Validation & Qualification Expert – Analytical Methods & GMP – Biopharma | Validation & Qualification Expert (m/w/d) – Analytische Methoden & GMP – Biopharma

Job Summary

This role involves ensuring the quality and reliability of biopharmaceutical products through the validation and qualification of analytical methods and systems. The expert will be responsible for conducting qualifications of complex computerized analytical systems following BI LeVa principles and for planning, developing, validating, and verifying analytical methods, with a focus on physicochemical methods like pH, osmolality, conductivity, and particle testing. A key part of the job is contributing to the development and implementation of new analytical techniques within a GMP environment and supporting laboratory management in planning and evaluating analytical activities. The position requires strong expertise in quality management systems, troubleshooting analytical issues, and excellent communication skills in both German and English.