6400- CSA Consultant / Senior Validation Engineer

Verista, Inc.•King of Prussia, PA

1d•$70,491 - $118,062•Remote

About The Position

Verista is 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. The company culture emphasizes empowering and supporting colleagues, committing to client success, having the courage to do the right thing, encouraging an inclusive environment, and continuously acquiring new skills. Verista is a team of 500 experts who collaborate with recognizable brands in the life science industry to solve business needs, empower growth and innovation, and help researchers and companies tackle pressing healthcare challenges. They provide innovative solutions and services that result from significant investment in people and capabilities, driven by world-class individuals who thrive in a team environment and share the mission to improve lives.

Requirements

5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
Hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
Strong understanding of CSA principles, CSV, and SDLC processes
Experience authoring and/or reviewing validation documentation
Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations
Ability to work independently in a fast-paced, matrixed environment
Strong communication skills and comfort interacting with Quality and business stakeholders

Nice To Haves

Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
Prior role as a Validation SME, CSA Lead, or Compliance Consultant
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms

Responsibilities

Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
Oversee validation readiness and ensure prerequisites are met prior to formal testing
Support change control, configuration management, and release activities
Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance
Provide guidance on CSA-based, risk-driven validation approaches
Conduct 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.