GMP设备工程师 牡丹江

月薪： 0.6-1万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招2人
  • 01-02 发布
  • 五险一金
  • 免费班车
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 定期体检
  • 免费公寓

职位描述

1.At the direction of area supervisor.在该领域主管的领导下工作。2.Prepare, review, implement and maintain the process equipment SOPs.起草、审核、实施和维护工艺设备的SOP。3.Prepare, review and implement and manage the process equipment preventative maintenance program.起草、审核、实施和管理工艺设备的预防性维护程序。4.As required participate in the Weekly Operations Organization Meeting.根据需要参加每周的运营部会议。5.Maintain the component preparation equipment (USBs, autoclave, stopper processor and discharge isolator) including monitoring, preventative maintenance and repair.管理组分准备设备（USB、高压灭菌柜、胶塞处理机和卸载隔离器），包括监控、预防性维护和维修。6.Maintain the formulation equipment (formulation isolator and disposable formulation system) including monitoring, preventative maintenance and repair. 管理配制设备（配制隔离器和一次性配制系统），包括监控、预防性维护和维修。7.Maintain the filling equipment (vial washer, depyrogenation tunnel, vial filling and stoppering, vial lyophilizers, lyophilizer loading & unloading, vial capping, vial exterior decontamination and vial tray loader) including monitoring, preventative maintenance and repair.管理灌装设备（西林瓶清洗机、隧道烘箱、西林瓶灌装和加塞、冻干机、冻干机装载和卸载、西林瓶压盖、西林瓶外表面净化和西林瓶装盘机），包括监控、预防性维护和维修。8.Maintain the filling isolator system (vial filling, lyophilizer loading & unloading, vial capping and exterior vial decontamination) including monitoring, preventative maintenance and repair. 管理灌装隔离系统（西林瓶灌装、冻干机装载和卸载、西林瓶压盖、西林瓶外表面净化），包括监控、预防性维护和维修。9.Maintain the decontamination equipment (USBs and parts washer) including monitoring, preventative maintenance and repair.管理净化设备（USB和部件清洗机），包括监控、预防性维护和维修。10. Maintain the ILP equipment (vial inspection, labeling and cartoning) including monitoring, preventative maintenance and repair.管理ILP设备（西林瓶灯检、贴签和装箱），包括监控、预防性维护和维修。11. Maintain the laboratory equipment (procedure isolators, biological safety cabinets, fume hoods, parts washers, environmental chambers and laboratory instruments) including monitoring, preventative maintenance and repair.管理实验室设备（隔离器、生物安全柜、通风橱、部件清洗机、环境室和实验室仪器），包括监控、预防性维护和维修。12. Maintain the facility cold rooms (retained storage and finished goods) including monitoring, preventative maintenance and repair.管理冷库（留样储存和成品），包括监控、预防性维护和维修。13. Maintain the inventory for the spare parts and consumables for the process equipment.管理工艺设备的备品备件库存。14.Through the Business Department order the required spare parts and consumables for the process equipment.通过业务部门采购工艺设备的备品备件。15.Support the process equipment qualification, validation and revalidation.为工艺设备的确认、验证和再验证提供支持。 职能类别： 生物工程/生物制药

联系方式

海林市海林经济开发区东旭路7号

公司信息

公司总部位于美国加利福尼亚州圣地亚哥，生产工厂位于中国东北部风景优美的黑龙江省。基纳瑞克斯提供包括技术转移、工艺开发、放大实验、设备/工艺验证，配液、灌装、冻干、检验、完整性检测、贴标签及装盒等的整套服务，符合美国食药监局、欧洲药品管理局、中国食药监局及日本法规机构的要求。With our corporate headquarters located in San Diego, California, USA and our manufacturing facility located in the scenic Heilongjiang Province in the north eastern part of China OncoGenerix offers a fully integrated suite of services including technical transfer, process development, scale-up, equipment / process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and cartoning meeting the requirements of the US FDA, EMA, CFDA & Japan Regulatory

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