岗位描述
JOB ACCOUNTIBILITIES: 岗位职责
- Provide automation integration services for process equipment for new plant facilities for WuXi Biologics or customers, and support the design, construction, commissioning and verification of process equipment.
为药明生物或客户新建厂房设施提供工艺设备的自动化集成服务,支持工艺设备的设计、建造、调试及验证。
- Responsible for process equipment automation related affairs of the new factory, including equipment design document confirmation, network architecture confirmation, server/workstation installation and debugging, instrument communication debugging, data backup, clock synchronization, debugging and verification problem solving, etc.
负责新工厂的工艺设备自动化相关事务,包括设备设计文件确认、网络架构确认、服务器/工作站安装调试、仪表通讯调试、数据备份、时钟同步、调试验证问题解决等。
- Acts as internal tech support to upstream cell culture and downstream protein recovery process for general troubleshooting, and as key liaison between manufacturing and PAS team.
为生产细胞培养(上游)或蛋白纯化(下游)提供工艺工程支持和问题解决能力,对接生产团队和自动化团队。
- Provide process engineering support to CIP/SIP/Transfer of stainless steel system.
为不锈钢配液系统的在线清洗,在线灭菌及无菌传输等操作提供工艺工程支持。
- Review process flow chart and process description, Interface with PAS team to translate production process design into executable control procedures and formulations.
审阅工艺流程图和工艺描述,对接自控团队将生产工艺设计转化为可执行的控制程序和配方。
- Support for new facility design and validation, include stainless steel system、centrifugal machine、AKTA system and UF/DF system, such as initiate and review URS、drawing and FS、FAT/SAT、IQ/OQ,etc.
- 支持新厂设计和验证,包括不锈钢系统、反应器、离心机、层析系统、超滤系统等的URS起草审核、图纸及FS起草审核、FAT/SAT、IQ/OQ等。
- Develop solutions and solve technical problems in project execution quickly, in order to ensure project success.
快速制定解决方案,及时解决项目执行中出现的技术问题,确保项目成功。
- Support for Sustaining Improvement Program of existing sites as technical expert.
作为技术专家支持已有工厂的持续改进项目。
JOB REQUIREMENTS: 岗位要求
- Bachelor’s degree in Chemical Engineering, Generic Engineering, Biochemistry, Automation, Electrical& Instrument with a minimum of 5 years of relevant experience in bioprocess industry.
本科及以上,化学工程、基因工程、生物化学、自动化、电气仪表,至少5年以上生物行业相关经验。
- Prior working experience in chemical /biochemical industry; familiar with biologics drug manufacturing process; Good knowledge on key process equipment in a typical DS or DP facility, downstream purification process knowledge(Chrom, UF/DF etc.) preferred.
具备化工/生化行业工作经验;熟悉生物制药生产流程;对典型原液、制剂车间关键工艺设备有良好的理解,熟悉下游纯化工艺者优先。
- Familiar with at least one major brand DCS/SCADA/PLC system and related deployment experience following GAMP5 validation, DeltaV background preferred.
熟悉至少一个主流品牌 DCS/SCADA/PLC系统和相关的GAMP5验证实施经验,DeltaV系统背景优先。
- Strong customer service, coordination, and interpersonal skills; Able to work cross-department and work with multi-discipline to drive project to success.
具备强大的客户服务、协调和人际交往技能; 能够跨部门工作、跨专业合作,推动项目取得成功。
- General knowledge on GMP regulation and requirement.
具备GMP法规要求的一般知识;
- Able to communicate and work across regions and time zones;
能够跨地区和时区进行沟通和工作;
- Good English communication skills.
良好的英语沟通能力。