6480 - Senior CSA Analyst – Plasma Systems / Senior Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

•    Lead and execute CSA activities for computerized systems supporting Plasma operations.
•    Support validation of system changes, enhancements, integrations, configurations, and releases within the Plasma functional area.
•    Assess system and change risk and define the appropriate CSA strategy, testing approach, and level of documentation.
•    Develop and/or review CSA deliverables including risk assessments, validation plans, requirements, test strategies, test scripts, traceability, summary reports, and change control documentation.
•    Apply risk-based CSA principles based on intended use, process impact, donor impact, data integrity, and system criticality.
•    Partner with IT, Quality, business process owners, technical teams, and other stakeholders throughout the system lifecycle.
•    Support test execution, defect and deviation management, documentation review, and release readiness activities.
•    Review system integrations, interfaces, data flows, and configuration changes as applicable.
•    Ensure validation activities align with applicable procedures, quality system requirements, and regulatory expectations.
•    Provide practical CSA guidance to project teams and help determine appropriate evidence and testing rigor based on risk.
•    Manage assigned CSA activities independently and ensure deliverables progress through review and approval according to project timelines.

•    Senior-level CSV/CSA experience within life sciences, biotechnology, pharmaceutical, plasma, blood products, or another regulated environment.
•    Strong understanding of GxP computerized systems, Computer Software Assurance, and risk-based validation principles.
•    Experience supporting regulated application changes, enhancements, integrations, and releases.
•    Ability to assess system risk and independently define and execute an appropriate validation strategy.
•    Strong experience with requirements, risk assessments, test planning, test execution, traceability, deviation management, validation reporting, and release readiness.
•    Experience working cross-functionally with IT, Quality, business process owners, and technical teams.
•    Ability to operate independently within an established program and manage multiple concurrent validation activities.

•    Direct experience supporting Plasma or blood products systems and business processes.
•    Experience with applications supporting donor management, donor operations, plasma collection, or related regulated processes.
•    Experience with system integrations, interfaces, data flows, master data, or reporting within a regulated environment.
•    Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity expectations, and risk-based assurance practices.