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

Job Overview: This position will be supporting ongoing plasma systems and applications used across regulated plasma operations. This individual will work with IT, Quality, business process owners, and project teams to ensure system changes, enhancements, and releases are appropriately assessed, tested, documented, and approved in accordance with CSA principles and applicable regulatory requirements. The ideal candidate is a senior-level CSA/CSV professional who can independently manage validation activities within a regulated plasma environment and quickly integrate into an established team and operating model.

Job Responsibilities: 

•    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.

Required Experience: 

•    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.

Preferred Experience:

•    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.