Validation Expert | Validation Expert (m/w/d)

Job Summary

As a Validation Expert, you will play a crucial role in coordinating, planning, and executing the validation of aseptic processes, including media fills, microbiological shelf-life studies, and personnel qualifications. Your responsibilities will involve drafting and maintaining essential documentation such as Master Validation Plans, protocols, reports, and risk analyses, while also managing deviations and change requests. You will be responsible for evaluating and summarizing study results, contributing to regulatory submissions, and addressing inquiries from authorities. This position requires strong communication skills to represent complex technical topics in cross-functional project teams, internal and external meetings, and during audits and regulatory inspections. You will ensure compliance with internal, global, legal, and regulatory guidelines, and contribute to global initiatives within the company.