Senior cGMP Process Controls & Validation Engineer

Regeneron Pharmaceuticals, Inc; Town of East Greenbush (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls & Validation Engineer to lead cGMP process validation and technology transfer from development through commercial scale.

The role involves translating early-stage problems into actionable plans and coordinating with Manufacturing, Quality, and Regulatory teams. The candidate will analyze lifecycle data to inform control strategies, set critical parameters, and develop monitoring plans while ensuring compliance with ICH standards.

Qualifications

• Experience with cGMP process validation (Stage 1-3).
• Ability to lead technology transfer and scale-up activities.
• Ability to analyze data across the process lifecycle using statistics and engineering principles.

Responsibilities

• Lead and provide hands-on support for cGMP process validation, technology transfer, design transfer, scale-up, and process control strategy development.
• Evaluate product/process risk and resolve gaps as processes move to manufacturing.
• Author protocols, reports, and validation documents aligned with ICH guidelines.

Skills

Process validation

Tech transfer

cGMP

Data analysis

Education

BS in Engineering

Chemical or Biomedical Engineering preferred

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls & Validation Engineer to lead cGMP process validation and technology transfer from development through commercial scale.

The role involves translating early-stage problems into actionable plans and coordinating with Manufacturing, Quality, and Regulatory teams. The candidate will analyze lifecycle data to inform control strategies, set critical parameters, and develop monitoring plans while ensuring compliance with ICH standards.