Process Characterization & Technology Engineer

Regeneron; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Regeneron is seeking a Process Characterization & Technology Engineer in East Greenbush, NY. You will lead DoE-driven process characterization and scale-up for GMP assembly of drug-delivery devices, packaging, and labeling operations.

You will implement QbD methodologies, develop control strategies, and collaborate across QA, RA, Device Engineering, CMC, and CMOs to ensure regulatory compliance and successful tech transfer from clinical to commercial readiness.

Qualifications

• BS in Engineering, Mechanical, Biomedical, Chemical, or Manufacturing Engineering preferred.
• 0–2 years for Associate; 2+ years for Engineer level, based on experience.
• Experience with autoinjectors, pen injectors, or prefilled syringes is preferred.
• Experience with CMOs/CDMOs and tech transfer across sites is preferred.

Responsibilities

• Guide process development and scale-up for GMP assembly of combination products.
• Translate the QTPP into CQAs and develop control strategies using ICH principles.
• Plan and execute end-to-end process characterization with DoE and statistics.
• Develop in-process controls, sampling plans, PPQ approaches, and SPC.
• Coordinate with QA, RA, Device Engineering, and CMOs for tech transfer.
• Author and maintain reports, SOPs, and electronic records; manage deviations and CAPAs.
• Support packaging and labeling processes, serialization, and distribution simulation.

Skills

DoE

Statistical analysis

FMEA

Process characterization

Quality by Design (QbD)

JMP

Minitab

Documentation best practices

GMP knowledge

Education

BS in Engineering

Tools

eQMS

MES

LIMS

URS/FRS

FAT/SAT

IQ/OQ/PQ

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently looking for a Process Characterization & Technology Engineer to join our Process Sciences Drug Product Engineering (PSDPE) department. This technical services department handles a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. The Process Characterization & Technology Engineer will develop, characterize, and scale GMP assembly processes for drug-delivery device combination products, as well as for packaging and labeling operations. You will apply design controls, ICH, and Quality by Design (QbD) methodologies to define sources of process variability and in-process controls, and deliver robust, compliant manufacturing capability from clinical through commercial readiness.

When & where

Location: East Greenbush, New York, United States

Work model: Monday-Friday, 8am-4:30pm

What you'll do

• Guide process development and scale-up for GMP assembly of combination products (prefilled syringes, autoinjectors, on-body injectors).
• Translate the QTPP into CQAs, build risk-based characterization plans, identify CPPs, and develop control strategies using ICH Q8-Q11/Q9 principles and FMEA.
• Plan and execute end-to-end process characterization using DoE and statistical analysis (JMP, Minitab) and engineering studies to define operating ranges and limits.
• Develop and implement in-process controls (IPCs), sampling plans (e.g., AQL), PPQ approaches, and SPC/capability monitoring with internal and external partners.
• Contribute to equipment and tooling qualification, including URS/FRS, FAT/SAT, IQ/OQ/PQ, and CPV.
• Apply the same DoE, qualification, and control-strategy approaches to packaging and labeling processes, print/vision inspection, serialization/UDI, tamper evidence, and transport/distribution simulation.
• 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 tech transfer and operational readiness, and support regulatory filings with clear process narratives and summaries.
• Apply practical knowledge of 21 CFR Parts 4, 210/211, 820; ISO 13485; and ISO 14971 risk management.
• Support packaging and labeling lines, including print inspection, barcode/2D codes, serialization/UDI, line clearance, and artwork control.
• Maintain strong documentation practices using electronic systems (e.g., eQMS, MES, LIMS) and demonstrate ownership of deviations, CAPAs, and change records.

This role requires

• BS in Engineering, Mechanical, Biomedical, Chemical, or Manufacturing Engineering is preferred Associate Process Controls & Validation Engineer: 0-2 years of experience.
• Process Controls & Validation Engineer: 2 + years of experience Level will be determined based on experience.
• Experience with autoinjectors, pen injectors, prefilled syringes is preferred.
• Experience working with CMOs/CDMOs and executing tech transfer across sites is preferred.

Does this sound like you?

We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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 information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-a