Biologist or Technician GMP Support Qualification / Validation | Biologe (m/w/d)
BioNTech SE
Job Summary
This role at BioNTech IMFS is crucial for the production of cellular drugs and gene therapeutics for clinical trials. The successful candidate will be responsible for planning, executing, and documenting the (re-)qualification of cleanroom facilities and process equipment, including computer system validations. A key part of the role involves ensuring all cleanroom facilities comply with current GMP requirements and creating or revising Standard Operating Procedures (SOPs) related to cleanroom technology. The position requires collaboration with interdisciplinary teams to identify and implement technical improvements, analyze and resolve technical issues, and support the handling of deviations, changes, and CAPA measures. This is an excellent opportunity for a detail-oriented professional with a strong background in GMP regulations and cleanroom operations.
Required Skills
Education
Completed scientific degree or degree in biotechnology or process engineering, or comparable qualification.
Experience
- Several years of practical experience in (re-)qualification under GMP (URS, RA, DQ, etc.) of devices and systems or computer system validations
- Professional experience with cleanroom facilities and process equipment
Languages
Additional
- Not specified
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