Validation Specialist II in Camarillo, CA

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The Validation Specialist II is responsible for developing, reviewing, and executing validation protocols to support manufacturing and quality operations while ensuring compliance with regulatory requirements. This role provides technical expertise and guidance on equipment, component, process, and system validation activities, collaborating closely with production and quality teams.

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. The Validation Specialist II ensures that change controls, records, and procedures align with current Good Manufacturing Practices (cGMP) and regulatory expectations.

This role also coordinates validation activities with cross-function...