Job responsibility 工作职责
61 Perform as assistant functions in the qualification of MFG-USPDS area and equipment, as well as the cGMP facility commissioning;
在生产上游原液生产相关区域及设备的验证工作以及cGMP厂房的试运行中充当辅助角色；
61 Manufacture clinical and commercial material according to schedule and is compliant with cGMPs and safety regulations；
根据已排定的计划并在cGMP规范和安全要求下进行临床研究用样品或者商业化产品的生产；
61 Ensure operations are carried out according to documentation (batch records and SOPs) ；
需确保根据文件内容（批记录和标准操作规程）要求进行生产操作；
61 Responsible for the accurate, safe, environmentally responsible, and quality compliant operations of the upstream manufacturing process；
需确保上游生产过程中的操作准确，安全，环境友好且符合质量要求；
61 Perform as assistant functions for creation and on-going maintenance of all MFG-USP related equipment, policies, and procedures;
需在建立和持续维护所有生产上游相关设备、规章和操作步骤过程中充当辅助角色；
61 May author URS, MBR and other technical documents;
可能会起草用户需求说明书，主批记录和其他技术文档；
61 Receive training on the raw liquid production weighing and mixing module and perform related operations according to the document requirements.
接受原液生产称量配液模块的培训并按文件要求执行相关操作。
61 Perform other tasks assigned by the department leader.
执行部门领导安排的其他工作。
Safety and environment 现场安全和环境合规
61 Promote a culture of safe work place through personal actions;
以身作则推动建立安全的工作环境；
61 Adhere to the Company’s safety and environmental protection procedures；
遵守公司的安全和环境保护程序；
61 Comply with the company's EHS policies and regulations, and complete EHS related work.
遵守公司有关EHS的政策和规定，并完成EHS相关工作。
Quality Assurance 质量要求
61 Responsible for maintaining quality standards during the execution of manufacturing process to meet cGMP requirements；
负责在执行生产任务的过程中维护质量标准以遵循cGMP规范的要求；
61 Perform as assistant functions in the investigations related to the manufacturing process. May author deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
在生产过程相关的调查中充当辅助角色，可能需要根据要求起草偏差，不符合项和制定纠正措施及预防措施。需要与质量团队一同协作来高效且合规的处理上述事项。

Qualifications 任职资格
61 Major in Biopharmaceutics, Bioengineering, Bioprocess or other related fields;
生物制药，生物工程，生物过程工艺或者其他相关专业；
61 College degree or above and at least 1-year experience in biopharmaceutical based cGMP manufacturing;
大专以上学历，有一年以上生物制药cGMP生产经验；
61 Hands-on experience in operating disposable bioreactors at scale over 200L in cGMP facility;
具备在cGMP厂房中进行200L以上一次性生物反应器的实际操作经验；
61 Good oral and written communication skills. Technical writing ability required；
良好的表达和书写沟通能力，并且需要一定的技术文档撰写能力；
61 Ability to bear certain stresses. Advanced computer system skills for Microsoft Office suite (Word, Excel, PowerPoint, Outlook);
熟练使用Microsoft Office办公软件 (Word, Excel, PowerPoint, Outlook) 。