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Validation Engineer

Katalyst Healthcares & Life Sciences • Jersey City, NJ, US • published 2026-10-23 08:05:32.278065

Description

**Summary:** The Validation Engineer will support GMP validation activities and equipment qualification in a pharmaceutical or life sciences environment. The role involves developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, reviewing validation documentation, preparing reports, and supporting deviation investigations. The engineer will ensure compliance with cGMP, GAMP, 21 CFR Part 11, Good Documentation Practices (GDP), and data integrity requirements. **Roles and Responsibilities:** * Support equipment qualification and GMP validation activities, including IQ, OQ, and PQ. * Develop, execute, and review validation protocols, test scripts, and qualification documents. * Prepare validation summary reports and maintain accurate documentation in accordance with cGMP requirements. * Support validation deviation investigations, root cause analysis, and corrective and preventive actions (CAPA). * Ensure compliance with GAMP guidelines, 21 CFR Part 11, GDP, and data integrity standards. * Review validation records for completeness, accuracy, traceability, and regulatory compliance. * Collaborate with Quali...

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