with major in Biology, Chemistry, Pharmaceutical Engineering, related Science major or person with equivalent experiences.

具有缓冲液配制，下游蛋白纯化等GMP知识和相关工作经验者优先。

Persons with knowledge and experience in GMP production about buffer preparation, downstream protein purification etc. are preferred.

具有下游蛋白纯化等工艺研发经验者优先

Persons with experience in process development of downstream protein purification are preferred.

具有较好的沟通能力和理解能力。

Have good communication and understanding ability.

具有吃苦耐劳的品质及良好的身体素质。

Have the spirit to bear hardships and hard work and good physical quality.

有团队协作精神，工作积极向上并具有良好的学习能力。

Have team work spirit with an optimistic work attitude and good learning ability.