生产工艺工程师 牡丹江

月薪： 0.6-1万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 01-02 发布
  • 五险一金
  • 免费班车
  • 绩效奖金
  • 年终奖金
  • 专业培训
  • 定期体检
  • 免费公寓

职位描述

Working for the manufacturing department, Manufacturing Process engineer will be responsible for the following but not limited to： 在生产部工作，生产工艺工程师将负责以下但不限于1.Responsible for leading the operation and training of the Lyophilizers；负责带领操作和培训使用冻干机；2.Preparation, review and implementation of SOPs and protocols；编制，审查和执行SOP及方案计划；3.Participate in all the operation of the Lyophilizers including CIP, SIP, setup and parts change over；参加所有冻干机的操作，包括CIP,SIP，设置和部件更换；4.Assist with the set up, and operation activities of the Cleanroom Isolators；协助洁净间隔离器的设置和操作活动；5.Support engineering department with relevant data for improving equipment efficiency and productivity；为工程部提供相关数据以提高设备的效率和生产率；6.Assist management during investigation reports.协助管理层进行调查报告；7.When required participate in the Weekly Operations Organization Meeting；如有需要，参加每周的运营组织会议；8.As required, participate in the Clean / sanitize filling areas / room spaces；根据要求，参与清洁/消毒灌装区域/空间工作；9.Set up the filling equipment / format parts in accordance with the batch records；根据批记录设置灌装设备/格式零件；10.Undertake aseptic simulations of the filling process according to procedures.按规程进行灌装过程的无菌模拟；11.Undertake line clearance of the filling areas / room spaces；承接灌装区域/房间空间的生产线清洁；12.Complete batch records for the filling process as each step is completed；完成每一步的灌装过程的完整的批记录；13.Support the routine preventative maintenance of the filling equipment；支持灌装设备的日常预防性维护；14.Support the non-routine maintenance of the filling equipment；支持灌装设备的非日常维护；15.Support filling equipment qualification, validation and revalidation.支持灌装设备确认、验证和再验证。16.Complete any other tasks assigned by supervisor or manager.完成主管或经理安排的其他工作任务。 职能类别： 药品生产/质量管理

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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