1. Independent creation of qualification/validation protocols and test sheets (DQ, IQ, OQ, RA etc.);
独立起草确认/验证方案和测试表单（设计确认，安装确认，运行确认，风险分析等）；
2. Precise qualification/validation execution in customer site (IQ, Calibration, OQ, software validation , isolator cycle development and cycle validation etc.);
客户现场精确执行确认/验证工作（安装确认，校验，运行确认，软件验证,隔离器的循环开发和循环验证等）；
3. Qualification/validation support for Syntegon other CoC’s projects.
支持星德科其他公司的确认/验证项目；
4. Validation project management and presentation of own projects;
所负责验证项目的管理和报告
5. Other duties as assigned(e.g. Measuring device management; Regular calibration; preventive maintenance and material purchasing).
执行其他交付的任务（例如：测试仪器的管理；常规年度校验；仪器的维护和物料采购）。
岗位要求/Job Requirements:
1. Bachelor degree or above in pharmaceutical, Microbiology. Biological engineering or related major. Validation experience in pharmaceutical company is preferred;
药学，微生物学，生物工程或相关专业，本科或以上学历。具有药厂工作经验者优先。
2. Excellent English in both spoken and written, CET6 or above.
英文6级及以上，良好的口语和书写能力；
3. Knowledge of current national and international GMP guidelines and GAMP
具有当前国内和国际的GMP和GAMP知识；
4. Advanced document writing skills using MS Office suite
熟练运用office办公软件
5. Communication ability with all levels of people and Flexible, good problem solving skills.
良好的沟通表达能力，具有灵活性，善于解决问题
6. Team player with good organization and coordination skills, attention to details.
较强的组织协调能力，关注细节，具有团队合作精神
7. Pro-active, high sense of responsibility, excellent time management skills
高度的责任心，工作积极主动，善于合理分配时间.
8. Flexible and willing to travel
能够经常出差.