Senior CSA Analyst – Plasma Systems

About the role

We are seeking a Senior CSA Analyst / Senior Validation Engineer to support computerized systems and applications used in regulated plasma operations. The role will lead risk-based CSA/CSV activities for system changes, enhancements, integrations, and releases while ensuring compliance with GxP and applicable regulatory requirements.

The ideal candidate will independently manage validation activities, develop and review CSA deliverables, execute testing, manage deviations and defects, and work closely with IT, Quality, business process owners, and technical teams.

Responsibilities

• Lead and execute CSA/CSV activities for regulated computerized systems.
• Develop and review validation plans, risk assessments, requirements, test scripts, traceability, and summary reports.
• Assess system and change risks and define appropriate testing and documentation strategies.
• Support system changes, enhancements, integrations, configurations, and releases.
• Manage test execution, defects, deviations, and release readiness.
• Ensure validation activities comply with GxP, quality procedures, and regulatory expectations.
• Provide risk-based CSA guidance and manage multiple validation activities independently.

Requirements

• Senior-level CSV/CSA experience in Life Sciences, Pharma, Biotech, Plasma, Blood Products, or a regulated environment.
• Strong knowledge of Computer Software Assurance (CSA), GxP, and risk-based validation.
• Experience with requirements, risk assessments, testing, traceability, deviations, and validation reporting.
• Strong cross-functional collaboration with IT, Quality, and business teams.
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity.

Preferred Qualifications

• Experience with plasma/blood product systems, donor management, plasma collection, system integrations, interfaces, data flows, or master data.