0079V6400 CSA Consultant/Senior Validation Engineer 2

Two River Consulting Partners•, PA

21h•Remote

About The Position

We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Pharmacovigilance (PV), Clinical, and Regulatory Affairs systems. The role works closely with Quality, IT, and business stakeholders to help ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures. The position is remote and offered on a C2C or W2 basis.

Requirements

5–8 years of 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, such as FDA, EMA, and ICH requirements, 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 Pharmacovigilance, 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, including URS, specifications, test plans, and test summaries, in alignment with ALCOA+ and Good Documentation Practices.
Oversee validation readiness and ensure prerequisites are met before 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 systems remain validated and compliant.
Support periodic reviews, 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 for risk-based compliance decisions.
Monitor regulatory inspection observations, internal audit findings, and compliance trends to identify process-improvement opportunities.
Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.