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

Job Summary

This expert role focuses on ensuring the quality and compliance of analytical systems and methods within the biopharmaceutical sector. Day-to-day responsibilities include executing the qualification of complex computerized analysis systems following established principles (BI LeVa), and planning, developing, validating, and verifying analytical methods for quality control of biopharmaceutical products. A core focus is on physicochemical methods such as pH, osmolality, conductivity, and particle testing (visual and sub-visual). The expert will contribute to the development and implementation of new analysis techniques in a GMP environment and assist laboratory management with planning, coordination, and evaluation of analytical activities. Successful candidates must possess a relevant science degree (Master's/Bachelor's) or equivalent experience, extensive practice in system qualification and method validation, and excellent German and English skills, making this a challenging and rewarding position in a leading chemical/pharmaceutical company.