BioNTech SE

CSV & Process Senior Specialist

BioNTech SE  •  Nantong, CN (Onsite)  •  4 months ago
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Job Description

岗位职责:

  • 负责工厂计算机化系统验证体系的维护;
  • 负责建立工厂计算机化系统验证策略和计算机化系统验证计划,并确保顺利实施;
  • 负责相关的计算机化系统差距分析和补充验证;
  • 负责计算机化系统验证风险评估、验证方案和报告的编制;
  • 负责计算机化系统验证的协调、推进和实施;
  • 协助处理计算机化系统相关的质量事件,包括但不限于偏差、变更、CAPA等;
  • 计算机化系统验证相关法规/指南的培训讲解;
  • 协助分析仪器计算机化系统验证;
  • 完成上级领导交付的其他工作。

任职要求:

  • 本科及以上学历,信息技术或制药相关专业;
  • 制药企业验证工作满6年以上,有计算机化系统验证相关经验;
  • 制药行业验证相关工作6年以上;
  • 良好的英文听说读写能力。
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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