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.

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 skills with experience producing compliance-focused and inspection-ready documentation.
• Experience supporting validation execution activities, including evidence collection, deviation documentation, and results evaluation.
• Strong communication skills with the ability to collaborate effectively with QA, IT, business users, and client stakeholders.
• Experience working as an embedded consultant or staff augmentation resource within client teams.
• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field; advanced education is a plus.

Preferred qualifications include:

• Hands-on validation experience with ERP, quality management, or manufacturing platforms such as QAD ERP, NetSuite, QAD EQMS, or ETQ.
• Experience validating related solutions including serialization, automation platforms, approval workflows, purchasing solutions, or RF technologies.
• Experience creating validation frameworks for new software offerings or emerging technology platforms.
• Background supporting CSV/CSA programs for pharmaceutical or medical device manufacturers.
• Professional certifications related to quality or validation, such as ASQ CQA or CQE.
• Consulting experience with continuous release validation programs or managed validation service models.

• Competitive compensation package.
• Full-time remote position based in the United States.
• Approximately 10% travel to client sites, primarily within North America.
• Comprehensive medical, dental, and vision benefits.
• Generous paid time off and company-observed holidays.
• 401(k) retirement plan with employer match.
• Professional development opportunities and opportunities to expand technical expertise.
• People-focused culture with opportunities to contribute to a growing consulting organization.