Computer System Validation (CSV) Quality Support Lead

Innova Solutions•Morristown, NJ

9h•Hybrid

About The Position

Innova Solutions is immediately hiring for a Computer System Validation (CSV) Quality Support Lead. This is a Full-Time Contract (W2) role for a duration of 4-6 months. The position is hybrid, located in Raritan, NJ, requiring the employee to work from the office 3 days a week. The CSV Lead will be responsible for leading and executing validation deliverables throughout the lifecycle, including risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release. A risk-based approach, considering GxP impact, patient/product risk, and data integrity, will be applied to define validation scope and testing depth. The role involves authoring and reviewing validation documentation such as Compliance Plans/Test Protocols, Risk Assessments, Requirements and Traceability Matrices (RTM), test scripts, test summaries, and compliance reports.

Requirements

Advanced knowledge of Computer Systems Validation (CSV).
Must be able to work on a W-2 basis.

Responsibilities

Lead and execute validation deliverables across the lifecycle: risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release.
Apply a risk-based approach (e.g., GxP impact, patient/product risk, data integrity) to define validation scope and testing depth.
Author/review validation documentation such as: Compliance Plan / Test Protocol (as applicable), Risk Assessments (e.g., system impact, functional risk), Requirements and Traceability Matrix (RTM), Test scripts, test summaries, and compliance reports.