CSA Consultant/Senior Validation Engineer

Job Description:

• 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:

• 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:

• Contracted employment
• C2C or W2 engagement options