Business Informatics Consultant (CSV/IT Validation) | Wirtschaftsinformatiker (m/w/d)

gempex GmbH - THE GMP-EXPERT

Mannheim, Baden-Württemberg, Deutschland
Published Dec 12, 2025
Full-time
No information

Job Summary

This role is for an experienced Business Informatics professional passionate about GMP compliance within the Life Sciences industry. The consultant will primarily focus on Computerized System Validation (CSV) compliance, advising clients on systems like ERP, databases, automation systems (MES, PLS, SPS), and ensuring validation according to GAMP 5 guidelines. Key responsibilities include preparing for and accompanying regulatory inspections, developing IT validation concepts, and conducting training and mentoring. The ideal candidate must possess a degree in Informatics or Business Informatics, at least 10 years of professional experience in IT/CSV consulting, and excellent proficiency in both German and English, coupled with a willingness to travel for diverse consulting projects.

Required Skills

Education

Completed degree in Informatics, Technical Informatics, or Business Informatics

Experience

  • At least 10 years in IT/CSV consulting
  • Professional experience in implementing and optimizing quality assurance systems
  • Experience in preparing and accompanying regulatory inspections

Languages

German (Fluent)English (Fluent)

Additional

  • Willingness to travel