Principal QA Validation Specialist (Equipment Qualification)

Location: Troy
Posted on: June 23, 2025

Job Description:

Regeneron is hiring a Principal QA Validation Specialist (Equipment Qualification)! In this role, you will play a critical part in ensuring the validation and qualification of equipment, systems, and processes at our IOPS Manufacturing facilities in Rensselaer, NY. In this role, a typical day might include the following: Collaborating with cross-functional teams, including manufacturing, engineering, and external contractors/vendors, to complete equipment validation tasks. Managing equipment validation projects and preparing detailed status reports. Supervising and providing direction to team members involved in equipment validation activities. Investigating and troubleshooting equipment-related issues and recommending solutions or improvements. Generating, implementing, and/or reviewing equipment qualification protocols (IQ/OQ/PQ), summary reports, and associated data for compliance with regulations, SOPs, specifications, and acceptance criteria. Conducting equipment validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Analyzing test results to determine equipment performance and compliance with pre-determined criteria. Reviewing and approving deviation notifications, investigations, corrective actions, and change controls related to equipment qualification. Supporting internal and external audits by presenting documentation and validation results. Performing other duties as assigned by management. This role may be for you if you have: Ability to work independently or as part of a team. Continuously drive to improve processes for improved performance. Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint). Effective time management skills. Seeks to identify continuous improvement needs. To be considered for this position, you must hold a BS/BA in Engineering, Life Sciences, or related field and the following years of experience for each level: Sr QA Validation Specialist: 5 years Principal QA Validation Specialist: 8 years Level is determined based on qualifications relevant to the role. May substitute proven experience for education requirement. REGNQA Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 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) $77,600.00 - $148,400.00

Keywords: , East Hartford , Principal QA Validation Specialist (Equipment Qualification), Engineering , Troy, Connecticut