Senior GMP Process Development Engineer — Drug Device Tech

BioSpace; Town of East Greenbush (NY); On-site; USD 67,000 - 129,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k)

Health insurance

Paid time off

Family support benefits

Job summary

Regeneron is seeking a hands-on Process Characterization and Technology Engineer in East Greenbush, NY. This role focuses on developing, characterizing, and scaling GMP assembly processes for drug-delivery device combination products, as well as packaging and labeling operations.

You will transfer technology across manufacturing, quality, and CMC regulatory teams, support DoE studies, process control strategies, and regulatory filings with clear process narratives.

Qualifications

• BA/BS in Engineering with 2+ years proven experience.
• Sr Engineer: BS/BA in Engineering with 5+ years proven experience.
• Experience with aseptic processing or biopharmaceutical/combination product validation preferred.

Responsibilities

• Guide process development and scale-up for GMP assembly of combination products (prefilled syringes, auto injectors, on-body injectors).
• Translate the QTPP into CQAs, plan risk-based characterization experiments, identify CPPs, and build a control strategy using ICH Q8/Q11 and Q9.

Skills

Process development

Scale-up

DoE

SPC analysis

QbD

Tech transfer

FMEA

Quality systems

Education

BS in Engineering

Tools

JMP

Minitab

Job description

Regeneron is seeking a hands-on Process Characterization and Technology Engineer in East Greenbush, NY. This role focuses on developing, characterizing, and scaling GMP assembly processes for drug-delivery device combination products, as well as packaging and labeling operations.

You will transfer technology across manufacturing, quality, and CMC regulatory teams, support DoE studies, process control strategies, and regulatory filings with clear process narratives.