About the job you?re considering

We are seeking a Validation Lead to drive Computer System Validation (CSV) initiatives. This is an on-site role at client office in Chicago at least 4 days per week.

Your role

Plan & lead CSV activities for new implementations, enhancements, and periodic reviews, applying risk_based validation tailored to system criticality.
Define and deliver validation artifacts, including Validation Plans, IQ/OQ/PQ protocols, Test Scripts, Traceability Matrix, and Validation Summary Reports.
Establish and enforce traceability practices from requirements through testing and release; manage deviations, CAPAs, and re_tests.
Execute and oversee testing using HP ALM/Quality Center; track defects and results, assure coverage and objective evidence.
Ensure documentation meets Good Documentation Practices (GDP)

Your skills and experience

Computer System Validation (CSV) expertise, including hands_on IQ/OQ/PQ execution and risk_based validation approaches.
Strong working knowledge of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Proficiency with validation and testing tools: HP ALM/Quality Center, Veeva Vault (Quality/Docs), CodeBeamer (ALM), and Jira.
Solid understanding of SDLC and Agile methodologies, with rigorous traceability practices from requirements to release.
Excellent documentation and compliance skills ensuring GDP adherence; proven audit readiness and inspection support.
Strong analytical, problem_solving, and communication abilities to engage stakeholders, synthesize complex issues, and drive resolution.
Background in life sciences QA/IT/Validation; knowledge of Annex 15, ICH Q9/Q10, and related guidance will be an added advantage.