Senior Quality Assurance Validation Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Sr. QA Validation Specialist to join our Quality Assurance team. As the Senior QA Validation Specialist, you will validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Rensselaer, New York, United States

Monday-Friday, 8am-4:30pm

What you’ll do:

• Generates, executes 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
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
• 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 Executed real-world and simulated transport studies, including gross-damage visual inspections, pallet configuration assessments, and qualification of secondary and tertiary packaging materials
• Conducts temperature mapping for controlled environments and distribution lanes
• Programs and deploys instrumentation to capture vibration and shock profiles; analyzed data to inform packaging design and handling recommendations
• Programs humidity and pressure sensors and interpreted datasets to support test plans and root-cause analysis
• Applies ASTM and/or ISTA standards to cold-chain shipping design, testing, and qualification
• Performs small-parcel and palletized-load qualifications, including test planning, execution, and reporting
• 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
• Let’s find out if we’re a fit: Requires B.S in life sciences or related field; may substitute proven experience for education requirement QA Validation Specialist: 4 + years of experience
• Sr. QA Validation Specialist: 6+ years of experience
• Level will be determined based on experience
• Thrive today. Grow tomorrow.
• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)
• #REGNQA
• Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
• Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter.
• Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
• As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
• For jobs in Canada: this posting is for an existing position.