Validation Expert | Validation Expert | M/W/D - Referenz 000987

Job Summary

As a Validation Expert, you will be responsible for coordinating, planning, and executing the validation of aseptic processes, including media fills, microbiological shelf lives, and personnel qualifications. Your daily tasks will involve creating, maintaining, and aligning master validation plans, protocols, reports, risk analyses, and regulations, as well as managing deviations and change requests. You will evaluate study results, support the creation of regulatory documents, and address agency inquiries. This role requires strong English language skills to represent complex technical topics in cross-functional project teams, meetings with internal and external partners, and during audits and regulatory inspections. You will also be responsible for aligning content with clients and interfaces, considering internal, global, legal, and regulatory requirements, and planning further studies and assessments in close collaboration with leadership.