6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senior CSV Engineer

Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines Values: 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.

Responsibilities

: Computer Software Assurance Validation Lead CSA activities for plasma-related applications and systems supporting regulated donor operations and business processes. Develop and execute risk-based validation strategies aligned with CSA principles and industry best practices. Support validation planning, testing, execution, and release readiness for donor-facing and operational support applications, including personalized payment capabilities.

Provide CSA oversight for Donor Management System functionality, including enhancements, integrations, configuration changes, and site-specific deployments. Support validation and compliance activities for medical device-related systems and applications.

Requirements

, and regulatory compliance obligations.

, quality standards, and regulatory expectations.

Support deviation assessments, defect triage, change control activities, and documentation review processes. System Implementation Deployment Support Partner with IT, Quality, Operations, CSA/CSV, business process owners, and project teams to define validation approaches and testing strategies. Support system implementation activities including: Configuration verification Integration testing User Acceptance Testing (UAT) Data migration and data flow assessments Release readiness evaluations Operational readiness activities Assist with cross-functional readiness efforts for systems entering regulated plasma operations environments.

Specifications Test Strategies and Protocols Traceability Matrices Summary Reports Change Controls Ensure documentation is complete, compliant, and inspection-ready. Guide project teams on appropriate levels of testing rigor, evidence collection, and documentation based on system risk and business impact.

: Bachelor's degree in Engineering, Computer Science, Life Sciences, Information Systems, or a related discipline. Significant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within regulated industries. Strong understanding of: GxP computerized systems Risk-based validation methodologies CSA principles and practices Software development and implementation lifecycles Experience supporting regulated system implementations, enhancements, integrations, or change management activities.