General Description:
Responsible for the lifecycle management of clinical manufacturing equipment & instrument.
Have strong working knowledge of oral solid dosage production equipment and engineer compliance, in-depth understanding of local and international HA regulations, such as NMPA, US FDA, EMA, GMPs, etc.
Essential Functions of the job:
61 Responsible for production equipment & instrument lifecycle management, including equipment & instrument qualification, maintenance, calibration, etc.
61 Responsible for qualification documentation preparation and review.
61 Support production equipment & instrument selection, procurement.
61 Coordinate engineering project management, including new clinical workshop/production line design and construction.
61 Responsible for warehouse equipment management, such as cooling chamber and freezer.
61 Responsible for clinical manufacturing workshop routine maintenance, correctly execute and continuous optimize the equipment preventive maintenance; be good at root cause finding out of machine break downs; develop continuous maintenance improvements.
61 Responsible for spare parts management, correctly execution of spare parts ordering, stock and consumption procedures.
61 Responsible for handling engineering related Change Control, Deviation, CAPA, and other quality events, ensure complied with SOP.
61 Responsible for equipment related SOPs as technical SME.
61 Collect and archive documents as required by SOP or WI.
61 Support clinical manufacturing related activities and other duties assigned by superior
61 To be a good team player, share knowledge, write technical procedures.
Education Required:
- Bachelor or Master degree in Engineering such as Mechanical Engineering, mechanical & Electrical, Automation, etc.
- CET-6 is required.
- Computer Skills: Proficient in computer skills including Outlook, Word, Excel, and PowerPoint
- Manufacturing and engineering related role is preferred.
- Capability of controlling and completing multiple issues with a clear sense of priority.
- Fluent English spoken and written, can read technical manuals, electrical diagrams.
百济神州全球胜任力
当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。
●团队协作
●提供并征求坦诚及可行的反馈
●自我认知
●兼容并蓄
●积极主动
●开拓精神
●持续学习
●拥抱变化
●结果导向
●分析性思维/数据分析
●卓越财务
●清晰沟通
BeiGene Global Competencies
When we exhibit our values of Patients ***, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
●Fosters Teamwork
●Provides and Solicits Honest and Actionable Feedback
●Self-Awareness
●Acts Inclusively
●Demonstrates Initiative
●Entrepreneurial Mindset
●Continuous Learning
●Embraces Change
●Results-Oriented
●Analytical Thinking/Data Analysis
●Financial Excellence
●Communicates with Clarity
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