GMP Process Characterization Engineer — Drug/Device Tech Transfer

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); In loco; USD 67.000 - 129.000; Tempo pieno

Descrizione del lavoro

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,

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GMP knowledge

Formazione

BS/BA in Engineering

Strumenti

DoE

JMP

Minitab

Descrizione del lavoro

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,