Process Characterization & Technology Engineer

BioSpace; Town of East Greenbush (NY); On-site; USD 62,000 - 110,000; Full time

Benefits offered by this job

Total rewards package

Onsite work model

Job summary

Regeneron in East Greenbush, NY is seeking a Process Characterization & Technology Engineer to join PSDPE. You will develop, characterize, and scale GMP assembly processes for drug-delivery device products and for packaging/labeling operations, applying QbD and ICH principles to control variability from clinical through commercial readiness.

The role involves cross-functional collaboration with QA, RA, CMOs, and manufacturing teams, using DoE, FMEA, and SPC to establish robust control

Qualifications

• BS in Engineering preferred.
• 0-2 years for Associate level; 2+ years for Engineer.
• Experience with autoinjectors or drug-delivery devices preferred.

Responsibilities

• Guide process development and scale-up for GMP assembly of drug-delivery devices.
• Translate QTPP to CQAs and develop risk-based characterization plans.
• Plan end-to-end process characterization using DoE and statistical analysis.
• Develop and implement in-process controls and sampling plans.
• Coordinate with QA, RA, and CMOs for tech transfer and regulatory support.
• Maintain documentation and ensure change control and CAPA effectiveness.

Skills

Process characterization

Scale-up

Quality by Design

GMP

Education

BS in Engineering (Mechanical/Biomedical/Chemical/Manufacturing)

Tools

JMP

Minitab

eQMS

Job description

Build Our Future TogetherAt 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 drugdelivery 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.

Build Our Future TogetherAt 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 drugdelivery 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 Youll 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 Q8Q11/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

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-at-regeneron/total-rewards/". For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $62,355.00 - $110,000.00