Validation Associate Consultant - Princeton - Zs Associates

Description

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. 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.

What you'll do

• 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.

What you'll bring

• 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 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

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. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.

Perks & Benefits

ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths, and collaborative culture empower you to thrive as an individual and global team member.

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 onsite 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; the 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.

Considering applying?

At ZS, we honor the visible and invisible elements of our identities, personal experiences and belief systems—the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives and experiences. We are committed to building a team that reflects a broad variety of backgrounds, perspectives and experiences. We support inclusion and belonging efforts and networks to assist our ZSers in cultivating community spaces and obtaining resources they need to thrive. If you're eager to grow, contribute and bring your unique self to our work, we encourage you to apply.

ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.

To complete your application

Candidates must possess or be able to obtain work authorization for their intended country of employment. An online application, including a full set of transcripts (official or unofficial), is required to be considered.

NO AGENCY CALLS, PLEASE.

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