Business Analyst

Job title Business AnalystLocation Raritan NJEmployment type Full-timeWork Model Hybrid - 3 days onsite per weekSalary Range 95000-125000 annuallyAbout the RoleWe 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 ResponsibilitiesGather 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 reportingrelease.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 patientproduct risk and data integrity.Author andor 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 Qualifications4 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 QualificationsExperience 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 - AdvancedFor 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-USglobant.comApplicant Privacy Globant will collect and process your information as a part of this application should you choose to submit it. For additional information please see Globants Privacy Policy.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.