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System engineer - digitalization (m/f/d)

Mainz
BioNTech SE
System Ingenieur
Inserat online seit: Veröffentlicht vor 23 Std.
Beschreibung

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. 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. 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. 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

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