Senior Process Development & Technology Engineer (Device Assembly)
Regeneron Pharmaceuticals
Summary
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.
Job description
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
Requirements
- BA/BS in Engineering related field
- BS/BA in Engineering with 2+ years proven experience (Engineer level)
- BS/BA in Engineering with 5+ years proven experience (Sr Engineer level)
- 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
Benefits
- Annual Bonuses
- Incentive Plans
- Equity Awards
- Pension or Retirement Benefits
- 401(k) Company Match
- Health and Wellness Programs
- Fitness Centers
- Medical, Dental & Vision Insurance
- Life and Disability Insurance
- Paid Time Off
- Family Support Benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.