6115 - Senior CSV Engineer / Senior Validation Engineer - Indianapolis
1 month ago
Job summary
The Senior Validation Engineer will lead and support Computer System Validation (CSV) remediation activities for laboratory systems.This role is critical to ensuring compliance of legacy and current laboratory systems through gap assessments, remediation planning,
and executions. The Senior CSV Engineer will perform gap analyses against current regulatory and internal validation standards,
develop and execute remediation strategies, supporting validation of 6–10 major laboratory systems,
author review and approve CSV documentation including validation plans protocols reports and risk assessments.
- Bachelor’s degree in Engineering Life Sciences or a related technical discipline
- Senior-level experience (5-10 years) in Computer System Validation (CSV) within a regulated GxP environment including legacy system remediation
Job description
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