The
Validation 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.
What you'll do: Validation Consultant in the Testing and QA Expertise Center will...
- 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.
What You'll Bring - 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).
- 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
How you'll grow:- 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
Perks & Benefits:At ZS, your growth matters. We offer a comprehensive total rewards package that supports your health and well-being, financial future, time away, and professional development. With robust skills-building programs, multiple career progression paths, internal mobility, and a deeply collaborative culture, you'll have the opportunity to do meaningful work, expand your capabilities, and thrive as part of a global community. For details on total rewards in United States, visit ZS US office locations | Where we work | ZS.
Hybrid working model:We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Travel:Travel is a requirement at ZS for client facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures.
