Biologist or Technician GMP Support Qualification / Validation | Biotechnologe (m/w/d)

BioNTech SE

Idar-Oberstein, Rheinland-Pfalz, Deutschland
Published Sep 25, 2025
Full-time
No information

Job Summary

This role involves planning, executing, and documenting the (re-)qualification of cleanroom facilities and process equipment, including computer system validations. The professional will ensure all cleanroom facilities meet current GMP requirements, create and revise Standard Operating Procedures (SOPs), and collaborate with interdisciplinary teams to identify and implement technical improvements. Key responsibilities also include analyzing and resolving technical issues in cleanroom facilities and process equipment, as well as supporting the handling of deviations, changes, and CAPA measures. The ideal candidate will possess a strong technical understanding, knowledge of ERP systems, and extensive experience with GMP regulations, making this a crucial role for maintaining high quality standards in a regulated environment.

Required Skills

Education

Degree in Natural Sciences, Biotechnology, Process Engineering, or comparable qualification

Experience

  • • Several years of practical experience in (re-)qualification under GMP (URS, RA, DQ, etc.) of equipment and facilities or computer system validations

Languages

German (Fluent)English (Fluent)

Additional

  • 2-year fixed-term contract