Validation Associate Consultant

Overview

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide.

ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS.

The Validation Associate Consultant is part of the Testing and QA Expertise Center that adopts the latest cutting-edge technologies, methods, and automation to drive enterprise testing efficiency.

• 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.

• Bachelor’s or Master’s degree in Engineering, Science, Medical, or a related field.
• 3+ 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…