{"id":765056,"url":"https://alion.io/job/genezenlabs-validation-engineer-iiiii","title":"Validation Engineer II/III","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":"A","score":92,"open_postings":3,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":46,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","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":105000,"max":130000,"currency":"USD","period":"year","gross":null,"usd_annual":130000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-02T20:30:05Z","employer_posted_date":"2026-09-02","last_verified_at":"2026-10-29T11:26:19Z","board_verified":true,"closed_at":null,"days_open":56,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":56},"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\nGenezen is hiring a Validation Engineer II/III to support validation and manufacturing operations by executing and documenting equipment, utility, facility, and process qualification activities. The role will assist in process transfers, scale-up, and process validation efforts while ensuring compliance with internal procedures, cGMPs and regulatory requirements. Responsibilities include preparing validation protocols and reports, supporting the manufacture of cGMP materials, conducting risk assessments, and developing and maintaining quality system documentation, including SOPs, technical reports, and validation records. The position works cross-functionally to ensure projects are completed on schedule and in accordance with quality and regulatory expectations.\nJOB RESPONSIBILITIES:\nProtocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities\nReview and approve qualification documentation on behalf of the validation department.\nEnsure performance of all qualification activities is in accordance with internal procedures, industry best practices and regulatory guidance.\nSupport investigations in protocol nonconformances, deviations discrepancies, and failures. Support root-cause investigations and development of appropriate CAPAs.\nServe as initiator and owner of validation related change controls and corrective and preventative actions.\nAuthor standard operating procedures related to validation practices.\nReview engineering and technical documentation, including P&IDs, equipment specifications, drawings, manuals, and functional/design specifications.\nSupport commissioning and startup activities and ensure appropriate transition from commissioning to qualification\nSupport the execution and generation of formal risk assessments.\nSupport the generation and implementation of validation programs.\nIdentify opportunities to improve validation processes, reduce execution timelines, and increase operational efficiency while maintaining compliance.\nSupport audits and regulatory inspections, as needed.\nSPECIAL WORK REQUIREMENTS\nFully onsite position\nAdaptability required as work schedule may change based on business needs\nCriminal background check required\nOther duties as assigned\n\nEDUCATION/CERTIFCATIONS/LICENSES\n\nBachelor's degree in Engineering, Biotechnology, Biological Sciences, or a related technical discipline.\n\nEssential\n\nON-THE-JOB EXPERIENCE\n\n5-8 years of validation experience\n\nEssential\n\nExperience working in clean room environments.\n\nEssential\n\nExperience with aseptic fill finish technique.\n\nEssential\n\nExperience with validation lifecycle management and continued process verification.\n\nEssential\n\nKNOWLEDGE, SKILLS AND EXPERIENCE\n\nStrong interpersonal and communication skills, both verbal and written, with demonstrated experience preparing technical documents such as protocols, reports, SOPs, and risk assessments.\n\nEssential\n\nAbility to work collaboratively as part of cross-functional teams maintaining effective communication with project team members to achieve project objectives including effectively reporting project activity in a clear and concise manner.\n\nEssential\n\nProficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Visio, with the ability to develop technical documentation, analyze data, and create process flow diagrams.\n\nEssential\n\nDemonstrated ability to effectively manage competing priorities, adapt to changing business needs, and meet challenging deadlines in a fast-paced environment while maintaining quality, compliance, and adherence to project timelines.\n\nEssential\n\nStrong working knowledge of GxP regulations including 21 CFR Parts 11, 210/211, EU GMP Annex 1 and 11, data integrity guidances, ICH guidelines with the ability to assess compliance risks.\n\nEssential\n\nCOMPENSATION RANGE\nThe anticipated annual salary range for the Validation Engineer II/III position is $105,000-$130,000. Actual annual salary and level will be determined based on relevant experience, skills and education.\nWork Environment\nRegularly sit for long periods of time\nMovement\nFrequently required to stand; sit; 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":8119,"description_truncated":false,"requirements":{"experience_years_min":5,"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":34,"band":"fade","label":"Fading","p_open":1,"p_active":0.626,"p_room":0.55,"age_days":56,"expected_fill_days":46,"reasons":["conf:2","win:tail"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":130000,"is_top_pay":true},"html_url":"https://alion.io/job/genezenlabs-validation-engineer-iiiii","json_url":"https://alion.io/job/genezenlabs-validation-engineer-iiiii.json","meta":{"generated_at":"2026-10-29T12:58:07Z","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":19529,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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-validation-engineer-iiiii"},{"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-validation-engineer-iiiii"},{"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-validation-engineer-iiiii"},{"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-validation-engineer-iiiii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenezenlabs-validation-engineer-iiiii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":765056}},{"tool":"search_jobs","arguments":{"company":"genezen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":765056},"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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