验证工程师

该职位来源于猎聘

• 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）。
• 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）。
• 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。
• Validation project management and presentation of own projects. 所负责验证项目的管理和报告。
• 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
• 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。
• 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。
• 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。
• Advanced document writing skills using MS Office suite. 熟练运用office办公软件。
• 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。
• 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。
• 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。
• Flexible and willing to travel. 能够经常出差。