QA Validation Specialist (Fill Finish)

Company: Regeneron Pharmaceuticals, Inc.
Location: East Greenbush
Posted on: January 1, 2026

Job Description:

Our Fill Finish QA Validation team is hiring. As the Senior QA Validation Specialist, you will ensure equipment, systems, and processes meet regulatory standards while adhering to company manufacturing policies and procedures. This role will support our Fill Finish facility in Rensselaer, NY. Equipment Includes: Syringe and Vial Fillers, Lyophilizer, Semi-Automatic and Automatic Inspection, Assembly Machines, Packaging Machines, Serialization, Case Packer and Palletizer In this role, a typical day might include the following: Monitor compliance, analyze failures, and assess corrective actions. Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g. Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control) Must be able to present in a pressure test scenario the technical area they are SME for Stays current with industry trends, regulatory requirement updates, and motivates changes and improvements based on trends. Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria Analyzes the results of testing and determines the acceptability of results against pre-determined criteria. Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. Reviews, edits and approves change controls, SOPs, reports and other documentation Coordinates with other departments or outside contractors/vendors to complete validation tasks. Collaborates with functional departments to resolve issues. Trains/advises less experienced Specialists. May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines. Manage and drives projects and prepares status reports. May present at both internal and external (regulatory) audits. May manage full time employees and/or contingent workers. Performs other duties assigned by Management. This role may be for you if you: Ability to work independently or as part of a team Ability to communicate with transparency Gathers and organizes information Effective time management skills Seeks to identify continuous improvement needs Gowning and Environment 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 attire To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and the following years experience for each level: QA Validation Specialist: 2 years Sr QA Validation Specialist: 5 years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. REGNQA Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location. 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $66,400.00 - $126,800.00

Keywords: Regeneron Pharmaceuticals, Inc., Schenectady , QA Validation Specialist (Fill Finish), Science, Research & Development , East Greenbush, New York