Validation Consultant

About the role

The Validation Consultant in the Testing and QA Expertise Center at ZS is responsible for designing and sustaining compliant validation programs, leading the CSV lifecycle, drafting and reviewing validation deliverables, and overseeing testing and validation activities.

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 (preferred), 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.

Requirements

• Bachelor’s or Master’s degree in Engineering, Science, Medical, or a related field.
• 6 - 10 years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA, EU, MHRA).
• 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.
• Able to operate independently while collaborating effectively across global, cross-functional teams.

Qualifications

• Fluency in English.
• Client-first mentality.
• Intense work ethic.
• Collaborative spirit and problem-solving approach.

Skills

• 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.
• 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.
• Strong awareness of evolving industry trends in CSV validation, with the ability to adapt validation strategies for GenAI and AI/ML-based systems.

Benefits

• Comprehensive total rewards package that supports health and well-being, financial future, time away, and professional development.
• Cross-functional skills development & custom learning pathways.
• Milestone training programs aligned to career progression opportunities.
• Internal mobility paths that empower growth via s-curves, individual contribution and role expansions.

Pay

Competitive compensation and benefits package.

Schedule

Hybrid working model with flexibility to work from home and on-site presence at clients/ZS offices for the majority of the week.