Senior Process Development & Technology Engineer (Device Assembly)

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY is seeking a hands-on Process Characterization and Technology Engineer to develop, characterize, and scale GMP assembly processes for drug–delivery device products.

The role also supports packaging and labeling operations and collaborates with QA and CMC Regulatory for tech transfer and lifecycle management. The candidate will translate QTPP to CQAs, design DoE-based characterization plans, define CPPs, and build a robust control strategy,

Qualifications

• BS/BA in Engineering or related field is required.
• Engineer: BS/BA in Engineering with 2+ years proven experience.
• Sr Engineer: BS/BA in Engineering with 5+ years proven experience.

Responsibilities

• Guide process development and scale-up for GMP assembly of combination products (prefilled syringes, auto injectors, on-body injectors).
• Translate QTPP into CQAs; plan characterization experiments; identify CPPs; build control strategy per ICH Q8-Q11 & Q9.
• Plan end-to-end process characterization using DoE, statistics, and engineering studies to define operating ranges and limits.
• Collaborate on development and implementation of in-process controls, sampling plans, PPQ approaches, and SPC monitoring.
• Contribute to equipment/tooling qualification (URS/FRS/FAT/SAT/IQ/OQ/PQ).
• Support packaging and labeling processes, print/vision inspection, serialization, tamper evidence, and distribution simulations.
• Authors reports, SOPs, and change controls; support deviations and CAPA effectiveness.
• Coordinate with QA, RA, Device Engineering, CMC, Supply Chain, and CMOs for tech transfer and regulatory filings.

Skills

GMP knowledge

Education

BS/BA in Engineering

Tools

DoE

JMP

Minitab

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are 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 for packaging and labeling operations. This person will provide technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

When & Where

• Location: East Greenbush, NY
• Shift Requirements: Monday-Friday- 8-4:30pm
• Travel: 10-20% domestic- sometimes international

Discover Your Role

• Guide process development and scale-up for GMP assembly of combination products (prefilled syringes, auto injectors, on-body injectors)
• Translate the Quality Target Product Profile (QTPP) into Critical Quality Attributes (CQAs), make risk-based plans for 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 development and implementation of in-process controls (IPCs), sampling plans, PPQ approaches, and SPC monitoring with internal and external partner groups
• Contribute to qualification of equipment and tooling, URS/FRS/FAT/SAT and IQ/OQ/PQ
• Support packaging and labeling processes, print/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 tech transfer and operational readiness; support regulatory filings with clear process narratives and summaries

This Role Requires

• BA/BS in Engineering related field
• Engineer: BS/BA in Engineering with 2+ years proven experience
• Sr Engineer: BS/BA in Engineering with 5+ years proven experience

Highly Preferred Qualifications

• A background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation
• Experience with auto-injectors, pen injectors, prefilled syringes
• Practical knowledge of 21 CFR Parts 4, 210/211, 820; ISO 13485; and ISO 14971 risk management
• Knowledge of sterilization modalities and implications for materials and packaging (e.g., EtO, gamma, e-beam)
• Experience working with CMOs/CDMOs and delivering tech transfers across sites
• Knowledge of QbD and ICH Q8-Q11, 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; solid understanding of SPC, capability measures, and sampling plans (e.g., AQL)
• Hands-on experience with equipment URS, FAT/SAT, IQ/OQ/PQ, PPQ, and CPV

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. If you have any questions, please speak with your recruiter.

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 on-site. Please speak with your recruiter and hiring manager for more information about on-site 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)

$67,400.00 - $128,700.00