The role requires strong hands-on experience executing IQ, OQ, PQ, and test scripts; documenting objective evidence; managing protocol exceptions and deviations; and ensuring laboratory systems are fit for intended use and compliant with cGMP, data integrity, 21 CFR Part 11, EU Annex 11, and GAMP 5 expectations. Knowledge of laboratory workflows, analytical testing processes, sample management, instrument control, audit trails, electronic records, electronic signatures, reporting, calculations, and data review practices is strongly preferred.