CSA Consultant/Senior Validation Engineer

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🔥 4 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

👷🏻‍♀️ Engineer

👻 Ghost score 15%

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ilb Consulting Services

WebsiteLinkedInAll Job Openings

11 - 50 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ilb Consulting Services is a premier consulting group that specializes in aligning business and IT needs with top-level talent. They focus on providing expert consulting services to both candidates and clients, ensuring the best matches and solutions for various professional requirements.

📋 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

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