Senior CSA Analyst – Plasma Systems / Senior Validation Engineer

Verista, Inc.

Senior CSA analyst validating plasma systems and releases for Verista’s life sciences clients. Assessing risk, testing changes, and documenting compliance with GxP and regulatory requirements.

Posted 8/17/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesSenior💰 $78,925 - $118,060 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Computer Software Assurance (CSA) and validation within regulated environments, particularly in life sciences and biotechnology. Proficient in risk-based validation principles, system integrations, and compliance with regulatory standards such as GxP and 21 CFR Part 11.

Highest-signal resume keywords

Senior-Level CSV/CSA ExperienceGxP Computerized Systems KnowledgeRisk-Based Validation Strategy DevelopmentTest Planning and ExecutionCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk AssessmentsValidation PlansTest StrategiesTraceabilityChange Control DocumentationDefect ManagementValidation ReportingRelease ReadinessSystem Integration ReviewData Integrity

Soft Skills

Independent ManagementPractical Guidance

Industry Keywords

Life SciencesBiotechnologyPharmaceuticalPlasma OperationsBlood Products21 CFR Part 11EU Annex 11GAMP 5Regulated EnvironmentDonor Management

About the role

Key responsibilities & impact

Lead and execute CSA activities for computerized systems supporting Plasma operations
Support validation of system changes, enhancements, integrations, configurations, and releases
Assess system and change risk and define the appropriate CSA strategy, testing approach, and documentation level
Develop and/or review 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
Review system integrations, interfaces, data flows, and configuration changes
Ensure validation activities align with procedures, quality system requirements, and regulatory expectations
Provide practical CSA guidance to project teams and determine appropriate evidence and testing rigor based on risk
Independently manage assigned CSA activities and progress deliverables through review and approval according to project timelines

Requirements

What you’ll need

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

Benefits

Comp & perks

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
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
High growth potential and people-focused culture