Validation Specialist II

Key responsibilities include conducting computer system validations to ensure adherence to GxP regulations, including 21 CFR Parts 210, 211, and 820, as well as compliance with Good Automated Manufacturing Practice (GAMP) standards. Ensures that change controls, records, and procedures align with current Good Manufacturing Practices (cGMP) and regulatory expectations. Coordinates validation activities with cross-functional teams to minimize impact on production schedules while ensuring timely execution. Responsible for authoring validation protocols, final reports, and technical summaries for the qualification and release of equipment, systems, instruments, components, and utilities. Support continuous improvement initiatives and provide mentorship to junior validation staff.