Jobs → QA & Testing → Quality Assurance Validation Engineer

About the Role We are looking for a Quality Assurance Validation Engineer to join our team. This role focuses on ensuring compliance with GMP-regulated environments through validation and quality oversight. Key Responsibilities • Review and approve validation plans, risk assessments, protocols, traceability matrices, and final reports • Provide quality oversight of equipment, utilities, automated systems, computerized systems, and laboratory systems • Support audits, regulatory inspections, and inspection readiness • Ensure compliance with cGMP, GDP, GAMP, data integrity, and 21 CFR Part 11 Requirements • 10+ years of experience in QA, CQV, CSV, or validation within a GMP-regulated environment • Experience reviewing and approving validation plans, risk assessments, protocols, traceability matrices, and final reports • Strong knowledge of cGMP, GDP, GAMP, data integrity, and 21 CFR Part 11 • Experience with deviations, investigations, CAPAs, change controls, and validation exceptions • Understanding of audit trails, electronic records, access controls, and compliance requirements • Experience with Kneat, ValGenesis, Veeva, or similar systems • Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field Important: Candidates must be currently based in the USA and available to work onsite in MA.