{"id":2753399,"url":"https://alion.io/job/iovance-biotherapeutics-computer-systems-validation-analyst-ii","title":"Computer Systems Validation Analyst II","company":{"id":449873,"name":"Iovance Biotherapeutics","domain":"iovance.com","url":"https://alion.io/company/iovance-biotherapeutics","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":92,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":48,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Analytics","role_family":"Analytics","seniority":"middle","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":120000,"max":135000,"currency":"USD","period":"year","gross":null,"usd_annual":135000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"Agile","optional":false},{"name":"Waterfall","optional":false}],"status":"closed","first_seen_at":"2026-10-16T22:34:56Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-30T22:56:16Z","board_verified":false,"closed_at":"2026-10-30T22:56:16Z","days_open":14,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":14},"description":"AboutIovance Biotherapeutics, Inc. \nIovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com. \nAmtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. \nInformation on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com. \nOverview\nThe Computer Systems Validation Analyst II supports all aspects of the Computer Systems Validation (CSV) Lifecycle. This employee will create documentation, execute implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies. They should be able to work either independently or as part of a team to deliver computer system validation projects on time and within budget. They must have experience generating CSV lifecycle documentation to meet ongoing requirements such as 21CFR Part 11, EU Annex 11, and data integrity.\nEssential Functions and Responsibilities\nExpertise with 21 CFR Part 11, Annex 11, GAMP 5, and data integrity ALCOA+.\nComplete the execution and documentation required per the CSV. This includes all CSV activities, documentation requirements and reports including plans, risk assessments, user requirements, functional requirements, specifications, data integrity assessments, testing, change controls, traceability matrix, qualification protocols,validation and compliance reviews. Scope includes direct impact laboratory, manufacturing and enterprise (multi-site) applications.\nExperience with Agile, Waterfall, and hybrid SDLC models for regulated systems.\nEnsure project deadlines and performance standards are met while responding to inquiries from management, end users and clients and providing status updates on a frequent basis.\nWork collaboratively to ensure and support the timely delivery of validated computer systems for internal clients.\nImplement action items as assigned for change controls.\nManage periodic reviews of computerized systems and data integrity/data quality\nMust adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.\nPerform ad-hoc duties as assigned. \nRequired Education, Skills, and Knowledge\nDegree in Information Technology, Life Science or Technical discipline.\n5+ years of relevant industry experience.\nDemonstrated project management ability with good written and strong communication is required.\nKnowledge of the computerized system lifecycle activities, CSV, and IT controls in a regulated\nDetail-oriented mindset ensuring accuracy and compliance in documentation.\nExperience successfully coordinating and navigating complex issues with internal and external\nDetail oriented and organized, ensuring accuracy at all times.\nSelf starter with the ability to work independently while managing multiple validation activities in a fast-paced environment.\nHighly motivated and proactive, able to anticipate validation needs and drive tasks to completion with minimal supervision. \nThe physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.\nPhysical Demands and Activities Required\nMust be able to remain in a stationary position standing or sitting for prolonged periods of time.\nMust be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.\nMust have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.\nThis position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.\nMust be able to communicate with others to exchange information. \nMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines \nWork Environment \nThis job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.\nThe annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills. \nPay Transparency\n$120,000—$135,000 USD\nThe statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.\nIovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact . \nBy voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.","description_format":"text","description_chars":7053,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T17:56:14Z"},{"event":"close","at":"2026-10-30T22:56:16Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 3 · green card filings: 2","filings_12m":3,"filings_prev_12m":12,"green_card_filings_12m":2,"median_offered_wage_usd":183500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+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":null,"pay":{"stated_usd_annual":135000,"is_top_pay":true},"html_url":"https://alion.io/job/iovance-biotherapeutics-computer-systems-validation-analyst-ii","json_url":"https://alion.io/job/iovance-biotherapeutics-computer-systems-validation-analyst-ii.json","meta":{"generated_at":"2026-10-31T13:50:46Z","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":21446,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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":449873},"rest":"https://alion.io/mcp/rest/get_company?id=449873"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fiovance-biotherapeutics-computer-systems-validation-analyst-ii"},{"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%2Fiovance-biotherapeutics-computer-systems-validation-analyst-ii"},{"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%2Fiovance-biotherapeutics-computer-systems-validation-analyst-ii"},{"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/iovance-biotherapeutics-computer-systems-validation-analyst-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fiovance-biotherapeutics-computer-systems-validation-analyst-ii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2753399}},{"tool":"search_jobs","arguments":{"company":"iovance.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2753399},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}