Senior Process Development & Technology Engineer (Device Assembly)

Regeneron Pharmaceuticals • Valley, AL

6d • $67,400 - $128,700 • Onsite

About The Position

Regeneron is seeking a hands-on Process Characterization and Technology Engineer to develop, characterize, and scale GMP assembly processes for drug-delivery device combination products, as well as packaging and labeling operations. The role provides technical support to manufacturing, quality, and CMC Regulatory for manufacturing processes from technology or design transfer through post-commercial lifecycle management. The position is based in East Greenbush, New York, with a Monday–Friday, 8:00 a.m.–4:30 p.m. schedule and 10–20% domestic travel, sometimes internationally.

Requirements

• BA/BS in an engineering-related field.
• For the Senior Engineer level: a bachelor's degree in engineering and 5 or more years of proven experience.

Nice To Haves

• Background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation.
• Experience with auto-injectors, pen injectors, or prefilled syringes.
• Practical knowledge of 21 CFR Parts 4, 210/211, and 820; ISO 13485; and ISO 14971 risk management.
• Knowledge of sterilization modalities and their implications for materials and packaging, such as EtO, gamma, and e-beam.
• Experience working with CMOs/CDMOs and delivering technology transfers across sites.
• Knowledge of QbD, ICH Q8–Q11, and Q9 methodologies to define CQAs, CPPs, CMAs, risk assessments (FMEA), and control strategies.
• Knowledge of DoE and statistical analysis using tools such as JMP or Minitab, and understanding of SPC, capability measures, and sampling plans such as AQL.
• Hands-on experience with equipment URS, FAT/SAT, IQ/OQ/PQ, PPQ, and CPV.

Responsibilities

• Guide process development and scale-up for GMP assembly of combination products, including prefilled syringes, auto-injectors, and on-body injectors.
• Translate the Quality Target Product Profile (QTPP) into Critical Quality Attributes (CQAs), plan risk-based characterization experiments, identify Critical Process Parameters (CPPs), and build a control strategy using ICH Q8–Q11 and Q9 principles.
• Plan and implement end-to-end process characterization using Design of Experiments (DoE), statistical analysis, and engineering studies to define operating ranges and limits.
• Collaborate on the development and implementation of in-process controls (IPCs), sampling plans, Process Performance Qualification (PPQ) approaches, and Statistical Process Control (SPC) monitoring with internal and external partner groups.
• Contribute to equipment and tooling qualification, including URS/FRS/FAT/SAT and IQ/OQ/PQ.
• Support packaging and labeling processes, print and vision inspection, serialization, tamper evidence, and transport and distribution simulation where applicable.
• Author and maintain reports, SOPs, work instructions, and electronic records; ensure compliant change control, deviation investigations, and CAPA effectiveness.
• Coordinate with QA, RA, Device Engineering, CMC, Supply Chain, and external CMOs to enable technology transfer and operational readiness.
• Support regulatory filings with clear process narratives and summaries.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior