Validation Consultant – Computer System Validation (CSV/CSA)

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Validation Consultant – Computer System Validation (CSV/CSA) based in United States.** This role offers the opportunity to become a key technical authority supporting life science manufacturers through complex validation and compliance initiatives. The Validation Consultant will help shape validation strategies, develop scalable frameworks, and ensure technology solutions meet strict regulatory expectations. Working across ERP, quality management, and manufacturing platforms, this position combines technical expertise with consulting impact. The successful candidate will contribute to inspection-ready validation programs while partnering with clients across regulated environments. This is a senior-level opportunity for someone passionate about quality systems, risk-based validation, and operational excellence. The role provides the chance to influence best practices, mentor others, and support the growth of a specialized consulting practice. ### Accountabilities: The Validation Consultant will serve as a senior expert in computer system validation and computer software assurance, leading validation initiatives, developing reusable frameworks, and ensuring compliance across regulated life science technology environments. - Establish and maintain validation strategies, standards, and methodologies aligned with cGxP, GAMP 5 Category 4, CSA principles, EU Annex 11, 21 CFR Part 11, and ALCOA+ data integrity expectations. - Develop, maintain, and improve validation toolkits for ERP, quality management, and supporting software platforms, including requirements templates, risk assessments, traceability matrices, and qualification scripts. - Create and expand validation frameworks for new software platforms, modules, and technology solutions as consulting services evolve. - Analyze software releases, enhancements, and system changes to determine validation impact, risk levels, and required documentation updates. - Lead complete validation engagements, including planning, documentation, protocol execution support, evidence review, deviation management, and validation summary reporting. - Provide hands-on validation guidance to client teams, supporting successful adoption of compliant processes and systems. - Adapt validation deliverables to meet client-specific procedures, quality management systems, and software development lifecycle requirements. - Produce clear, accurate, and audit-ready validation documentation supporting regulatory inspections and internal quality reviews. - Collaborate with QA, IT, business stakeholders, and client teams to ensure effective validation execution. - Mentor junior consultants and contribute to the development of managed validation services and consulting capabilities. ## Requirements: The ideal candidate is an experienced validation professional with deep knowledge of regulated life science environments, strong technical documentation skills, and the ability to independently manage complex client engagements. This role requires expertise in risk-based validation approaches, regulatory compliance, and collaboration across technical and business teams. - 10+ years of experience in computer system validation (CSV) or computer software assurance (CSA) within life science manufacturing environments. - Strong knowledge of cGxP regulations, GAMP 5 Category 4 systems, 21 CFR Part 11, EU Annex 11, ALCOA+, and CSA methodologies. - Familiarity with 21 CFR Part 820/QMSR and ISO 13485 quality management system requirements. - Demonstrated experience creating and maintaining validation documentation, including URS/FRS templates, requirements traceability matrices, IQ/OQ/PQ protocols, risk assessments, and validation summary reports. - Ability to perform software release impact assessments and translate technical changes into validation requirements. - Excellent technical writing skil…