Validation Associate Consultant

About the role

The Validation Associate Consultant is part of the Testing and QA Expertise Center at ZS, a management consulting and technology firm focused on improving life and how we live it. This role leverages the latest cutting-edge technologies, methods, and automation to drive enterprise testing efficiency.

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.
• 3+ years of hands-on experience in Computer System Validation within GxP-regulated environments (GCP/GMP; FDA, EU, MHRA).
• 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.
• Able to operate independently while collaborating effectively across global, cross-functional teams.
• Fluency in English.

Qualifications

• 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.
• 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.
• Fluency in English.

Benefits

• Comprehensive total rewards package that supports your 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.
• A hybrid working model: ZS is committed to a Flexible and Connected way of working. ZSers are onsite at clients or ZS offices three days a week. Combined flexibility to work remotely two days a week is also available.

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Full-time position with flexible working hours and remote work options.