[Remote] 6399- CSA Consultant / Senior Validation Engineer

Note: The job is a remote job and is open to candidates in USA. Verista is a company that partners with leading brands in the life sciences industry to address critical healthcare challenges. They are looking for an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance, Clinical, and Regulatory Affairs systems, ensuring that systems are compliant with applicable regulations and internal procedures.ResponsibilitiesProvide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platformsSupport system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspectiveDevelop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary ReportsReview and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation PracticesOversee validation readiness and ensure prerequisites are met prior to formal testingSupport change control, configuration management, and release activitiesPartner with Quality, System Owners, and Business Process Owners to ensure ongoing complianceProvide guidance on CSA-based, risk-driven validation approachesConduct periodic system compliance reviews, validation health checks, and lifecycle assessments to ensure continued validated state and ongoing regulatory complianceSupport periodic review activities including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenanceAssess the compliance impact of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentationReview and support vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisionsMonitor and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvementParticipate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational supportSkills5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domainsHands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domainsStrong understanding of CSA principles, CSV, and SDLC processesExperience authoring and/or reviewing validation documentationWorking knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectationsAbility to work independently in a fast-paced, matrixed environmentStrong communication skills and comfort interacting with Quality and business stakeholdersExperience with enterprise platforms supporting PV, Clinical, or Regulatory operationsPrior role as a Validation SME, CSA Lead, or Compliance ConsultantFamiliarity with electronic quality systems, change management tools, or application lifecycle management platformsBenefitsHigh 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.