Sr QA Validation Specialist

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients

In this role you will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

As a Sr QA Validation Specialist a typical day might include, but is not limited to, the following:

• Generate, execute and/or review master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Analyze the results of testing and resolve acceptability of results against pre-determined criteria
• Investigate and troubleshoot problems which occur and determines solutions or recommendations for changes and/or improvements
• Review, edit and approve deviation notifications, deviation investigations, and corrective actions
• Review, edit and approve change controls, SOPs, reports and other documentation
• Coordinate with other departments or outside contractors/vendors to complete validation tasks
• Train/advise less experienced Specialists
• Lead projects and prepares status reports
• May be required to supervise contingent workers
• Other duties assigned by management

This role might be for you if you demonstrate the following:

• Ability to maintain integrity and honesty at all times
• Ability to work independently or as part of a team
• Ability to communicate with transparency
• Continuously drive to improve processes for improved performance
• Demonstrate respectful behavior at all times
• Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint)
• Captures and organizes information
• Meets commitments on time
• Follows directions; performs well-defined tasks
• Effective time management skills
• Seeks to identify continuous improvement needs

To be considered for this role you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the field preferred; may substitute relevant experience for education.

#REGNQA #IRELIM #JOBSIEST #LI-Onsite #REGNIEQA

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.