[Remote] 6407 - Senior CSA Analyst – Plasma Systems & Site Enablement / Senor CSV Engineer

Note: The job is a remote job and is open to candidates in USA. Verista is a team of 500 experts collaborating with leading brands in the life science industry to address significant healthcare challenges. They are seeking a Senior CSA Analyst to lead computer software assurance activities for plasma-related applications, ensuring compliance with regulatory standards and supporting validation efforts for donor operations.ResponsibilitiesLead CSA activities for plasma-related applications and systems supporting regulated donor operations and business processesDevelop and execute risk-based validation strategies aligned with CSA principles and industry best practicesSupport validation planning, testing, execution, and release readiness for donor-facing and operational support applications, including personalized payment capabilitiesProvide CSA oversight for Donor Management System functionality, including enhancements, integrations, configuration changes, and site-specific deploymentsSupport validation and compliance activities for medical device-related systems and applicationsApply risk-based methodologies to assess system criticality, intended use, donor impact, data integrity requirements, and regulatory compliance obligationsEnsure validation activities align with applicable GxP requirements, quality standards, and regulatory expectationsEvaluate system changes, enhancements, and integrations to determine validation scope and testing requirementsSupport deviation assessments, defect triage, change control activities, and documentation review processesPartner with IT, Quality, Operations, CSA/CSV, business process owners, and project teams to define validation approaches and testing strategiesSupport system implementation activities including: Configuration verification, Integration testing, User Acceptance Testing (UAT), Data migration and data flow assessments, Release readiness evaluations, Operational readiness activitiesAssist with cross-functional readiness efforts for systems entering regulated plasma operations environmentsAuthor and/or review validation lifecycle documentation, including: Risk Assessments, Validation Plans, Requirements Specifications, Test Strategies and Protocols, Traceability Matrices, Summary Reports, Change ControlsEnsure documentation is complete, compliant, and inspection-readyGuide project teams on appropriate levels of testing rigor, evidence collection, and documentation based on system risk and business impactSkillsBachelor's degree in Engineering, Computer Science, Life Sciences, Information Systems, or a related disciplineSignificant experience in Computer System Validation (CSV) and/or Computer Software Assurance (CSA) within regulated industriesStrong understanding of GxP computerized systemsStrong understanding of risk-based validation methodologiesStrong understanding of CSA principles and practicesStrong understanding of software development and implementation lifecyclesExperience supporting regulated system implementations, enhancements, integrations, or change management activitiesDemonstrated ability to assess system risk, define validation strategies, and drive deliverables through review and approvalExperience collaborating with Quality, IT, Operations, business stakeholders, and technical teamsStrong knowledge of requirements managementStrong knowledge of test planning and executionStrong knowledge of traceabilityStrong knowledge of deviation managementStrong knowledge of validation reportingStrong knowledge of release readiness processesAbility to work independently and effectively across multiple concurrent project workstreamsExperience in plasma, blood products, biologics, pharmaceutical manufacturing, clinical operations, or medical device environmentsExperience with Donor Management Systems or comparable patient-facing, customer-facing, or operational platformsKnowledge of donor-facing, patient-facing, scheduling, enrollment, intake, payment, or workflow management applicationsExperience supporting medical device software, connected devices, instrumentation, equipment interfaces, or regulated data capture systemsExperience supporting new site startupsExperience supporting facility readiness initiativesExperience supporting innovation center buildoutsExperience supporting large-scale digital transformation programsExperience with system integrationsExperience with data migration activitiesExperience with interface testingExperience with data flow assessmentsExperience with reporting and downstream system impactsFamiliarity with 21 CFR Part 11Familiarity with EU Annex 11Familiarity with GAMP 5Familiarity with data integrity requirementsFamiliarity with risk-based assurance methodologiesBenefitsHigh growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementCompany OverviewVerista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing. It was founded in 1983, and is headquartered in Fishers, Indiana, USA, with a workforce of 501-1000 employees. Its website is https://www.verista.com/.Company H1B SponsorshipVerista has a track record of offering H1B sponsorships, with 1 in 2026, 7 in 2025, 4 in 2024, 13 in 2023, 6 in 2022, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role.