{"id":2803840,"url":"https://alion.io/job/regeneron-change-control-specialist","title":"Change Control Specialist","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":79,"open_postings":26,"ghost_share":0,"stale_share":0.846,"repost_share":0,"time_to_fill_p50_days":28,"computed_at":"2026-10-31T05:58:55Z"}},"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":["Rensselaer, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":62355,"max":128700,"currency":"USD","period":"year","gross":null,"usd_annual":128700},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-07-20T00:00:00Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-10-31T06:57:23Z","board_verified":true,"closed_at":null,"days_open":103,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":103},"description":"Build our future together:\nAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill multiple Change Control Specialist positions. These positions develop strategic plans related to change control and the implementation of robust corrective actions to support manufacturing operations by applying function expertise.\nCurrent Departments with Openings:\nBulk Drug Substance Manufacturing\nTechnical Operations\nFill/Finish Manufacturing\nWhen & where:\nLocation: Rensselaer, New York, United States\nWork model: Monday-Friday, 8am-4:30pm\nDiscover your role:\nCraft business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPA’s) and process improvements in support of manufacturing operations\nAssess sophisticated proposed change controls to evaluate if proposal satisfies company standards\nCoordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change\nReview, edit, and revise controlled documentation in accordance with cGMP standards\nCoordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation\nProvide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls\nIndependently monitor and progress multiple projects concurrently - identifying, addressing, and/or raising potential obstacles in a timely manner\nPresent business critical and regulatory impactful change controls to senior leadership\nDocument all training\nAssist with the training of new employees\nThis role requires:\nBS/BA in Life Sciences, Engineering, or related field; or equivalent combination of education and experience, and the following amount of experience for each level:Associate Change Control Specialist: 0-2+ years of relevant experience\nChange Control Specialist: 2+ years of relevant experience\nSenior Change Control Specialist: 5+ years of relevant experience\nLevel will be determined based on experience\n\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$62,355.00 - $128,700.00","description_format":"text","description_chars":4821,"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":["Annual bonuses","Equity","Wellness"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Oncology Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-18T03:53:48Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 316 · green card filings: 4","filings_12m":316,"filings_prev_12m":157,"green_card_filings_12m":4,"median_offered_wage_usd":151938,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+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":10,"band":"cold","label":"Long shot","p_open":1,"p_active":0.36,"p_room":0.28,"age_days":103,"expected_fill_days":28,"reasons":["conf:3","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":{"stated_usd_annual":128700,"is_top_pay":false},"html_url":"https://alion.io/job/regeneron-change-control-specialist","json_url":"https://alion.io/job/regeneron-change-control-specialist.json","meta":{"generated_at":"2026-10-31T15:02:13Z","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":23407,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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-change-control-specialist"},{"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-change-control-specialist"},{"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-change-control-specialist"},{"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-change-control-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fregeneron-change-control-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2803840}},{"tool":"search_jobs","arguments":{"company":"regeneron.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2803840},"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. 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