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About the Role

Regeneron is seeking a Process Controls & Validation Engineer with a strong background in cGMP validation to develop sound process control strategy, bring structure to ambiguous technical problems, and lead discussions across Manufacturing, Quality, and Regulatory teams. This role provides technical support for bulk manufacturing, quality, and CMC Regulatory throughout the product lifecycle.

Responsibilities

• Leads and provides 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.
• Translates ambiguous, early-stage problems into clear, actionable plans with limited direction.
• Evaluates product/process risk and applies engineering judgment to resolve gaps and uncertainty as processes move from development to at-scale manufacturing.
• Analyzes data across the process lifecycle using statistics and engineering principles to inform control strategy, validation decisions, and identify critical process parameters, control limits, and monitoring plans.
• Leads and influences cross-functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory, driving alignment and decisions on process lifecycle management.
• Authors protocols, reports, and technical documents grounded in available process/product knowledge.
• Ensures SOPs, policies, and validation plans align with industry/regulatory expectations (e.g., ICH).
• Supports audits/inspections and CMC sections of regulatory submissions as needed.
• Provides hands-on support for laboratory and manufacturing-scale studies, working effectively 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.
• Experience with process validation, tech transfer and scale up for drug substance.

Location

• Rensselaer, New York, United States

Work Type

• Onsite

Experience Level

• 2+ years
• 5+ years

Education Level

• BS in Engineering

Salary/Compensations

• $67,400.00 - $128,700.00

Benefits

• 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
• Family support benefits

About the Company

• At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
• Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor.
• We are committed to building a workplace with an inclusive culture.
• Regeneron offers a competitive and comprehensive total rewards package.

Equal Opportunity

• 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.