- Work experience
- Software Development
Become a member of the BioNTech Family!
We aim to achieve life-changing successes for patients by being innovative, passionate and united, so get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
- Perform risk analysis at various levels, from process description to implementation details, together with development and validation team(s)
- Advise and support the development team in complying with regulatory requirements for software and development tools, adhering to internal development and release processes, and creating lean qualitative development documentation
- Advise and support process and system owners in ensuring validated status of in-house developed and deployed computerized systems and consistent documentation.
- Continuous review of development processes and associated standard operating procedures for compliance with laws and regulations, quality and efficiency and their adaptation in close cooperation with architects, validation and QA
What you have to offer.
- Successfully completed degree in computer science or comparable qualification
- Several years of work experience in the validation of computerized systems or quality assurance in same area in a regulated environment, ideally within the pharma or biotech industry
- Knowledge of regulations and guidelines relevant for implementation and validation of computerized systems in GxP environment (e.g. GAMP5, EU GMP Annex 11, FDA 21 CFR part 11, ICH, etc.) and ability to apply them
- Critical, analytical, risk-conscious and solution-oriented thinking as well as structured and precise way of working
- Knowledge and ideally experience in software development process
- Fast perception and high personal commitment within a fast paced environment
- Excellent communication skills and very good English skills, written and orally (German skills are also very desirable
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, Elisa Pabst will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you