Company OverviewAt Bridgenext , we engineer Growth Operating Systems.
Most enterprises have spent millions on their revenue stack and still aren't seeing the growth they expected.They have tools that function, but no system that wins.
We help growth-hungry companies close that gap by turning fragmented platforms, siloed teams, and disconnected data into one integrated Growth OS.
More than a technology company or marketing agency, we're a integral digital consultancy with experts in engineering, data, AI, creative and more.
Our teams are made up of experts who believe in engineering impact, starting with putting people at the center of everything we do.
Every team member directly shapes our work, culture, and values.
Nothing matters more to us than a kind, respectful, fulfilling environment that supports everyone.
Our flexible, inclusive culture gives you the autonomy, resources, and opportunities to thrive.Position DescriptionWe are seeking an experienced CSV Validation Engineer to support validation, compliance, and quality management activities in a GxP-regulated environment.
Key deliverables are preparation of relevant documentation (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices) to meet regulatory requirements for new and existing products.
You will collaborate with cross functional teams, ensuring compliance with regulatory requirements,



and drives best-in-class validation practices that support our applications and operational excellence.Key ResponsibilitiesLead risk-based validation strategies for GxP computerized systems throughout the system lifecycle including protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GxP software applicationsAssess the impact of system-related events on the system's validated state and data reliabilityLead validation execution and ensure testing is appropriately documentedSupport change control, system upgrades, migrations, releases, and impact assessmentsSupport the execution and generation of formal risk assessmentsSupport and conduct periodic reviewsSupport the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archivalSupport risk-based Data Integrity Assessments and the audit trail review processProvide CSV and Data Integrity expertise during vendor selection and qualification.
Define expectations for vendor testing, validation documentation, audit trails, electronic signatures, and data retentionProvide guidance to project teams, system owners, IT, and vendors regarding GxP validation requirementsHands-on experience with Jira for test management, defect tracking, requirements traceability, and project coordinationCollaborate with business, quality, IT,



and regulatory stakeholders to ensure ongoing compliance with applicable requirementsWorkplaceRemote based role in LATAM, preferably in ArgentinaMust Have SkillsBachelor's degree in computer science, Information Technology, or a related field (or equivalent experience)5+ years of Computer System Validation (CSV) experienceStrong understanding of GxP computerized systems and validation principles with experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality SystemsDemonstrated experience developing and executing risk-based CSV strategiesExperience with computerized system periodic reviewsExperience with audit trail and data integrity assessmentsAbility to report on project activity in a clear and concise mannerAbility to work well with diverse groups in a matrix-style, growing, safety focused organizationStrong technical writing skillsStrong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe AcrobatStrong project management skills with the ability manage multiple activities with challenging timelinesStrong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelinesProfessional SkillsExcellent English communication (written and oral)Excellent analytical and problem-solving skillsAbility to work effectively in a fast-paced, dynamic environmentStrong interpersonal skillsAbility to understand scope and ask the right questionsOrganized, detail and process orientedProven ability to build, manage and foster a team-oriented environmentBridgenext is an Equal Opportunity Employer
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📌 Senior Computer System Validation (Csv) Engineer (Rosario)
🏢 Bridgenext
📍 Rosario