下游蛋白纯化助理工程师-MFG2 FDSP

Job Responsibility

1. 01

   负责按GMP要求进行蛋白质纯化等生产工艺操作。 Responsible for purification and other process operation per GMP requirement.

2. 02

   负责按GMP要求进行洁净区内的生产准备工作，如在线清洗，泄露测试，在线灭菌及设备表面清洁等。 Responsible for production preparation work per GMP requirement, such as CIP, LT, SIP and equipment cleaning, etc..

3. 03

   负责物料的协助采购，跟踪，管理等。 Responsible for assistance in procurement, tracking, managing the raw materials.

4. 04

   负责设备的协助定制/采购，协助验证/校验/维护，以及设备管理等。 Responsible for assistance in customization/procurement, assist qualification validation/ calibration/ maintenance, and management of the process equipment/instruments.

5. 05

   负责SOP/CC/DV/MBR/URS/FAT/SAT等文件的起草/升版。 Responsible for the draft/revision of SOP/CC/DV/MBR/URS/FAT/SAT and other documents.

6. 06

   负责生产过程中的取样/送样/样品管理。 Responsible for sampling, sampling delivery and sample management during production.

7. 07

   负责生产过程中的生产计划和人员工作安排，以及任务完成情况追踪。 Responsible for the production plan and staff work arrangement, and task completion tracking during production.

. 其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills)

1. 01

   具有蛋白质纯化等生产操作的相关知识/经验。 Knowledge in GMP production about cell expasion, cell culture, depth filtration, etc.

2. 02

   具有较好的沟通能力和理解能力。 Ability to communicate and understand well.

3. 03

   工作积极向上并具有良好的学习能力。 With an optimistic work attitude and good learning ability.

4. 04

   具有吃苦耐劳的品质及良好的身体素质（至少提起15Kg的重物）。 Must be hard working and physically fit the job (must have the ability to lift a minimum of 15kg).