Validation Test Analyst (CSV/CSA)

As a Validation Test Analyst (CSV/CSA) , you will make an impact by ensuring regulated systems meet compliance, quality, and validation requirements within Life Sciences environments. You will be a valued member of the quality and validation team, collaborating closely with business stakeholders, project teams, testing teams, and regulatory compliance partners to support Computer System Validation (CSV) and Computer Software Assurance (CSA) initiatives.

In this role, you will:

• Execute validation and testing activities in accordance with approved customer processes, procedures, and regulatory requirements.

• Design, develop, and execute validation test scripts and supporting validation deliverables.

• Analyze functional and business requirements, estimate testing efforts, and contribute to validation planning and strategy development.

• Support the preparation, review, and maintenance of testing and Software Lifecycle (SLC) documentation.

• Coordinate defect triage activities, investigate test results, and collaborate with cross-functional teams to drive issue resolution.

• Ensure timely delivery of high-quality validation testing activities while maintaining compliance standards.

• Provide regular project updates and status reporting through daily, weekly, and monthly governance forums.

• Support validation initiatives involving Documentum (OpenText D2) and other regulated platforms.

Work model

We strive to provide flexibility wherever possible. Based on this role’s business requirements, this is a remote position open to qualified applicants in Chicago-IL. Regardless of your working arrangement, we are here to support a healthy work-life balance though our various wellbeing programs.

The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.

• Strong understanding of GAMP categorization , Computer System Validation (CSV) , Computer Software Assurance (CSA) methodologies, and validation lifecycle processes.

• Experience working with 21 CFR Part 11 requirements and risk-based validation approaches in regulated environments.

• Hands-on experience with Documentum (OpenText D2) .

• Proven experience in validation test design, execution, defect management, and