GMP Validation Engineer | GMP-Validierungsingenieur:in (all genders) 25081

Job Summary

This role involves supporting pharmaceutical and medical device projects in Großwallstadt, focusing heavily on validation and qualification within a GMP-regulated environment. The engineer will be responsible for drafting critical documentation, including User Requirements Specifications (URS), Factory Acceptance Tests (FAT), and Site Acceptance Tests (SAT) plans, and executing these tests. A core function is managing change control, which includes creating change requests and tracking them within the Change Management System. The position requires conducting thorough risk analyses, both product-related and safety-related, and developing qualification and validation plans for new and modified systems. Success in this role demands a strong technical understanding of highly automated production lines and solid compliance knowledge, particularly regarding medical regulations like FDA standards, alongside fluent German and good English communication skills.