0079V6400 CSA Consultant/Senior Validation Engineer 2

0079V6400 CSA Consultant/Senior Validation Engineer 2
We 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.

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
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.
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.
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
~ FDA, EMA, ICH) and data integrity expectations
~ Strong communication skills and comfort interacting with Quality and business stakeholders

Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms
Remote