Business Analyst

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.

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