Validation and Qualification Specialist (FDA/GMP Focus) | Validierungs- und Qualifizierungsspezialist (m/w/d) mit FDA/GMP-relevanten Produkten

Job Summary

This critical role seeks a Validation and Qualification Specialist to ensure strict adherence to FDA and GMP regulations for pharmaceutical products and associated machinery. The specialist will be responsible for defining, monitoring, and executing qualification and validation projects, working closely with the Technical and IT departments to optimize existing procedures and maintain regulatory compliance. Key day-to-day tasks include conducting internal audits, managing the operational IT system, and overseeing the periodic maintenance, operation, and upkeep of critical equipment and plants. Candidates must possess multi-year experience in this specific validation and qualification field, coupled with a relevant technical or pharmaceutical background, such as a Pharmaceutical Technician or Industrial Technologist. Success requires a structured, conscientious, and team-oriented approach, along with fluent proficiency in both German and English.