{"id":2450653,"url":"https://alion.io/job/legend-biotech-it-validation-specialist","title":"IT Validation Specialist","company":{"id":12179,"name":"Legend Biotech","domain":"legendbiotech.com","url":"https://alion.io/company/legend-biotech","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Support","role_family":"Support","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Somerset, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":68045,"max":89308,"currency":"USD","period":"year","gross":null,"usd_annual":89308},"salary_estimate":null,"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-27T20:20:12Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-13T22:28:13Z","board_verified":true,"closed_at":null,"days_open":47,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":47},"description":"Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.\nLegend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.\nLegend Biotech is seeking anIT Validation Analyst as part of the R&D Systems team based in Somerset, NJ. \nRole Overview\nThe IT Validation Analyst is responsible for supporting and executing validation activities for GxP-regulated computerized systems. This role ensures systems are implemented, maintained, and operated in compliance with regulatory requirements and company procedures. The analyst works closely with IT, Quality Assurance, Business Process Owners, and vendors to ensure validated systems remain compliant throughout their lifecycle.\nKey Responsibilities\nExecute and support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities for GxP-regulated systems.\nAuthor and maintain validation documentation, including:Validation Plans\nUser Requirements Specifications (URS)\nRisk Assessments\nTest Scripts (IQ/OQ/UAT)\nTraceability Matrices\nValidation Summary Reports\n\nPerform risk-based assessments to determine validation scope, testing requirements, and compliance impact.\nCoordinate and execute validation testing activities, document results, and ensure timely resolution of testing issues and deviations.\nMaintain and manage validation documentation and test execution activities using VLMS, EDMS, and QMS systems. Experience with ValGenesis and Veeva Quality Vault preferred.\nSupport Change Controls, Deviations, CAPAs, and Periodic Reviews of GxP computerized systems to ensure systems remain in a validated state.\nEnsure compliance with applicable regulations, standards, and guidance.\nAssist during internal and regulatory audits by providing validation documentation and support.\nProvide guidance to system owners and project teams regarding validation requirements and best practices.\nRequirements\nBachelor’s Degree in a Life Science, IT, Engineering or a related field\n1-3 years of hands-on experience in Computer System Validation (CSV) within the biotech or pharmaceutical industries, experience with Computer Software Assurance (CSA) and AI a plus.\nKnowledge of Systems and Processes supporting: Quality, IT, Learning Management, Laboratory, Facilities, Equipment, and/or Manufacturing.\nExperience utilizing an automated Validation Lifecycle Management System (VLMS) for executing and managing periodic activities, validation deliverables, and testing activities.\nDemonstrated experience executing validation projects, creating and maintaining deliverables.\nValidation of AI and/or use of AI in validation activities in a GxP environment a plus. \nKnowledge and understanding of GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity requirements) and their impact on CSV/CSA\nExperience in applying risk-based methodologies for CSV/CSA\nExperience in authoring validation deliverables (plans, specifications, test scripts, reports) and corresponding procedures\nFamiliarity with use of electronic systems for Quality Management (QMS), Validation Lifecycle Management (VLMS), and Document Management (EDMS).\nStrong interpersonal, oral and written communication skills.\n AI Literacy: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.\nThe base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.\nOther Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.\nBenefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.\nPay Range (Base Pay):\n$68,045—$89,308 USD\nPlease note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.\nWork Authorization & Employment Eligibility\nApplicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.\nEEO Statement\nIt is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.\nEmployment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.\nFor information related to our privacy notice, please review: Legend Biotech Privacy Notice.","description_format":"text","description_chars":7267,"description_truncated":false,"requirements":{"experience_years_min":1,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Parental leave","Retirement plans","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-13T14:41:34Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 26 · green card filings: 3","filings_12m":26,"filings_prev_12m":27,"green_card_filings_12m":3,"median_offered_wage_usd":116466,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":45,"band":"ok","label":"Likely open","p_open":1,"p_active":0.742,"p_room":0.6,"age_days":47,"expected_fill_days":57,"reasons":["conf:2","win:late","crowd:junior"],"computed_at":"2026-10-14T00:49:53Z"},"pay":{"stated_usd_annual":89308,"is_top_pay":true},"html_url":"https://alion.io/job/legend-biotech-it-validation-specialist","json_url":"https://alion.io/job/legend-biotech-it-validation-specialist.json","meta":{"generated_at":"2026-10-14T00:49:53Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":1165,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":12179},"rest":"https://alion.io/mcp/rest/get_company?id=12179"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flegend-biotech-it-validation-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Flegend-biotech-it-validation-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Flegend-biotech-it-validation-specialist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/legend-biotech-it-validation-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flegend-biotech-it-validation-specialist"}]}