System Engineer, Digital Solutions Quality Assurance | Biologist (m/w/d)
BioNTech SE
Job Summary
This System Engineer role is vital for driving the digitalization and continuous improvement of Quality Assurance (QA) processes within the pharmaceutical sector. The successful candidate will serve as the interface between QA departments and Business IT, taking responsibility for the digitalization concept encompassing critical systems like Document Management, CAPA, Training Management, and Batch Release. Day-to-day tasks involve analyzing and documenting business processes, designing digital solutions, facilitating workshops with stakeholders and software vendors, and coordinating implementation with developers. Key requirements include a life sciences or computer science degree, coupled with at least three years of pharmaceutical QA or digitalization experience, and expertise in electronic Quality Management Systems (eQMS) and computer system validation. This position offers the opportunity to modernize essential quality systems while requiring fluency in English.
Required Skills
Education
Completed degree in life sciences or computer science, or practical experience in a comparable field
Experience
- At least 3 years of relevant experience in the pharmaceutical industry
- Professional experience in Quality Assurance or digitalization
- Experience with the implementation and operation of electronic Quality Management Systems (eQMS) and/or Release Management Systems
- Experience in operating systems such as MasterControl, TrackWise, Veeva, or similar
- Experience in managing IT projects (a plus)
Languages
Additional
- Excellent understanding of pharmaceutical Quality Assurance processes
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