Sr. Process Controls & Validation Engineer

Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Process Controls & Validation Engineer with a strong background in cGMP validation to develop sound process control strategies, bring structure to ambiguous technical problems, and confidently lead and influence discussions across Manufacturing, Quality, and Regulatory teams.

About the role

Process Sciences is a technical services department that addresses scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. This role provides technical support to bulk manufacturing, quality, and CMC Regulatory for manufacturing processes—from technology transfer and/or design transfer to post-commercial lifecycle management activities.

Responsibilities

• Lead and provide hands-on support for cGMP process validation (Stage 1-3), technology transfer, design transfer, scale-up, and process control strategy development, from protocol authoring through execution and lifecycle management.
• Translate ambiguous, early-stage problems into clear, actionable plans with limited direction.
• Evaluate product/process risk and apply engineering judgment to resolve gaps and uncertainty as processes move from development to at-scale manufacturing.
• Analyze data across the process lifecycle—from development through characterization and manufacturing history—using statistics and engineering principles to inform control strategy, validation decisions, and identify critical process parameters, control limits, and monitoring plans.
• Lead and influence cross-functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory, driving alignment and decisions on process lifecycle management while navigating differing stakeholder priorities.
• Author protocols, reports, and technical documents grounded in available process/product knowledge; ensure SOPs, policies, and validation plans align with industry/regulatory expectations (e.g., ICH).
• Support audits/inspections and CMC sections of regulatory submissions as needed.
• Provide hands-on support for laboratory and manufacturing-scale studies in a team-oriented environment.

Requirements

• BS in Engineering; chemical engineering or biomedical engineering preferred.
• Process Controls & Validation Engineer: 2+ years of experience.
• Sr. Process Controls & Validation Engineer: 5+ years of experience (level determined based on experience).
• Experience with process validation, technology transfer, and scale-up for drug substance.

Pay

Salary Range (annually): $67,400.00 - $128,700.00.

Schedule

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

Benefits

Regeneron offers a competitive and comprehensive total rewards package, which may include:

• 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 details about Regeneron benefits in the U.S., visit Regeneron Total Rewards. For other locations, information will be provided during the recruitment process.

Location: Rensselaer, New York, United States.