Full Time

DS Automation Manager

Posted 2 months ago
Application ends: November 1, 2021
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Job Description

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description

EducEducation/ Professional Qualification

学历/专业资格

 Bachelor or above degree in Pharmaceutical equipment application technology, Automation engineering, Computer engineering, bioengineering or related field.

制药设备应用技术专业,自动化工程,计算机工程,生物工程相关科学学士或以上学位

Technical/Skills Required

技术/技能训练

Ÿ Familiar with the regulatory requirement of CFDA cGMP、EU cGMP、PIC/S cGMP and FDA cGMP.

熟悉CFDA cGMP、EU cGMP、PIC/S cGMP及FDA cGMP的要求。

Ÿ Familiar with automated DS processes, including Production bioreactors, Chromatography, Viral filtration, UF/DF, etc.

熟悉原液自动化工艺,包括生物反应器,层析,纳滤,超滤浓缩/透析等。

Ÿ Familiar with common vendor automation systems (GE – Unicorn, Pall, Millipore, Sartorius, ArteSyn, etc.).熟悉常见的供应商自动化系统(GE-Unicorn,Pall,Millipore,Sartorius,ArteSyn等)

Ÿ Familiar with recipe/method creation and validation.

熟悉配方/方法创建和验证。

Ÿ Familiar with data integrity controls and procedures.

熟悉数据的完整性控制及流程

Ÿ Familiar with Distributed Control Systems (Rockwell, Wonderware, etc.) is desired.

熟悉分布式控制系统(Rockwell,Wonderware等)

Working Experience

工作经验

Ÿ At least 5 years pharmaceutical related manufacturing experiences and at least 10 years manufacturing automation experience.

至少5年以上制药相关生产经验,至少10年生产自动化经验

Language, Computer Literacy, Office Software, etc.

语言能力,电脑知识,办公软件等

Ÿ Good English and computer skill

英语水平良好,会熟练使用电脑

Others

其他

Ÿ Proactive and dedicated with a strong sense of responsibility and integrity;

积极敬业、主动进取、责任心强、正直向上;

Ÿ Competent in organization and coordination, team leadership, analytical skills and problem solving;

有较强的组织协调能力、良好的团队领导力、较强的分析和解决问题的能力

Ÿ Good communication skills

具有良好的沟通表达能力;

Qualification Required

Ÿ Lead and participate in the activities including URS/FAT/SAT/IQ/OQ/PQ of DS department automated equipment

组织并参与原液生产自动化设备的URS、FAT、SAT、IQ、OQ、PQ。

Ÿ Lead and participate in preparing, revising, and management of automation recipes for the DS department.

组织并参与原液生产自动化配方的起草,修订,管理等

Ÿ Lead and participate in computer/software validation jobs of DS department

组织并参与原液生产电脑/软件的验证工作

Ÿ Lead and participate MES project, and response for DS recipe development and maintenance of recipes.

组织并参与工厂MES项目,并负责DS MES处方管理及维护。

Ÿ Provide automation/MES related trouble shooting support when any issue occur during DS routine manufacturing。 To ensure DS production meet production plan.

为原液生产出现的自动化和MES相关的问题提供问题解决支持。保证生产按计划进行。

Ÿ Provide support on quality audit as SME of DS automation/MES

作为原液生产部门自动化和MES SME支持工厂质量相关审计

Ÿ Lead and participate related change control, deviation and other actions as automation/MES SME

作为自动化和MES的SME,组织并参与自动化和MES相关的变更控制,偏差及其他行动项的执行。

Ÿ Responsible for preparation/revision to SOP, WI, and any associated documents related to DS automation and MES.

负责DS自动化和MES相关SOP,作业指导书及相关文件的制备和修订。

Ÿ Cooperate with related department, MST department, process department, engineer department, QA, QC and warehouse department in a good manner.

与相关部门,技术转移、研发、工程、QA、QC和仓库等部门保持良好的沟通协作。

Ÿ Complete other work item arranged by senior manager

完成上级领导安排的其他工作事项。

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