生产改善经理岗位职责

生物制药生产工艺改善高级经理药明生物无锡药明康德生物技术股份有限公司,无锡药明康德生物,药明生物,药明职责描述:

•Provideassistancetotechnicalsupervisorinsupervisingandcoordinatingmanufacturingserviceandmaintenanceactivity

协助技术主管进行生产服务和设备维护活动的管理

•Provideexpertiseonproductionvesselsystem(e.g.bioreactors,medium,buffer,producthold)andprocessofclean-in-place,sterilization-in-placeorintegritytest

支持生物制药工厂大型不锈钢罐体系统的使用和维护,以及为在线清洗灭菌,完整性测试等工艺流程提供专家支持

•Providefluidprocessengineeringsupportforskidsdesign,equipmentselection,andfortroubleshootingarangeofmanufacturingchallenge

支持流体工艺系统设计,设备选型等;为系列生产工艺挑战提供解决方案

•Leadequipmentrelatedqualitydeviationinvestigationandcommunication;supportregulatoryandinternalinspections

负责工艺设备方面的偏差调查,报告撰写,与客户和质量部门沟通;支持外部及内部审计活动

•Provideprocessengineeringsupportforthecommissioning,start-upandoperationofbiologicsplantand/ornewprocessinstalledinthefacilitymeetingGMPrequirement

参与新厂调试,启动和运营;支持新工艺/设备的调试运行,达到GMP要求

•Developandruncomputerprocess/unitmodeling/simulationsinsupportofplantoperations,processfitstudy,

任职要求:

•Master’sdegreeinChemical/biochemicalEngineeringorrelateddisciplinewithaminimumof5yearsofrelevantexperienceinengineeringoroperations.Recentexperienceinabiologicsproductionfacilityisrequired

•化学工程或同等专业硕士,5-8年工作经验;须有近期在生物品制造厂工作经验

•Priorexperienceinoperationordesignaroundheattransfer,fluidprocessing,air/liquidtransferandfluiddynamicsstudy,withgoodfamiliaritywithCIPandSIP

•有操作或者设计热传递,流体工艺,气体/液体传输,流体混合相关的系统或者公艺经验;熟悉在线清洗和在线灭菌

•Understandtheprinciplesoffluidflow,heattransfer,masstransfer;understandbiologicalprocess,andASMEBPEstandardforbioprocessequipment

•理解流体特性,传质,传热等化工原理;了解细胞培养和产品纯化流程及ASMEBPE设备规范

•Proficiencyinusingatleastonemodelingsoftwaresuchashome-builtExcel,Aspen,DesignProorequivalent

•能熟练使用一种模拟软件,自建或者商用模拟

•Exceptionalproblemsolvingandanalyticalskills.

•优秀的分析能力和解决问题的能力