System Engineer Digital Solutions Quality Assurance

Mainz, Germany   |   full time   |   Job ID: 9854 

 

 

In the role of System Engineer Digital Solutions Quality Assurance, you will are responsible for digitalization and continuous improvement of digitized business processes in collaboration with the specialists from the relevant departments. You will be the interface between the department and Business IT. Your tasks include:

 

  • Responsible for the digitalization concept of our Quality Assurance processes, such as Document Management, Training Management, Deviations, CAPA, and Batch Release Management.
  • Analysis and documentation of business processes for subsequent digitalization.
  • Responsibility for designing digitized business processes and implementing them in the respective digital systems.
  • Organization and facilitation of workshops with process owners and software providers to identify requirements, conduct risk analyses, and present prototypes.
  • Responsibility for implementing the developed solutions in collaboration with internal and external developers, as well as coordination with system owners.
  • Organization and execution of application support, change management, and deviation management.
  • Creation and execution of specification, testing, and training materials.
  • Conducting training sessions.

 

What you have to offer.

 

  • A completed degree in life sciences or computer science, or practical experience in a comparable field.
  • At least 3 years of relevant experience in the pharmaceutical industry, preferably in Quality Assurance or digitalization.
  • Experience with the implementation and operation of electronic Quality Management Systems (eQMS) and/or Release Management Systems.
  • Excellent understanding of pharmaceutical Quality Assurance processes.
  • Experience in the digitalization of Quality Assurance processes and computer system validation.
  • Experience in operating systems such as MasterControl, TrackWise, Veeva, or similar.
  • Experience in managing IT projects is a plus.
  • Understanding of data structures, Key Performance Indicators, data analysis, and visualization.
  • Fluency in English, German is a plus.

 

 

Your Benefits:

 

It's our priority to support you:

  • Your flexibility: flexible hours | vacation account  
  • Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
  • Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
  • Your health and lifestyle: Company bike
  • Your mobility: Job ticket | Deutschlandticket 
  • Your life phases: Employer-funded pension | Childcare 

 

 

Apply now - We look forward to your application!

 

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

 

Job ID 9854 (please always specify if you have any questions)   

 

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

 

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BioNTech, the story 

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.  

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.  

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. 

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!  

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