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 a biopharmaceutical environment. Day-to-day responsibilities include executing the qualification of complex computerized analytical systems following BI LeVa principles, and planning and validating/verifying analytical methods for biopharmaceutical quality control, specifically focusing on physicochemical methods (e.g., pH, osmolality, conductivity, particle testing). The expert will contribute to the development and implementation of new analytical techniques within a GMP framework and support laboratory management with planning and evaluation of analytical activities. Key requirements include a relevant science degree (Master/Bachelor) and several years of practical experience in system qualification and method validation. Success in this position requires strong knowledge of physicochemical methods, troubleshooting abilities, and excellent German and English language skills, making it an attractive opportunity for a motivated professional seeking a challenging role in pharmaceutical quality assurance.