BioNTech SE

LIMS/Instrument工程师

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

岗位职责:

  • 参与LIMS系统的需求调研、选型、部署及配置,协调IT、QA与QC团队完成系统上线;
  • 主导/支持LIMS的验证(IQ/OQ/PQ),参与编写验证文件(URS、FRS、测试脚本等),确保符合GMP要求;
  • 定制化开发电子工作流(如样品管理、检验结果录入、OOS流程),优化实验室操作效率;
  • 负责LIMS日常运维,包括用户权限管理、数据备份、审计追踪审核及故障排查;
  • 管理系统升级/变更控制,评估变更影响并执行再验证(如适用);
  • 为QC人员提供LIMS操作培训,编写SOP和用户手册;
  • 确保LIMS符合数据完整性要求(如审计追踪、电子签名、防篡改),支持国内外审计(FDA/EMA/NMPA);
  • 定期审核系统日志,识别并纠正潜在数据风险(如未授权操作、数据延迟录入);
  • 配合完成计算机化系统周期性回顾,确保系统持续合规;
  • 对接IT部门解决系统接口问题(如与ERP、CDS的集成);
  • 协助QC团队处理OOS/OOT/偏差中的LIMS数据调查;
  • 负责QC设备设施等日常管理,包括维护设备清单和状态,组织设备的再确认和再计量等,支持设备相关的调查等;
  • 领导安排的其它相关工作。

任职要求:

  • 本科及以上学历,药学、生物技术、分析化学等相关专业;
  • 4年以上GMP生物制药企业的相关工作经验,1年以上LIMS运营工作经验;
  • 具备较好的英语读写的能力;
  • 熟悉国内外设备和系统确认相关的法规或指南,如GAMP5;
  • 人员项目管理能力强,沟通表达能力强;
  • 较强的独立思考和分析能力,能根据实际情况提出方案;
  • 工作认真负责、考虑问题细致、有良好的团队合作精神。
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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Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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