Validation Engineer

Job DescriptionRoles & Responsibilities: Develop and manage GxP system lifecycle documentation, including Validation Plans, Testing Protocols, Traceability Matrix, Validation Reports Work closely and communicate with project teams to analyze requirements and build test protocols Author and execute test protocols to support computer system validation using Client Quality Center Document bugs/defects using Client Quality Center Follow FDA 21 CFR Part 11 regulations, GxP regulations, Client policies/ procedures, GAMP5 best practices Proficient in the use of Client Quality Center Communicate issues that could impact scope or timeline to validation team leadership Complete all assigned training prior to due dates Is detail oriented Works under general supervision; typically reports to a manager Enter project task time in Clarity Requires a bachelor''s degree and 4-7 years of experience

Created: 2025-11-15