Job Responsibilities 工作职责：
1.Participate in the daily activities of the purification Manufacturing Group. Apply proper PPE (Personal Protective Equipment) to all work in the facility.
参与纯化组的日常生产活动，应用适当的个人防护用品去完成在厂房内的所有工作；
2.Participate in the evaluation of new technology, new production process and new production technology.
参与评估新工艺、新生产流程和新生产技术；
3.Escalate process issues as necessary to ensure resolution; Anticipate potential problems and take preventative action.
根据需要上报工艺中的问题并保证解决问题；能预见潜在的问题，并采取预防性措施；
4.Author MFG-DSP GMP documents, ensure GMP training requirements are complete and current.
起草蛋白纯化生产部的GMP文件，确保完成和更新GMP培训要求；
5.Ensure operations strictly adhere to all SOPs and cGMP/Quality requirements.
保证严格根据所有的SOPs和cGMP/质量要求来操作；
6.Ensure all work is performed in safe manner, the operation complies with EHS requirements and meets the specifications for each service request.
确保安全的方式去执行所有的工作，操作符合EHS要求，并符合各个服务请求的标准；
7.Clean and maintain the GMP facility and production equipment, maintenance of environmental and personal hygiene.
清洁和维护GMP厂房和生产设备,保持环境和个人卫生；
8.Participate in the internal auditing program for company as required; Serve as department representative on cross-functional teams.
根据需要参与公司的内部审计计划；能够担任跨职能团队的部门代表；
9.Participate in purification production, especially in filtration, including depth-filtration, virus-filtration, DS final filtration, and on-duty.
参与纯化生产，特别是过滤，包括深层过滤、去病毒过滤、原液最终过滤和值班；
10.Organize personnel/resources for filtration manufacturing, including depth-filtration, virus-filtration, DS final filtration, regulated according to cGMP to accomplish department goals and objectives while operating in a safe manner and in compliance with all applicable regulations.
按cGMP的要求，组织人员/资源，执行过滤生产，包括深层过滤、去病毒过滤、原液最终过滤，在满足安全操作和所有适用法规符合性的前提下，完成部门目标和任务；
11.Participate and provide leadership for the daily activities of the filtration manufacturing group.
参与并领导，过滤生产的日常活动；
12.Participate in purification production, especially in ultrafiltration & diafiltration, including on-duty.
参与纯化生产，特别是超滤/透析，包括值班；
13.Organize personnel/resources for ultrafiltration & diafiltration manufacturing, regulated according to cGMP to accomplish department goals and objectives while operating in a safe manner and in compliance with all applicable regulations.
按cGMP的要求，组织人员/资源，执行超滤生产，在满足安全操作和所有适用法规符合性的前提下，完成部门目标和任务；
14.Participate and provide leadership for the daily activities of the UF/DF manufacturing group.
参与并领导，超滤生产的日常活动；
15.Participate in purification production, especially in chromatography, including AC, AEX, CEX, column packing & unpacking, and on-duty.
参与纯化生产，特别是层析，包括亲和层析、阴离子交换层析、阳离子交换层析、层析柱装填与卸载、值班；
16.Organize personnel/resources for chromatography manufacturing, including AC, AEX, CEX, column packing & unpacking, regulated according to cGMP to accomplish department goals and objectives while operating in a safe manner and in compliance with all applicable regulations.
按cGMP的要求，组织人员/资源，执行层析生产，包括亲和层析、阴离子交换层析、阳离子交换层析、层析柱装填与卸载，在满足安全操作和所有适用法规符合性的前提下，完成部门目标和任务；
17.Participate and provide leadership for the daily activities of the chromatography manufacturing group.
参与并领导，层析生产的日常活动；
18.Complete relevant training as required, and operate strictly in accordance with SOPs and BPRs.
按要求完成相关的培训，严格根据标准操作规程和批生产记录来操作；
19.Participate in the monitoring of the production process, review documents, check all calculations (such as BPRs, labels, equipment readings, etc.) .
参与生产过程的监控，审阅文件，检查所有的计算（例如批生产记录，标签，设备的读数等）；
20.Draft and revise the documents of the production department, and fill in production-related applications and records.
起草、修改生产部的文件，填写生产相关的申请和记录；
21.Responsible for cleaning equipment and cleaning areas, maintaining related facilities, and maintaining personal health and hygiene.
负责清洁设备和洁净区域，维护相关设施，保持个人的健康和卫生；
22.Lead troubleshooting efforts to resolve complex process and equipment issues.
牵头故障排除，以解决复杂的工艺或设备问题；
23.Train other technicians in group and individual settings on best practices and compliance to SOPs.
作为团队或个人讲师，培训其他技术人员，使达到最优的操作实践和SOP依从性；
24.Determine GMP training requirements and curricula. Design and conduct, or outsource, training courses to enhance GMP knowledge level among company personnel.
决定GMP培训的要求和课程；为了提高公司员工的GMP知识水准，设计、安排或外购培训课程；
25.Assist MFG Manager in hosting regulatory or due diligence inspections. Act as SME to regulatory agencies. Oversee the timely response and follow-up to any observations.
协助生产经理，接待监管或尽职相关的检查；作为监管机构的SME；督促针对各种观察项的及时反馈和跟进；
26.Review documentation and check all calculations (e.g. batch records, label, equipment reading) .
审核文档，检查所有计算（如：批记录、标签、设备读数）；
27.Communicate effectively and professionally.
高效、专业地沟通；
28.Other work arranged by superior leaders.
上级领导安排的其他工作。
Qualification 任职资格：
1.Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
能够撰写详细的报告和总结，并展示注重细节的文档技能；
2.Communicate effectively and work professionally in a team environment.
善于在团队中进行有效的沟通和专业的工作；
3.Familiar with computer-based systems.
熟悉计算机系统；
4.Must be flexible to work on any shift (day, night, weekend) and capable of standing for a long time to work.
必须灵活的参与任何轮班(白班，晚班，周末)，并能够长时间站立工作；
5.Oral and written communication skills in Chinese and English (Read, Write, Verbal).
良好的中英文读写和沟通能力；
6.Degree of junior college or above in Chemistry, Chemical Engineer, Life sciences or relevant background.
专科及以上学历，化学、化学工程、生命科学或者相关专业。