Principal QA Validation Specialist (Fill/Finish)

Our QA Fill Finish Validation team is hiring a Principal QA Validation Specialist to validate and qualify equipment, systems, and processes in compliance with regulatory standards. Support our newly constricted Fill Finish Facility in Upstate NY and contribute to a fast-paced, innovative environment. 

In this role, a typical day might include the following: 

• Lead validation efforts for equipment, processes, and systems (including IQ, OQ, PQ). 

• Act as a Technical SME (Subject Matter Expert) in areas including Equipment Qualification, Drug Product Filling Validation, and Automated/Semi-Automated Visual Inspection. 

• Validate equipment such as Syringe/Vial Fillers, Inspection Machines, Packaging Machines, and Finished Goods handling systems. 

• Must be able to present in a “pressure test” scenario the technical area they are SME for. 

• Generate, review, and approve master and complete qualification validation protocols, reports, SOPs, and change controls. 

• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. 

• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines. 

• May present at both internal and external (regulatory) audits. 

This role may be for you if you: 

• Have expertise in validation processes including automated/semi-automated visual inspection and finished goods handling. 

• Ability to communicate with transparency. 

• Continuously aim to improve processes for improved performance. 

• Have strong communication, time management, and problem-solving skills. 

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: 

• Sr QA Validation Specialist: 5+ years 

• Principal QA Validation Specialist: 8+ years 

• Staff QA Validation Specialist: 10+ 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 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.

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