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

Senior CSA Analyst – Plasma Systems & Site Enablement

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

Responsibilities:

• 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.
• Apply risk-based methodologies to assess system criticality, intended use, donor impact, data integrity requirements, and regulatory compliance obligations.
• 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.
• 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.
• 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 data capture systems.
• Experience supporting:
  • New site startups
  • Facility readiness initiatives
  • Innovation center buildouts
  • Large-scale digital transformation programs
• Experience with:
  • System integrations
  • Data migration activities
  • Interface testing
  • Data flow assessments
  • Reporting and downstream system impacts
• Familiarity with:
  • 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • Data Integrity requirements
  • Risk-based assurance methodologies

Benefits:

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Pay:

• National (US) Range: $70,491 - $118,060 USD

Benefits:

• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement