Specialist Software Validation and IT Systems | Spezialist Softwarevalidierung & IT-Systeme (m/w/d)
ecoSPECS GmbH
Job Summary
This Specialist role focuses on ensuring the quality and regulatory compliance of software and IT systems within the pharmaceutical and life science sectors. The successful candidate will be responsible for the entire lifecycle of software validation, including planning, execution, and detailed documentation in GxP/GMP regulated environments. Daily tasks involve implementing specialized software solutions, adapting existing applications, and qualifying commercial off-the-shelf software based on user needs. A key aspect of the role is project coordination and leveraging modern tools like VBA, .NET, SQL, RPA, and Power Apps for system automation and maintenance. Furthermore, the specialist will explore and develop suitable AI solutions to optimize processes and support users with software and IT-related processes. Candidates must possess a degree or vocational training in IT or a related field, strong analytical skills, and an understanding of IT system administration and lifecycle management, ensuring high quality and regulatory adherence.
Required Skills
Education
Completed university degree or vocational training in Computer Science, Software Development, Business Informatics, or related IT field.
Experience
- Professional experience in planning, execution, and documentation of system validations
- Experience in software validation in regulated pharmaceutical environments (Advantageous)
- Experience or interest in the development and implementation of AI solutions
Languages
Additional
- Must be based in Biberach an der Riß or Ingelheim, Germany.
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