QA Validation Specialist - CMO & Partner Validation

The QA Validation department is hiring! The QA Validation Specialist for CMO & Partners provide Quality and Validation oversight of External validation/qualification activities of Vial/Syringe Filling, Assembly, and Packaging respective to equipment, systems, and processes in accordance with regulatory requirements. This position will require travel to our CMO and Partners on occasion and experience in equipment qualification and/or process qualification as it relates pharmaceutical fill finish and/or pack and label is desired.

As a QA Validation Specialist, a typical day might include the following:

• 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 acceptability of results against pre-determined criteria, investigates problems which occur and crafts solutions or recommendations for changes and/or improvements.
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions in addition to controls, SOPs, reports and other documentation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks, while handling projects and preparing status reports.
• May require 10-25% travel to CMO & Partner sites annually

You might be our next QA Validation Specialist if you have the ability to

• Maintain integrity and honesty at all times
• Work independently or as part of a team, communicate with clarity and demonstrate respectful behavior at all times
• Continuously strive to improve processes for improved performance
• Basic knowledge of Microsoft Suite (Word, Excel, Powerpoint)
• Meets commitments on time, has effective time management skills and can coordinate information from multiple sources
• Represent Regeneron and reflect values, and mission of the company when communicating internally and externally

In order to be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and

• 0 – 2 years of relevant experience for an Associate
• 2+ years of relevant experience for a Specialist
• 5+ years of relevant experience for a Senior Specialist
• May substitute experience for education requirement

#REGNQA #LI-Hybrid

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$55,700.00 - $121,300.00