{"id":765055,"url":"https://alion.io/job/genezenlabs-senior-csv-validation-engineer","title":"Senior CSV Validation Engineer","company":{"id":719970,"name":"Genezen","domain":"genezen.com","url":"https://alion.io/company/genezen","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":83,"open_postings":3,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":46,"computed_at":"2026-11-04T06:34:25Z"}},"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":"explicit","locations":["Lexington, United States","Lexington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":115000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-02T20:41:08Z","employer_posted_date":"2026-09-17","last_verified_at":"2026-11-04T07:07:15Z","board_verified":true,"closed_at":null,"days_open":62,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":62},"description":"The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. \nWORKING AT GENEZEN\nMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.\nJOB SUMMARY\nThe incumbent is responsible for leading computerized systems validation projects and supporting the data integrity program. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. 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. Collaborates with cross functional teams, ensuring compliance with regulatory requirements, and drives best-in-class validation practices that support our Quality Management System and operational excellence. \nJOB 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\nReview and approve qualification documentation on behalf of the validation function\nEvaluate, audit, and guide software validation activities to ensure compliance with FDA, EU, ISO, Data Integrity guidances, and internal procedures and standards\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 quality events involving CSV in protocol nonconformances, deviations, investigations, CAPAs, and change controls. Serve as initiator and owner of validation related change controls and corrective and preventative actions\nDevelop, author and improve CSV procedures, templates, standards, and guidance. Monitor industry and regulatory trends and recommend improvements to company practices\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\nIdentify data integrity risks and partner with system owners to implement remediation plans\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\nPromote a strong data integrity culture across GxP functions\nSupport audits and regulatory inspections in representing CSV, as needed\nSPECIAL JOB REQUIREMENTS\nAdaptability required as work schedule may change based on business needs\nCriminal background check required\nOther duties as assigned\nEDUCATION / CERTIFICATIONS / LICENSES\nA minimum of a bachelor’s degree in Engineering, Computer Science or related discipline\nON-THE-JOB EXPERIENCE\n7+ years of Computer System Validation 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\nSKILLS / ABILITIES\nThe ability to communicate effectively with employees of all experience levels from Genezen and other contract firms\nThe ability to report on project activity in a clear and concise manner\nThe ability to communicate and work effectively with fellow project team members\nAbility to work well with diverse groups in a matrix-style, growing, safety focused organization\nUnderstanding of cGMP regulations\nStrong technical writing skills\nStrong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat\nStrong project management skills with the ability to manage 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\nCOMPENSATION RANGE\nThe anticipated annual salary range for the Sr. Validation CSV positions is $115,000-$140,000. \nPHYSICAL DEMANDS \nWhile performing the duties of this job, the employee is required to meet the following physical demands:\nWork Environment\nRegularly sit for long periods of time.\nMovement\nFrequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms\nOccasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl\nLifting\nFrequently lift and/or move up to 10 pounds\nRarely lift and/or move up to 25 pounds\nVision\nFrequently utilize close vision and the ability to adjust focus\nCommunication\nFrequently required to communicate by talking, hearing, using telephone and e-mail\nGENEZEN'S CURESVALUE-BASED COMPETENCIES\nCommitted to Science\nWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.\nUrgency in action for the patients\nWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.\nResilience & Grit in operations\nWe are committed to overcoming challenges, learning from failures, and persistently striving for success. \nExecute with Excellence & Integrity\nWe are dedicated to delivering quality results and upholding ethical principals.\nSolutions driven for our partners\nWe are committed to being a proactive, collaborative, creative and open-minded partner.\nGENEZEN'S BENEFITS\nPaid vacation days, amount based on tenure\nPaid sick time\n10 observed holidays + 2 floating holiday + 1 volunteer day\n401(k) plan with company match up to 6% of salary\nShare Appreciation Rights\nChoice of several healthcare plans\nFSA and HSA programs\nDental & vision care\nEmployer-paid basic term life/personal accident insurance\nVoluntary disability, universal life/personal accident insurance\nAccidental Death & Dismemberment (AD&D) Insurance\nADDITIONAL DETAILS\nNothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\nThis position requires a criminal background check.\nGenezen is an Equal Opportunity Employer.\nGenezen participates in EVerify.\nGenezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.\nGenezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. \nFishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.\nLexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.","description_format":"text","description_chars":8457,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-09-11T19:41:46Z"}],"visa":[],"liveness":{"score":31,"band":"fade","label":"Fading","p_open":1,"p_active":0.709,"p_room":0.44,"age_days":62,"expected_fill_days":46,"reasons":["conf:4","win:tail","crowd:"],"computed_at":"2026-11-04T06:34:25Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":false},"html_url":"https://alion.io/job/genezenlabs-senior-csv-validation-engineer","json_url":"https://alion.io/job/genezenlabs-senior-csv-validation-engineer.json","meta":{"generated_at":"2026-11-04T10:49:40Z","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":16121,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":719970},"rest":"https://alion.io/mcp/rest/get_company?id=719970"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenezenlabs-senior-csv-validation-engineer"},{"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%2Fgenezenlabs-senior-csv-validation-engineer"},{"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%2Fgenezenlabs-senior-csv-validation-engineer"},{"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/genezenlabs-senior-csv-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenezenlabs-senior-csv-validation-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":765055}},{"tool":"search_jobs","arguments":{"company":"genezen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":765055},"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. 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