System Engineer Digital Solutions Quality Assurance

System Engineer Digital Solutions Quality Assurance

Join to apply for the System Engineer Digital Solutions Quality Assurance role at BioNTech SE in Mainz, Germany. This is a full‑time position (Job ID: 9854).

Responsibilities

• 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

• 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

Apply to our Mainz, Germany location by sending your documents via our online form. For any questions, contact our talent acquisition team at +49 (0) (Monday‑Friday from 12 PM to 4 PM CET).

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’ and you will be informed accordingly by your BioNTech recruiter.

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