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.

We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Senior CSA Analyst – Plasma Systems Site Enablement 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.

Compliance Risk Management

Apply risk-based methodologies to assess system criticality, intended use, donor impact, data integrity requirements, and regulatory compliance obligations.

Ensure validation activities align with applicable GxP requirements, quality standards, and regulatory expectations.

Evaluate system changes, enhancements, and integrations to determine validation scope and testing requirements.

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.

Documentation Quality Deliverables

Author and/or review validation lifecycle documentation, including:

Risk Assessments

Validation Plans

Requirements 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.

Requirements:

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.

Demonstrated ability to assess system risk, define validation strategies, and drive deliverables through review and approval.

Experience collaborating with Quality, IT, Operations, business stakeholders, and technical teams.

Strong knowledge of:

Requirements management

Test planning and execution

Traceability

Deviation management

Validation reporting

Release readiness processes

Ability to work independently and effectively across multiple concurrent project workstreams.

Preferred Qualifications

Experience in plasma, blood products, biologics, pharmaceutical manufacturing, clinical operations, or medical device environments.

Experience with Donor Management Systems or comparable patient-facing, customer-facing, or operational platforms.

Knowledge of donor-facing, patient-facing, scheduling, enrollment, intake, payment, or workflow management applications.

Experience supporting medical device software, connected devices, instrumentation, equipment interfaces, or regulated …