Principal Quality Assurance Validation Specialist, Sterility

Regeneron Pharmaceuticals, Inc.; New York (NY); Presencial; USD 92.000 - 151.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Principal QA Validation Specialist to lead the utilities and EMPQ team for our internal fill-finish facility.

You will oversee qualification of utilities, cleanrooms, and filling lines critical to commercial production, ensuring regulatory compliance and strong contamination control. The role requires 8+ years in utility/facility qualification, cGMP experience, and excellent cross-functional collaboration.

Formación

• 8+ years of relevant experience in validation/qualification in a GxP environment.
• Experience with utilities and facility qualification/validation.
• Gowning in cleanroom environments and cGMP knowledge.
• Strong cross-functional collaboration and communication skills.

Responsabilidades

• Lead validation and SME for utilities and environmental qualification; review changes and CAPAs.
• Plan and execute cleanroom qualifications and EMPQ for filling lines.
• Drive QRM deliverables including HACCP assessments and trend reporting.
• Lead investigations of contamination events in cleanrooms and related equipment.
• Qualify critical utilities: WFI, clean air, AHUs, clean steam, nitrogen systems.
• Develop team and consultants to meet project milestones and deliverables.
• Ensure regulatory compliance, participate in Annex 1 gap assessments.

Conocimientos

Utilities qualification

Environmental qualification

Gowning/cleanroom

Cross-functional collaboration

Regulatory compliance

Educación

BS/BA in Engineering, Chemistry, or Life Sciences

Descripción del empleo

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Quality Assurance (QA) Validation Specialist to join our QA Validation team. They will lead the utilities and Engineering / Manufacturing Process Qualification (EMPQ) team for our internal fill finish facility, overseeing qualification of utilities, cleanrooms, and filling lines critical to commercial production; ensure regulatory compliance, strengthen the contamination control strategy, and drive key licensure activities.

When & where:

Location: Rensselaer, New York, United States

Work model: Monday-Friday, 8am-4:30pm

Discover your role:

• Lead validation and serve as SME for utilities and environmental qualification; assess change controls, review CAPAs/NOEs, approve documents, and lead audits
• Plan and execute cleanroom qualifications and requalification; oversee EMPQ for filling line clean air equipment
• Drive Quality Risk Management (QRM) deliverables including Hazard Analysis and Critical Control Points (HACCP) assessments and continuous trending/reporting
• Lead investigations of contamination events associated with environmental monitoring in cleanrooms and clean air equipment
• Qualify critical utilities: Water for Injection (WFI), pharmaceutical air, AHUs, clean steam generators, and nitrogen distribution systems
• Manage and develop a specialist and a team of consultants to meet project milestones and deliver qualification/documentation deliverables
• Establish processes that ensure compliance with regulatory requirements, including participation in Annex 1 gap assessments
• Influence the creation and revision of local/global policies, standards, procedures, and business processes to align with industry best practices
• Demonstrated experience in a cGMP-regulated environment, including validation, inspection and audit readiness
• Possesses strong cross-functional collaboration and communication skills

This role requires:

• BS/BA in Engineering, Chemistry, or Life Sciences and 8+ years of relevant experience
• Experience in utility and facility qualification/validation
• Gowning: 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

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.

We are committed to building a workplace with an inclusive culture.

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.

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.

Salary Range (annually) $92,200.00 - $150,600.00

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. On-site expectations for your role and location will be discussed during the recruitment process.