{"id":2109995,"url":"https://alion.io/job/elevatebio-validation-engineer-i","title":"Validation Engineer I","company":{"id":3157164,"name":"ElevateBio","domain":"elevate.bio","url":"https://alion.io/company/elevate-bio","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":105000,"max":145000,"currency":"USD","period":"year","gross":null,"usd_annual":145000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-08T19:40:59Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-11T21:49:50Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.\nThe Role\nElevateBio is looking to hire a Validation Engineer I to join the Validation Engineering. The Validation Engineer I will perform qualification activities for the manufacturing facility, utilities, equipment, and instruments. The Validation Engineer I will provide validation support for technical transfer, capital projects and ongoing validation improvement projects on site working with Facilities, Capital Projects Engineering, Process Engineering, Manufacturing, Quality Control and Quality Assurance (QA) teams.\nHere’s What You’ll Do\nIndependently perform validation activities including installation qualification, operational qualification, performance qualification for BaseCamp projects related to facility, utilities, equipment and instrument\nGenerate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution\nEnsure deliverables meet the overall facility milestones\nPerform and support periodic assessment review and revalidation activities\nEnsure deliverables are executed per ElevateBio Validation Master Plan and other required SOPs\nEnsure discrepancies are resolved and closed out in a timely manner\nDevelop testing templates and qualification protocols using paper and electronic validation systems (Kneat)\nPerform system impact assessments, risk assessments\nSupport development and review of engineering lifecycle documents for new and existing equipment\nMaintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs\nSupport validation activities related to tech transfer projects for all manufacturing suites\nSupport site capital projects and other improvement projects\nPromote engineering best practices, Elevate SOPs, and cGMP regulations\nWork with Quality Assurance to ensure all validation activities are in compliance\nSupport and execute Change Controls to qualified facilities, equipment, and utilities\nRequirements\nBachelor’s degree in engineering or related field and at least 5 years of experience, OR Master’s degree with at least 3 years of related experience, OR PhD with at least 1 year of experience.Experience in cGMP facility/equipment start-up, commissioning, and qualification\nExperience in cGMP processes such upstream cell expansion, downstream purification, and fill finish. Viral vector & Cell/Gene Therapies experience is a plus\nExperience in using Kneat is a plus\n\nStrong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GxP laboratories\nRequired experience with good documentation practices and cGMP standards\nAbility to work on multiple tasks simultaneously\nAbility to manage priorities, deliverables, and schedule milestones\nStrong interpersonal, verbal communication, and technical writing skills\nPhysical and Environment Requirements:\nAbility to stand, walk, bend and stretch for extended period of time\nAbility to lift 15-20 lbs\nAbility to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.\nAbility to perform routine repetitive motions with use of arms, wrists and hands\nThe budgeted range for this position is$105,000 - $145,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law. \nElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.","description_format":"text","description_chars":4237,"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":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Cell & Gene Therapy"],"lifecycle":[{"event":"open","at":"2026-10-08T21:55:42Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":16,"reasons":["conf:1","win:early","comp:junior"],"computed_at":"2026-10-10T05:45:15Z"},"pay":{"stated_usd_annual":145000,"is_top_pay":true},"html_url":"https://alion.io/job/elevatebio-validation-engineer-i","json_url":"https://alion.io/job/elevatebio-validation-engineer-i.json","meta":{"generated_at":"2026-10-11T22:29:27Z","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":12424,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-12T00:00:00Z"}},"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":3157164},"rest":"https://alion.io/mcp/rest/get_company?id=3157164"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Felevatebio-validation-engineer-i"},{"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%2Felevatebio-validation-engineer-i"},{"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%2Felevatebio-validation-engineer-i"},{"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/elevatebio-validation-engineer-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Felevatebio-validation-engineer-i"}]}