TL;DR

Validation Lead (CSV): Driving and leading Computer System Validation (CSV) initiatives for new implementations and enhancements with an accent on risk-based validation, GxP regulations, and documentation practices. Focus on defining validation artifacts, establishing traceability, executing testing with HP ALM/Quality Center, and ensuring GDP adherence.

Location: On-site at client office in Chicago, IL, at least 4 days per week.

Salary: $86,900 - $192,460

Company

%hirify_global% is a global business and technology transformation partner with 340,000 team members across more than 50 countries, helping organizations unlock the value of technology.

What you will do

Plan and lead CSV activities for new implementations, enhancements, and periodic reviews.
Define and deliver validation artifacts including Validation Plans, IQ/OQ/PQ protocols, Test Scripts, Traceability Matrix, and Validation Summary Reports.
Establish and enforce traceability from requirements through testing and release; manage deviations, CAPAs, and re-tests.
Execute and oversee testing using HP ALM/Quality Center, tracking defects and assuring coverage.
Ensure documentation meets Good Documentation Practices (GDP).

Requirements

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 like HP ALM/Quality Center, Veeva Vault, CodeBeamer, and Jira.
Solid understanding of SDLC and Agile methodologies with rigorous traceability practices.
Excellent documentation and compliance skills, ensuring GDP adherence and audit readiness.
Background in life sciences QA/IT/Validation.

Culture & Benefits

Comprehensive benefits package including paid time off (vacation, holidays, personal days, sick leave).
Medical, dental, and vision coverage (or provincial healthcare coordination in Canada).
Retirement savings plans (e.g., 401(k) in the U.S.).
Life and disability insurance.
Employee assistance programs.
Opportunity to shape your career and be inspired by a collaborative global community.