Biologist or Technician GMP Support Qualification / Validation | Biotechnologe (m/w/d)
BioNTech SE
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
Additional
- 2-year fixed-term contract
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