Build our future together:Regeneron is seeking a Process Controls & Validation Engineer to join our Process Sciences Drug Product Engineering department. Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. This non-lab based role focusing on fill finish operations provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer to post-commercial lifecycle management activities.When & where:Location: East Greenbush, New York, United StatesWork model: Monday-Friday, 8am-4:30pm Discover your role:Supports technology transfer, process control strategy, validation, and post-commercialization activitiesEvaluates product and process risks throughout the process lifecycleAnalyzes data from development, characterization, and at-scale manufacturingCollaborates with Manufacturing, QC, QA, and CMC Regulatory to support process lifecycle managementAuthors protocols, reports, and technical documents based on process and product knowledgeEnsures SOPs, policies, and validation plans align with industry and regulatory standards (e.g., ICH guidelines)Supports audits, inspections, and CMC regulatory submissionsApplies engineering principles to develop and execute process controls and validation strategiesUses statistical and engineering methods to assess manufacturing process performanceSupports laboratory and manufacturing-scale studiesThe environment and physical rhythms of the role:Gowning: 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)Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attireThis role requires: BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferredProcess Controls & Validation Engineer: 2+ years of relevant experienceSr. Process Controls & Validation Engineer: 5+ years of relevant experienceLevel is determined based on qualifications relevant to the roleA background in aseptic processing/ fill finish, technology transfer, drug product process development, or biopharmaceutical process validation is preferredDoes 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. Where 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. Please 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.As 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.For jobs in Canada: this posting is for an existing position.Salary Range (annually)$62,355.00 - $110,000.00