{"id":3031583,"url":"https://alion.io/job/american-regent-validation-engineer-i","title":"Validation Engineer I","company":{"id":2011712,"name":"American Regent","domain":"americanregent.com","url":"https://alion.io/company/americanregent","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":78,"open_postings":9,"ghost_share":0,"stale_share":0.889,"repost_share":0,"time_to_fill_p50_days":32,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["New Albany, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":57000,"max_usd":104000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4343},"experience_years_min":1,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Matter","optional":false}],"status":"live","first_seen_at":"2026-10-20T00:00:00Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-11-09T20:12:54Z","board_verified":true,"closed_at":null,"days_open":21,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":21},"description":"Nature and Scope\nThe Validation Engineer I will develop and execute validation protocols and reports that support the business needs of the company. The position will support the qualification and validation of the pharmaceutical manufacturing processes and ensure that the facility, systems and processes perform according to internal specifications, comply with current GMPs and are maintained in a validated state.\nEssential Duties and Responsibilities\nNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\nThe incumbent will act as a Subject Matter Expert (SME) for a designated discipline/s. Focusing on Packaging, Equipment and Facilities and/or Cleaning Validation, the incumbent will develop and execute validation protocols associated with the installation, operation and performance qualification and requalification of equipment, utilities and processes used in the manufacture of aseptically produced parenteral pharmaceuticals, including lyophilized and solutions.\nThe SME will provide technical expertise during design, evaluation and procurement of new equipment, utilities or processes. \nMaintain life cycle documentation for equipment and systems, including User Requirements Specifications, Functional Specifications, Hardware Design Specifications, Software Design Specifications, and Configuration Specifications.\nSupport all aspects of the Validation Life Cycle, from design through operation and improvement.\nPlan and coordinate site-specific validation project activities including protocol development/approval, work schedules and lifecycle documentation.\nReview qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures and accurate data analysis.\nProvide and document training to personnel performing validation activities.\nProvide the technical input to address validation deviations and provide assessments for change requests and identify qualification requirements to ensure compliance to GMP’s and that the validated state is maintained.\nCoordinate protocol approvals and produce accurate summary reports.\nDevelop or contribute to the development of SOPs related to equipment or processes for which the incumbent serves as SME.\nRemain current with FDA guidance’s and requirements regarding the validation of aseptic manufacturing processes; ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.\nProvide technical and troubleshooting assistance for identifying and addressing manufacturing anomalies or deviations. \nInterface with Quality, Manufacturing, Packaging and Engineering groups to facilitate and drive validation execution and completion.\nPerform any other tasks/duties as assigned by management.\nWe all must embrace the QUALITY culture.\nQualifications and Requirements\nBachelor’s Degree in Life Sciences, Engineering or equivalent required.\nMinimum 1 year performing validation activities in Pharmaceutical, Biopharmaceutical or related Life Science industry required.\nKnowledge and understanding of cGMP regulations and practices pertaining to validation principals, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.\nStrong knowledge of MS-Office software and PC Skills required.\nAbility to read/interpret engineering drawings and design documents.\nGood technical writing skills.\nExcellent communication, problem-solving, planning and organization skills\nAbility to work independently with minimum supervision, including making sound decisions and managing priorities that are in alignment with departmental and site directives.\nAbility to work within a team oriented environment.\nAbility to work off hours and weekends.\nTravel for Factory Acceptance Testing may be required on occasion (Physical Environment and Physical Requirements\nPhysically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. \nAmerican Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.\nApplicants have rights under Federal Employment Laws.\nFMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf\n\nKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)\n\nEmployee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf\n\nAlert: We’re aware of individuals impersonating our staff to target job seekers. Please note:\n·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.\n·Our recruiting process includes multiple in person and/or video interviews and assessments.\n·If you are unsure about the legitimacy of a message, contact John Rossini at  before responding.\n·We never request payment, bank information, or personal financial details during our offer process.\nYour security is important to us, and we encourage you to stay vigilant when job searching.\nAmerican Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email .","description_format":"text","description_chars":5839,"description_truncated":false,"requirements":{"experience_years_min":1,"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":["Prescription Drugs","Generic Drugs"],"lifecycle":[{"event":"open","at":"2026-10-21T20:24:51Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 3 · green card filings: 1","filings_12m":3,"filings_prev_12m":3,"green_card_filings_12m":1,"median_offered_wage_usd":112500,"route":null,"cap_exempt":false,"checked_at":"2026-11-09T07:32:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":73,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.813,"p_room":0.9,"age_days":20,"expected_fill_days":32,"reasons":["conf:1","win:mid","comp:junior"],"computed_at":"2026-11-09T06:03:00Z"},"pay":null,"html_url":"https://alion.io/job/american-regent-validation-engineer-i","json_url":"https://alion.io/job/american-regent-validation-engineer-i.json","meta":{"generated_at":"2026-11-10T01:51:28Z","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":4302,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":2011712},"rest":"https://alion.io/mcp/rest/get_company?id=2011712"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famerican-regent-validation-engineer-i"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Famerican-regent-validation-engineer-i"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Famerican-regent-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/american-regent-validation-engineer-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famerican-regent-validation-engineer-i"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3031583}},{"tool":"search_jobs","arguments":{"company":"americanregent.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3031583},"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. Docs: https://alion.io/developers"}}