Essential: Bachelor's degree in Engineering (preferred), Computer Science, Biotechnology, or a related technical discipline; minimum seven years of validation experience in a regulated pharmaceutical, biotechnology, medical-device, or comparable GMP environment; demonstrated experience with CQV for GMP equipment, utilities, facilities, or manufacturing systems; experience supporting CSV throughout the system lifecycle; and a strong record of authoring, reviewing, and approving validation documentation. Strong working knowledge of GMP and GDP requirements, ISPE GAMP 5, risk-based validation, data integrity, 21 CFR Part 11, EU GMP Annex 1, change control and CAPA systems, the DQ/IQ/OQ/PQ lifecycle, Validation Master Plans, and validation maintenance programs.