ETO灭菌验证专员

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 1.responsible for the ETO sterilization equipment installation, operation, product identification;
负责ETO灭菌设备的安装、运行、产品鉴定；
2.responsible for the routine process validation, including authentication scheme, data, report preparation and finishing;
负责常规下的工艺验证，包括相关验证方案、数据、报告的编制和整理；
3.responsible for the routine sterilization process parameter settings and confirmation;
负责日常灭菌工艺参数的设定和确认；
4.responsible for day-to-day sterilization parameters and report confirmation;
负责日常灭菌参数及报表的确认；
5.responsible for sterilization and equipment repair, maintenance and other related files are established;
负责灭菌和设备维修、保养等相关文件的建立；
6.responsible for the safety of operating personnel training;
负责车间操作人员安全操作培训；
7.responsible for the production of field personnel standardized operation, material import, handling, storage and protection, environmental protection, production safety management work.
负责生产现场人员规范操作、物料进出、搬运、储存和防护、环境维护、生产安全等规范管理的工作。




1.mechanical, electrical， biological & chemical and other related professional, college or above;
机械、电气、生化等相关专业，具有大专及以上学历；
2.at least 3 years working experience and above ETO sterilization validation;Familiar with ISO11135,
至少3年及以上ETO灭菌验证工作经验；
3.ISO11737 standard and can skillfully use, basic knowledge of ISO13485 quality management system standards;
熟知ISO11135、ISO11737等标准并能熟练应用、基本了解ISO13485质量管理体系标准；
4.has good writing and language skills;
具有良好的文字书写及语言能力；
5.has a good team spirit and ability to get along with people;
具有良好的团队精神及与人相处的能力；
6.good English reading and writing ability, CET4 or above,proficient in reading literature.
良好的英语读、写能力，英语四级及以上，能熟练阅读文献。