{"id":1724342,"url":"https://alion.io/job/cdmo-drug-device-combination-kindeva-validation-engineer-i","title":"Validation Engineer I","company":{"id":2177732,"name":"Kindeva Drug Delivery","domain":"kindevadd.com","url":"https://alion.io/company/kindevadd","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Dayforce","truth_index":{"grade":"A","score":92,"open_postings":15,"ghost_share":0,"stale_share":0.333,"repost_share":0,"time_to_fill_p50_days":49,"computed_at":"2026-10-15T05:46:00Z"}},"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":["Lexington, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":56000,"max_usd":101000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":3735},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-23T05:00:00Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-15T11:20:49Z","board_verified":true,"closed_at":null,"days_open":22,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":22},"description":"Our Work Matters\nAt Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.\n\nThe Impact You Will Make\nAs a Validation Engineer, you will play a critical role in ensuring our pharmaceutical manufacturing systems and processes meet rigorous regulatory and quality standards. You will lead and execute validation activities—including equipment, utilities, facilities, and process validations—to ensure our operations remain compliant and inspection-ready. Your expertise in cGMP, risk-based validation, and technical writing will directly impact the safety, efficacy, and consistency of the drug products we deliver. This is a highly visible, hands-on role ideal for a detail-oriented professional passionate about quality and continuous improvement in a dynamic, fast-paced environment\n\nResponsibilities:\nValidation Strategy & Execution\nDevelop, execute, and maintain validation protocols and reports (IQ, OQ, PQ) for equipment, utilities, and manufacturing processes.\nSupport commissioning and qualification (C&Q) activities for new equipment and facilities, ensuring compliance with FDA, EU, and global regulatory expectations.\nAuthor and review validation lifecycle documentation, including plans, protocols, deviations, and final reports.\nPartner with Engineering, Manufacturing, Quality, and Regulatory Affairs to ensure effective cross-functional validation planning and execution.\nPerform periodic reviews and revalidation activities in accordance with lifecycle requirements.\nCompliance & Risk Management\nLead risk assessments (FMEA, gap assessments) to determine validation strategy and appropriate testing requirements.\nProvide validation input during change control, deviation investigations, and CAPA execution.\nEnsure data integrity and good documentation practices in all validation records.\nAct as subject matter expert (SME) during internal and external audits and inspections.\nContinuous Improvement\nEvaluate validation program effectiveness and recommend process improvements to enhance compliance, efficiency, and scalability.\nStay current with industry best practices and evolving regulatory guidance to ensure validation activities remain aligned with expectations.\n\nQualifications:\nBachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience with a strong maintenance/engineering background or GxP.\nStrong maintenance/engineering background or GxP\nExperience in developing and executing validation documentation (IQ/OQ/PQ, protocols, reports).\nStrong organizational, communication, and technical writing skills.\nAbility to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment.\n\nPreferred Qualifications:\nFamiliarity with validation of automated systems and computerized system validation (CSV).\nDemonstrated knowledge of FDA, EU, and ICH regulatory requirements including 21 CFR Part 11 and Annex 15.\nExperience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom validation.\nWorking knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva).\nLean Six Sigma or other continuous improvement training/certifications.\n\n#LI-Onsite","description_format":"text","description_chars":3275,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Ammunition","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-02T21:39:44Z"}],"visa":[],"liveness":{"score":70,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.776,"p_room":0.9,"age_days":22,"expected_fill_days":49,"reasons":["conf:2","win:mid","comp:junior"],"computed_at":"2026-10-15T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/cdmo-drug-device-combination-kindeva-validation-engineer-i","json_url":"https://alion.io/job/cdmo-drug-device-combination-kindeva-validation-engineer-i.json","meta":{"generated_at":"2026-10-15T14:31:37Z","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":22233,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"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":2177732},"rest":"https://alion.io/mcp/rest/get_company?id=2177732"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcdmo-drug-device-combination-kindeva-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%2Fcdmo-drug-device-combination-kindeva-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%2Fcdmo-drug-device-combination-kindeva-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/cdmo-drug-device-combination-kindeva-validation-engineer-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcdmo-drug-device-combination-kindeva-validation-engineer-i"}]}