ZS · 16 hours ago
Validation Consultant
Princeton, NJ
Full-time
Hybrid
Senior Level
6+ years expZS is a management consulting and technology firm focused on improving lives through data, science, and technology. The Validation Consultant will act as a trusted advisor on compliance and validation, leading the end-to-end lifecycle for GxP-regulated systems and ensuring that validation strategies align with regulatory expectations.
ConsultingManagement ConsultingMarketing
Responsibilities
Act as a trusted CSV/CSA advisor to client stakeholders, partnering with business, IT, QA, and compliance teams to design and sustain compliant, efficient validation programs
Lead the end-to-end CSV lifecycle for GxP-regulated systems, including strategy definition, planning, execution, and audit readiness
Draft, review, and approve validation deliverables such as Validation Plans, URS, FS, DS, Risk Assessments, IQ/OQ/PQ protocols and reports, Traceability Matrices, Error Logs, Configuration Documents, and Validation Summary Reports, ensuring compliance with 21 CFR Part 11, EU Annex 11, and global regulatory expectations
Define and present validation strategies and POVs for modern technologies, including AI/ML models, GenAI-enabled systems, and R/Python-based analytics, and support their implementation in client environments
Apply and advocate risk-based CSA approaches aligned with GAMP 5 (2nd Edition) to balance compliance, efficiency, and business value
Oversee and coordinate testing and validation activities across unit, system, integration, UAT, performance, and regression testing
Manage validation execution and traceability using tools such as JIRA, HP ALM, Solution Manager, Kneat, or equivalent platforms
Provide SME support on GxP, CSV, CSA, data integrity, and regulatory compliance topics during audits, inspections, and client reviews
Develop, review, and implement CSV SOPs, work instructions, and quality processes, ensuring alignment with global regulatory requirements
Mentor and guide junior validation team members, supporting capability building and consistency across engagements
Deliver training sessions on CSV, quality, and compliance practices to client users and internal teams
Qualification
Required
Bachelor's or Master's degree in Engineering, Science, Medical, or a related field
6+ years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA, EU, MHRA)
Able to travel up to 20%
Strong practical knowledge of global regulations and guidelines, including 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, QSR, ISO 13485, HIPAA, and related standards
Proven experience delivering full validation documentation and qualification activities (IQ/OQ/PQ/UAT) across Agile and traditional SDLC models
Deep understanding of CSV/CSA risk assessments, including GxP, business, and functional risk analysis, system gap assessments, and remediation planning
Strong awareness of evolving industry trends in CSV validation, with the ability to adapt validation strategies for GenAI and AI/ML-based systems
Experience with automation concepts, including test automation frameworks and validation considerations for automated testing
Hands-on exposure to data platforms and ETL validation, including SQL-based validation, data verification, and troubleshooting
Experience working with Pharma/Biotech R&D systems, with a solid understanding of drug development processes from discovery through post-marketing
Excellent client-facing skills, with the ability to articulate validation rationale, risk-based decisions, and compliance strategies to both technical and non-technical stakeholders
Strong command of Good Documentation Practices (GDP) and quality systems implementation
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
Strong verbal and written communication skills, with confidence presenting to clients and leadership
Ability to operate independently while collaborating effectively across global, cross-functional teams
Fluency in English
Client-first mentality
Intense work ethic
Collaborative spirit and problem-solving approach
Benefits
Health and well-being
Financial planning
Annual leave
Personal growth and professional development
Robust skills development programs
Multiple career progression options
Internal mobility paths
Collaborative culture
Company
ZS is a management consulting and technology firm that partners with companies to improve life and how we live it.
10001+ employees
H1B Sponsorship
ZS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (351)
2024 (297)
2023 (251)
2022 (440)
2021 (292)
2020 (164)
Funding
Current Stage
Late StageLeadership Team
Arun Shastri
Principal
Victoria L Summers
Principal
Recent News
2025-12-30
2025-12-11
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