Computer Systems Validation Engineer (CSV/CSA)
Core
Plan, develop, and execute computer system validation activities for manufacturing and automation systems to ensure compliance with regulatory standards.
Role type
Senior Computer Systems Validation Engineer (CSV/CSA)
Builds
Validated software and hardware systems for manufacturing and automation
Domain
Life Sciences / Manufacturing / Regulatory Compliance
Required skills
Computer System Validation (CSV/CSA), Test Case Development, Risk Assessment, Regulatory Guidelines (FDA, GxP, GAMP5), Documentation, Quality Systems
Preferred skills
Laboratory instruments, Bio process equipment, Consulting experience
Technologies
FDA, GxP, GAMP5
Responsibilities
Author validation plans, test cases, protocols, and reports; Review system requirements and design documents; Perform risk assessments; Collaborate with cross-functional teams; Maintain documentation
Seniority
Mid-level Senior, hands-on IC