BioNTech SE

工艺设备工程师

BioNTech SE  •  Nantong, CN (Onsite)  •  2 months ago
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Job Description

岗位职责:

  • 负责公司相关设备全生命周期管理工作,参与设备的选型、采购、开箱、搬运、安装、调试、验收与确认、闲置设备的封存、调拨、报废管理等工作;
  • 负责设备的编码、台账、固定资产与档案管理工作;
  • 根据公司生产计划,结合人员、设备情况编制设备检查与维护计划,并按计划监督维护维修工作,保质、保量地完成任务;
  • 参与设备故障诊断工作,定期对设备运行状况进行数据收集与分析;
  • 负责公司与工艺设备改造相关的技术工作,对生产设备持续性改进方案提出合理化建议,并对改造工作统一管理;
  • 负责原液生产、制剂灌装、包装线等工艺设备相关的维护维修及安全工作,确保人员、设备、物料安全;
  • 负责工艺设备相关的质量变更、偏差起草及调查方面的工作;
  • 参与新项目工艺设备URS、FAT、SAT、IQ、OQ制定、审核工作,给出合理审核意见;
  • 通过团队协作,完成设备效能,维修计划,可靠性提升,库存管理及维护的全面完善;
  • 负责工艺设备相关供应商的对接与管理,确保内部流程的合规性;
  • 完成上级领导交办的其他任务。

任职要求:

  • 本科以上学历,机电一体化、机械、电气自动化或制药工程相关专业;
  • 5年以上制药行业工作经验,有无菌制药设备(ORABS、隔离器等)或自动包装线/灯检机维护维修经验者优先;
  • 熟悉GMP设备管理体系,可独立完成偏差、变更、SOP等文件的起草;
  • 可熟练使用CAD、Office等办公软件;
  • 较强的团队意识,精诚合作、高效服务,工作态度端正、责任心强;
  • 思维清晰,有良好的组织、协调沟通能力,吃苦耐劳;
  • 具备一定的英文读写能力者优先;
BioNTech SE

About BioNTech SE

Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.

BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.

BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.

Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html

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🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html

Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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