{"id":1264772,"url":"https://alion.io/job/bridgenext-senior-computer-system-validation-csv-engineer","title":"Senior Computer System Validation (CSV) Engineer","company":{"id":2442558,"name":"Bridgenext","domain":"bridgenext.com","url":"https://alion.io/company/bridgenext","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Argentina"],"countries":["AR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":39000,"max_usd":88000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":3947},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Jira","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-25T22:01:31Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-09-29T16:34:21Z","board_verified":false,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Company Overview\nAt 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 global digital consultancy with experts in engineering, data, AI, creative and more.\nOur 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.\nPosition Description\nWe 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.\nKey Responsibilities:\nLead 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 applications\nAssess the impact of system-related events on the system’s validated state and data reliability\nLead validation execution and ensure testing is appropriately documented\nSupport change control, system upgrades, migrations, releases, and impact assessments\nSupport the execution and generation of formal risk assessments\nSupport and conduct periodic reviews\nSupport the evaluation of data lifecycles and data flow from creation through processing, review, approval, reporting, retention, and archival\nSupport risk-based Data Integrity Assessments and the audit trail review process\nProvide CSV and Data Integrity expertise during vendor selection and qualification. Define expectations for vendor testing, validation documentation, audit trails, electronic signatures, and data retention\nProvide guidance to project teams, system owners, IT, and vendors regarding GxP validation requirements\nHands-on experience with Jira for test management, defect tracking, requirements traceability, and project coordination\nCollaborate with business, quality, IT, and regulatory stakeholders to ensure ongoing compliance with applicable requirements\nWorkplace: Remote based role in LATAM, preferably in Argentina\nMust Have Skills:\nBachelor’s degree in computer science, Information Technology, or a related field (or equivalent experience)\n5+ years of Computer System Validation (CSV) experience\nStrong understanding of GxP computerized systems and validation principles with experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems\nDemonstrated experience developing and executing risk-based CSV strategies\nExperience with computerized system periodic reviews\nExperience with audit trail and data integrity assessments\nAbility to report on project activity in a clear and concise manner\nAbility to work well with diverse groups in a matrix-style, growing, safety focused organization\nStrong technical writing skills\nStrong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat\nStrong project management skills with the ability tmanage multiple activities with challenging timelines\nStrong working knowledge of 21 CFR Part 11, EU GMP Annex 11, ICH guidelines, GAMP 5 and data integrity guidelines\nProfessional Skills:\nExcellent English communication (written and oral) \nExcellent analytical and problem-solving skills\nAbility to work effectively in a fast-paced, dynamic environment\nStrong interpersonal skills\nAbility to understand scope and ask the right questions\nOrganized, detail and process oriented\nProven ability to build, manage and foster a team-oriented environment \nBridgenext is an Equal Opportunity Employer","description_format":"text","description_chars":4500,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["IT Consulting & Digital Transformation","Data Engineering & Migration Services"],"lifecycle":[{"event":"open","at":"2026-09-25T22:01:31Z"}],"liveness":{"score":98,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.976,"p_room":1,"age_days":5,"expected_fill_days":30,"reasons":["conf:37","urgency","velocity","win:early"],"computed_at":"2026-10-01T05:45:00Z"},"pay":null,"html_url":"https://alion.io/job/bridgenext-senior-computer-system-validation-csv-engineer","json_url":"https://alion.io/job/bridgenext-senior-computer-system-validation-csv-engineer.json","meta":{"generated_at":"2026-10-02T00:44:18Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":710,"day_limit":5000,"remaining_today":4290,"minute_limit":60,"resets_at":"2026-10-03T00:00:00Z"}}}