Principal Manufacturing Sciences & Technology Engineer

About the Role

The Principal MSAT Engineer will join the Process Sciences Drug Product Engineering department, supporting and leading equipment selection, CMO selection strategy, and management of equipment qualification and process validation activities. This hands-on role involves troubleshooting during technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations.

The Engineer provides floor support during internal or external manufacturing operations, reviews process data to ensure consistency, and supports investigations. The role also involves serving as a technical lead and subject matter expert for drug product manufacturing process transfers, overseeing new product introduction, technology transfer, and process troubleshooting.

Responsibilities

• Track and report project milestones (raw material/component procurement, equipment readiness, analytical transfer, documentation) and partner with or lead cross-functional teams to ensure successful transfer execution.
• Review and approve cGMP batch documentation (master batch records, specifications, validation protocols) and author policies, technical reports, protocols, and change controls in support of cGMP activities.
• Monitor cGMP compliance at drug product contract manufacturers to protect product integrity and company reputation.
• Trend process performance to establish and improve process capability, ensuring operations remain within the intended control strategy.
• Investigate deviations, determine root cause, and identify/implement CAPA; develop sampling plans for GMP batches (lot release, stability, characterization).
• Collaborate with internal and external teams to identify and drive opportunities for improved process performance and cGMP operations.
• Lead or assist in equipment selection, qualification, and start-up activities, and work with Manufacturing to ensure robust operating procedures.
• Partner with Strategic Sourcing/Procurement to define technical requirements for raw materials, components, equipment, and services, ensuring on-time vendor delivery.
• Work with DP MSAT management to define organizational structure, prioritize strategic initiatives, and assess staffing needs to support growth.
• Leverage subject matter expertise to resolve emerging issues and escalate to line management as needed.

Requirements

• BS/BA in Engineering (Chemical Engineering or Biomedical Engineering preferred).
• Principal MSAT Engineer: 8+ years of relevant experience.
• Staff MSAT Engineer: 10+ years of relevant experience (level determined based on qualifications).
• Demonstrated technical knowledge in drug product manufacturing, product development, and validation.
• Experience interacting with Contract Manufacturing Organizations (CMOs).
• Strong knowledge of industry practices and regulations (cGMP, Annex I) across multiple health authorities, including FDA, EMA, and MHRA.

Schedule

Monday-Friday, 8:00 AM - 4:30 PM.

Travel percentage: 25-50% domestic and occasionally international.

Pay

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

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., visit Regeneron Total Rewards. For other locations, details will be provided during the recruitment process.