Senior Process Development & Technology Engineer (Device Assembly)

Regeneron seeks a Process Development and Technology Engineer to develop, characterize, and scale GMP assembly processes for drug-delivery device combination products. The role involves process characterization, design of experiments, equipment qualification, and cross-functional coordination from technology transfer through commercial lifecycle management.

Responsibilities

• Guide process development and scale-up for GMP assembly of prefilled syringes, auto-injectors, and on-body injectors
• Plan and execute process characterization studies using Design of Experiments and statistical analysis to define operating ranges
• Develop in-process controls, sampling plans, and SPC monitoring strategies in collaboration with internal and external partners
• Support equipment and tooling qualification including URS/FRS/FAT/SAT and IQ/OQ/PQ activities
• Coordinate with QA, Regulatory Affairs, and CMOs to enable technology transfer and support regulatory submissions

Requirements

• Bachelor's degree in engineering or related field
• 2+ years experience in process development (Engineer level) or 5+ years (Senior level)
• Background in aseptic processing, drug product development, or biopharmaceutical validation
• Knowledge of 21 CFR Parts 210/211, ISO 13485, and ISO 14971 risk management
• Experience with Design of Experiments and statistical analysis tools (JMP, Minitab)
• Hands-on experience with equipment qualification (IQ/OQ/PQ, FAT/SAT, PPQ)
• Familiarity with QbD methodology and ICH Q8-Q11 guidelines