Build our future together:

Regeneron is seeking a Principal MSAT Engineer to join our Process Sciences Drug Product Engineering department. This role supports and/or leads equipment selection, CMO selection strategy, management of equipment qualification and/or process validation activities and will be hands-on solving issues during technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The Engineer also provides floor support during operations of internal or external manufacturing, reviews process data to ensure operational consistency after processes are successfully transferred and provides support for investigations.

When & where:

• Location: East Greenbush, New York, United States
• Work model: Monday-Friday, 8am-4:30pm 
• Travel percentage: 25-50% domestic & occasionally international

Discover your role:

• Serves as technical lead and subject matter expert for drug product manufacturing process transfer, providing oversight for new product introduction, technology transfer, and process troubleshooting/issue resolution
• Tracks and reports project milestones (raw material/component procurement, equipment readiness, analytical transfer, documentation) and partners with/leads cross-functional internal and external teams to ensure successful transfer execution
• Reviews and approves cGMP batch documentation (master batch records, specifications, validation protocols) and authors policies, technical reports, protocols, and change controls in support of cGMP activities
• Monitors cGMP compliance at drug product contract manufacturers to protect product integrity and company reputation
• Trends process performance to establish and improve process capability, ensuring operations remain within the intended control strategy
• Investigates deviations, determines root cause, and identifies/implements CAPA; develops sampling plans for GMP batches (lot release, stability, characterization)
• Collaborates with internal/external teams to identify and drive opportunities for improved process performance and cGMP operations
• Leads or assists in equipment selection, qualification, and start-up activities, and works with Manufacturing to ensure robust operating procedures
• Partners with Strategic Sourcing/Procurement to define technical requirements for raw materials, components, equipment, and services, ensuring on-time vendor delivery
• Works with DP MSAT management to define organizational structure, prioritize strategic initiatives, and assess staffing needs to support growth
• Leverages subject matter expertise to resolve emerging issues and escalates to line management as needed to manage impact
• Bring demonstrated technical knowledge in drug product manufacturing, product development, and validation, along with experience interacting with Contract Manufacturing Organizations
• Apply strong knowledge of industry practices and regulations (cGMP, Annex I) across multiple health authorities, including FDA, EMA, and MHRA

This role requires:

• BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred
  • Principal MSAT Engineer: 8+ years of relevant experience
  • Staff MSAT Engineer: 10+ years of relevant experience
• Level is determined based on qualifications relevant to the role

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.

Salary Range (annually)