Process Characterization & Technology Engineer
About The Position
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.
Requirements
- 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
Nice To Haves
- Experience with autoinjectors, pen injectors, prefilled syringes is preferred
- Experience working with CMOs/CDMOs and executing tech transfer across sites is preferred
Responsibilities
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
