BioNTech SE

QC运营助理工程师

BioNTech SE  •  Nantong, CN (Onsite)  •  1 month ago
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Job Description

岗位职责:

1、支持运营组相关检测工作,包括pH检测,外观及可见异物有关工作;

2、协助实验室仪器设备的验证、管理及维护工作;

3、负责实验室稳定性的管理及检测,并对相关数据进行汇总及趋势总结;

4、能够独立撰写、更新相关仪器和分析方法的SOP;

5、负责实验室试剂耗材的管理和维持现场6S;

6、严格遵守公司EHS安全法规,掌握安全工作技能和应急救援知识;

7、保持QC实验室的高GMP合规性和DI;

8、负责配合运营主管完成实验室发生的偏差、OOS/OOE/OOT等的调查,严格按照CAPA要求实施;

9、协助部门按时完成项目进度。

任职要求:

1、本科学历,生物化学,生物制药,药学等专业背景;

2、至少1年以上实验室经验,具有GMP药厂经验,熟悉实验室运营GMP要求优先考虑;

3、熟悉实验室样品管理工作,如稳定性样品和留样样品。

4、熟悉原辅料,包材取样和检测等工作。

5、熟悉实验室文件管理流程,主导文件的回收和发放。

6、熟悉现行版《中国药典》、《欧洲药典》、《美国药典》、GMP等相关法律法规;熟悉实验室常用仪器设备的使用,如pH计,天平等。

7、熟悉QC实验室OOS及偏差调查流程,主导调查工作。

8、熟悉企业现代化管理,熟练使用Office、Visio等办公软件。

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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