{"id":1644154,"url":"https://alion.io/job/precigen-lead-validation-engineer","title":"Lead Validation Engineer","company":{"id":3188444,"name":"Precigen","domain":"precigen.com","url":"https://alion.io/company/precigen","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Germantown, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":130000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-28T20:37:00Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-13T16:34:20Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"description":"We are seeking a Lead Validation Engineer at our Germantown, MD location to join us in our mission to serve patients through innovative Gene Therapies. This position serves as a technical leader within the Validation function and provides validation engineering support for Precigen's GMP Manufacturing, Quality Control (QC), Facilities, and Research & Development (R&D) operations.\nThe ideal candidate will possess advanced expertise in equipment, utility, facility, and process qualification within regulated GMP environments. This individual will lead complex validation projects, develop validation strategies, provide technical guidance to cross-functional teams, and ensure compliance with applicable regulatory requirements. The successful candidate will be highly organized, technically proficient, detail-oriented, and capable of independently managing multiple high-priority initiatives while driving continuous improvement across the site validation program.\nDuties and Responsibilities\nProvide technical leadership for site validation and qualification activities supporting GMP manufacturing, laboratory, utility, and facility systems.\nLead complex qualification and validation projects from concept through implementation, including new equipment installations, facility expansions, process improvements, utility modifications, and major change control initiatives.\nServe as a Validation Subject Matter Expert (SME) for GMP facilities, utilities, process equipment, analytical instruments, and qualification lifecycle management.\nCoordinate with Facilities, Metrology, Manufacturing, Quality, R&D personnel, contractors, and equipment vendors to maintain validated systems and ensure compliance with regulatory requirements.\nOversee qualification activities for facility systems including HVAC, backup power systems, water purification systems, compressed gas distribution systems, clean utility systems, autoclaves, glass washers, part washers, controlled temperature units, refrigerators, and freezers.\nProvide qualification support for process and analytical equipment including incubators, biosafety cabinets, centrifuges, chromatography systems, filtration systems, PCR systems, environmental monitoring equipment, and laboratory instrumentation.\nDevelop validation strategies and qualification approaches using risk-based methodologies consistent with FDA, EU GMP, ISPE, ASTM, and GAMP principles.\nAuthor, review, approve, and execute Validation Master Plans, Validation Plans, Risk Assessments, Commissioning and Qualification Plans, Protocols, Reports, SOPs, and Work Instructions.\nLead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for facilities, utilities, equipment, and systems.\nPerform and lead Environmental Monitoring Performance Qualification (EMPQ), cleanroom qualification activities, airflow visualization (smoke studies), HVAC performance testing, and autoclave qualification/requalification programs.\nExecute and review controlled temperature unit (CTU) and autoclave temperature mapping studies utilizing Kaye Validators or equivalent data acquisition systems.\nDevelop and facilitate risk assessments including impact assessments, failure mode and effects analyses (FMEA), and other risk-based validation methodologies.\nCollect, evaluate, trend, and interpret validation data to ensure systems remain in a qualified state and are suitable for GMP use.\nProvide technical oversight and review of qualification packages generated by internal personnel, contractors, consultants, and equipment vendors.\nSupport the site Quality Management System (QMS) through authoring, investigation, and review of qualification-related deviations, change controls, corrective and preventive actions (CAPA), and periodic reviews.\nSupport regulatory inspections, client audits, and internal audits as the Validation SME.\nProvide hands-on troubleshooting support and collaborate with original equipment manufacturers (OEMs) and service providers to resolve complex technical issues.\nIdentify and implement continuous improvement opportunities that enhance compliance, efficiency, and effectiveness of validation programs.\nEducation and Experience\nBachelor's degree in Engineering, Life Sciences, Biotechnology, or a related scientific discipline required.\nMinimum of five (5) years of GMP validation and qualification experience within the pharmaceutical, biotechnology, medical device, cell therapy, gene therapy, or related regulated industry.\nDemonstrated experience independently leading complex validation projects and coordinating cross-functional teams.\nExtensive experience with equipment, utility, facility, and process qualification programs within GMP environments.\nProven experience performing and leading: Autoclave Qualification and Requalification\nEnvironmental Monitoring Performance Qualification (EMPQ)\nAirflow Visualization (Smoke Studies)\nControlled Temperature Unit (CTU) Qualification and Temperature Mapping\nUtility Qualification (Compressed Gas, Water, and Clean Utility Systems)\nEquipment IQ/OQ/PQ Activities\n\nExperience authoring and reviewing Validation Master Plans, Validation Protocols, Validation Reports, Risk Assessments, SOPs, and Work Instructions.\nExperience supporting investigations, change controls, deviations, CAPAs, and periodic reviews within a GMP Quality Management System.\nStrong understanding of FDA regulations, EU GMP requirements, Annex 1, Data Integrity principles, and industry best practices for qualification and validation.\nExcellent technical writing, problem-solving, organizational, and project management skills.\nStrong computer skills- familiarity with Microsoft Office, Quality Record Management, Computerized Maintenance Management Systems(CMMS), Building Management/Automation Systems (BMS/BAS), Environmental Monitoring System(EMS), Validation Data Management Software, Computer Aided Design (CAD) and the ability to quickly learn new applications\nAbility to sit, stand, and walk regularly to access mechanical areas and aseptically gown into production suite. Able to maneuver equipment and supplies up to 40 pounds\nOccasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs.","description_format":"text","description_chars":6308,"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":["Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-10-01T22:59:14Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2","filings_12m":2,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":77500,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":72,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.805,"p_room":0.9,"age_days":15,"expected_fill_days":38,"reasons":["conf:13","win:mid"],"computed_at":"2026-10-14T06:34:16Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":false},"html_url":"https://alion.io/job/precigen-lead-validation-engineer","json_url":"https://alion.io/job/precigen-lead-validation-engineer.json","meta":{"generated_at":"2026-10-14T11:45:02Z","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":14080,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"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":3188444},"rest":"https://alion.io/mcp/rest/get_company?id=3188444"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fprecigen-lead-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%2Fprecigen-lead-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%2Fprecigen-lead-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/precigen-lead-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fprecigen-lead-validation-engineer"}]}