Quality Engineer II - Validation
Core
Independent quality partner providing oversight and guidance across validation, qualification, and data integrity activities to ensure regulatory compliance for equipment, facilities, utilities, manufacturing processes, and computerized systems.
Role type
Senior IC Quality Engineer (Validation & Data Integrity)
Builds
Validated and qualified equipment, facilities, utilities, manufacturing processes, cleaning programs, and computerized systems
Domain
Healthcare manufacturing / cGMP-regulated industry
Required skills
cGMP regulations, GAMP 5 principles, 21 CFR Part 11, ALCOA+ data integrity, risk-based quality management, validation protocols review, change controls, deviation analysis, data integrity assessments
Preferred skills
eQMS platforms, audit trail review, regulatory inspection support, ASQ CQE/CSQE/CQA certification, continuous improvement coaching
Technologies
eQMS platforms, computerized systems
Responsibilities
Provide quality assurance leadership for validation and qualification projects from risk assessment to closure; Review and approve validation, qualification, and lifecycle documentation for compliance; Evaluate change controls and revalidation strategies; Assess and approve eQMS records; Lead data integrity assessments and compliance reviews; Analyze trends in validation deviations and quality metrics; Support regulatory inspections and audits
Seniority
Mid-Senior, hands-on IC