CSA Consultant/Senior Validation Engineer

ilb Consulting Services

. Provide CSA / CSV subject matter expertise across Pharmacovigilance, Clinical, and Regulatory Affairs platforms .

Posted 10/29/2026contractRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CSA and CSV within Pharmacovigilance, Clinical, and Regulatory Affairs, ensuring compliance through effective validation documentation and risk assessments. Proficient in managing GxP systems and supporting system implementations while collaborating with cross-functional teams.

Highest-signal resume keywords

CSA PrinciplesCSV DocumentationGxP RegulationsValidation DocumentationChange Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation PlansRisk AssessmentsTraceability MatricesValidation Summary ReportsLifecycle DocumentationCompliance ReviewsData Integrity EvaluationsAudit Trail AssessmentsSystem Inventory MaintenanceRegulatory Inspection Monitoring

Soft Skills

Strong Communication SkillsIndependent Work AbilityStakeholder Interaction

Tools & Technologies

Electronic Quality SystemsChange Management ToolsApplication Lifecycle Management Platforms

Industry Keywords

PharmacovigilanceClinical AffairsRegulatory AffairsGxP SystemsFDAEMAICHALCOA+Good Documentation PracticesValidation SME

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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 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
Support user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance
Assess compliance impacts of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation
Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation
Monitor regulatory inspection observations, internal audit findings, and compliance trends to identify process improvements
Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and operational support

Requirements

What you’ll need

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, including FDA, EMA, and 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
Preferred: experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
Preferred: prior role as a Validation SME, CSA Lead, or Compliance Consultant
Preferred: familiarity with electronic quality systems, change management tools, or application lifecycle management platforms

Benefits

Comp & perks

Contracted employment
C2C or W2 engagement options