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

expertum GmbH - Niederlassung Biberach

Ochsenhausen, Baden-Württemberg, Deutschland
Published Sep 12, 2025
Full-time
No information

Job Summary

This role involves ensuring the quality and compliance of biopharmaceutical products by performing qualifications of complex computerized analytical systems according to BI LeVa principles. A key part of the job is planning, developing, validating, and verifying analytical methods for quality control, with a strong focus on physicochemical methods like pH, osmolality, conductivity, and particle testing. The expert will also contribute to the development and implementation of new analytical techniques within a GMP environment, support laboratory management, and handle tasks related to the Quality Management System. This position offers a chance to join a reputable company in the chemistry/pharmaceutical sector, leveraging extensive experience in analytical systems and method validation.

Required Skills

Education

Master's or Bachelor's degree in Biology, Biopharmacy, Biotechnology, Biochemistry, or Chemistry, or a scientific education with many years of relevant experience.

Experience

  • Several years of practical experience in qualifying analytical systems
  • Several years of practical experience in validating/verifying analytical methods
  • Experience in troubleshooting analytical issues
  • Experience in a GMP environment
  • Knowledge in virology is a plus

Languages

German (Fluent)English (Fluent)

Additional

  • Not specified