{"id":2758288,"url":"https://alion.io/job/regeneron-manager-quality-assurance-validation","title":"Manager Quality Assurance Validation","company":{"id":4267,"name":"Regeneron Pharmaceuticals","domain":"regeneron.com","url":"https://alion.io/company/regeneron","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":15,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":32,"computed_at":"2026-10-24T06:02:35Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Saratoga Springs, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":92200,"max":176000,"currency":"USD","period":"year","gross":null,"usd_annual":176000},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"GMP","optional":false},{"name":"HPLC","optional":false},{"name":"Sterilization Validation","optional":false}],"status":"live","first_seen_at":"2026-10-16T00:00:00Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-24T10:27:53Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"Build our future together:\nAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re hiring a Manager Quality Assurance (QA) Validation to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs. This position leads the laboratory and analytical equipment validation function. They are responsible for qualification of laboratory and analytical instrumentation supporting quality control (QC) and manufacturing science functions, with secondary oversight of manufacturing equipment, utility qualification, and cleaning/sterilization validation processes. They will participate in and defend validation data during FDA and other regulatory inspections.\nWhen & where:\nLocation:Initial: Rensselaer, New York, United States\nPermanent: Saratoga Springs, New York, United States\n\nWork model: Monday-Friday, 8am-4:30pmOther requirements: Occasional flexibility may be requested for on-call schedule/weekend work\n\nDiscover your role:\nDesigns and develops policies related to laboratory and analytical equipment qualification and validation, and secondarily to manufacturing equipment, utility, and process validation, ensuring effective administration and regulatory compliance\nResponsible for all aspects of QA laboratory equipment validation, including review and approval of failure investigations, change controls and associated test plan documentation, SOPs, qualification protocols and summary reports, and relevant Validation Master Plan content\nLeads qualification strategy for laboratory and analytical instrumentation (e.g., HPLC, GC, spectrophotometers, balances, incubators, and software-integrated analytical systems) supporting QC, manufacturing science, and release testing\nProvides secondary oversight of manufacturing equipment and utility qualification and cleaning/sterilization validation programs\nDevelops and manages validation budget, contracts, and schedules\n Presents and defends validation data to FDA and other regulatory agencies\nMaintains the validation document and software control system for laboratory equipment and instrumentation qualification records\nEnsures validated state is maintained for laboratory, analytical, and manufacturing equipment used in commercial and clinical operations\nOrganizes QA Validation resources assigned to functional areas to meet goals and timelines; coordinates prioritization of activities with laboratory and manufacturing area management\nPartners with the Director, QA Validation & Computer Systems Assurance, and with Quality Control/Manufacturing Science leadership to align laboratory equipment qualification strategy with the site's CSA and automation qualification programs\nPlays a proactive role in developing and applying new approaches and processes to laboratory and equipment validation strategies for a highly automated facility\nCounsels employees on work performance; conducts hiring and separation activities\nThe environment and physical rhythms of the role:\nGowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)\nAbility to remove jewelry, make-up and nail adornments when wearing cleanroom attire\nAbility to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment\nSome physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs\nThis role requires:\nBS/BA in Engineering, Chemistry, Life Sciences or a related field; or equivalent combination of education and experienceAssociate Manager QA Validation: 6+ years of experience\nManager QA Validation 7+ years of experience\nLevel will be determined based on experience\n\nPrevious people leadership/ supervisory experience\nExperience qualifying laboratory and analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP QC or manufacturing science environment\nExperience validating equipment and utilities in a highly automated or greenfield manufacturing environment is preferred\nDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.\nWhere necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.\nPlease be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.\nAs part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.\nFor jobs in Canada: this posting is for an existing position.\nSalary Range (annually)\n$92,200.00 - $176,000.00","description_format":"text","description_chars":7038,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Annual bonuses","Equity","Wellness"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-17T02:14:04Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":8,"expected_fill_days":32,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":176000,"is_top_pay":true},"html_url":"https://alion.io/job/regeneron-manager-quality-assurance-validation","json_url":"https://alion.io/job/regeneron-manager-quality-assurance-validation.json","meta":{"generated_at":"2026-10-24T23:29:58Z","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":34553,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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":4267},"rest":"https://alion.io/mcp/rest/get_company?id=4267"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fregeneron-manager-quality-assurance-validation"},{"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%2Fregeneron-manager-quality-assurance-validation"},{"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%2Fregeneron-manager-quality-assurance-validation"},{"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/regeneron-manager-quality-assurance-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fregeneron-manager-quality-assurance-validation"}]}