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Job title: Business Analyst

Location: Raritan, NJ

Employment type: Full-time

Work Model: Hybrid — 3 days onsite per week

Salary Range: 95,000–125,000 annually

About the Role

We are looking for an experienced Business Analyst with advanced Computer System Validation (CSV) experience to support validated systems and compliance initiatives in a regulated environment. This role will partner with business, Quality, IT, and technical stakeholders to gather and document requirements, support validation planning and testing activities, maintain requirements traceability, and ensure validation deliverables meet applicable GxP and data integrity requirements.

Key Responsibilities

• Gather, analyze, and document business and functional requirements for computerized systems.
• Lead and support Computer System Validation activities across the system lifecycle, including risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release.
• Translate business and compliance needs into clear requirements and validation documentation.
• Develop and maintain Requirements Traceability Matrices (RTMs) to ensure complete coverage from requirements through testing and release.
• Apply a risk-based validation approach considering GxP impact, patient/product risk, and data integrity.
• Author and/or review validation documentation, including Compliance Plans, Test Protocols, Risk Assessments, requirements documentation, RTMs, test scripts, test summaries, and compliance reports.
• Collaborate with Quality, Business, IT, Engineering, and other stakeholders to clarify requirements, risks, assumptions, and validation scope.
• Support test planning and execution, including review of test results, deviations, and supporting evidence.
• Track validation deliverables and ensure documentation is complete, accurate, compliant, and ready for system release.
• Support change management and system updates by assessing impacts to requirements, validation documentation, and existing controls.

Required Qualifications

• 4+ years of experience as a Business Analyst, CSV Analyst, Quality Systems Analyst, or similar role in a regulated environment.
• Advanced experience with Computer System Validation (CSV).
• Strong experience gathering and documenting business and functional requirements.
• Experience with requirements traceability and maintaining RTMs.
• Experience supporting validation planning, testing, deviations, and final validation documentation.
• Strong understanding of risk-based validation, GxP principles, and data integrity.
• Strong documentation, analytical, and stakeholder-management skills.
• Ability to collaborate effectively with business, Quality, IT, and technical teams.
• Must be able to work onsite in Raritan, NJ 3 days per week.

Preferred Qualifications

• Experience within pharmaceutical, biotechnology, medical device, life sciences, or another highly regulated industry.
• Experience supporting system implementations, upgrades, or remediation initiatives.
• Familiarity with Agile, Waterfall, or hybrid delivery methodologies.

Core Skill: Computer System Validation (CSV) – Advanced

For additional information regarding benefits, please see the Globant Experience Guide. 

Accommodations: If you have a need that requires an accommodation, please let us know by contacting the recruiting team at People-US@globant.com

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Equal Employment Opportunity:  Globant is proud to be an equal opportunity and affirmative action employer. We are committed to building a workforce that is representative of the users we serve, creating a culture of belonging, and providing an equal employment opportunity regardless of any basis protected by law.  For Canadian job postings, Globant does not discriminate based on any Canadian Federal or Provincial anti-discrimination law, and offers the same opportunities to all applicants regardless of characteristics. 

Use of AI: Globant may use AI and machine learning technologies in our recruitment process. Globant is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, or any other characteristic protected by applicable federal, state, or local law. Globant is also committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or an accommodation due to a disability, please let your recruiter know.

Remote work:  Remote work permissibility is subject to change depending on business necessity.  For additional questions regarding work locations please discuss with your hiring partner directly.