6400- CSA Consultant / Senior Validation Engineer

DescriptionVerista’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 colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 expertiseOverviewWe are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. This role will work closely with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures.Key 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 compliance.Support periodic review activities including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.Assess the compliance impact of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation.Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisions.Monitor and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvement.Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.Required Experience & Qualifications5–8 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 stakeholdersPreferred ExperienceExperience 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 platformsFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.*Verista is an equal opportunity employer.National (US) Range$70,491—$118,062 USDBenefitsWhy Choose Verista?High 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 insuranc