Senior cGMP Process Controls & Validation Engineer

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

Job summary

Regeneron is seeking a Process Controls & Validation Engineer in Rensselaer, NY to lead cGMP validation and develop robust process control strategies across manufacturing and quality teams.

The role involves technology transfer, design transfer, scale-up, and lifecycle management of manufacturing processes, with emphasis on translating ambiguous problems into actionable plans and ensuring regulatory alignment.

Qualifications

• BS in Engineering; chemical or biomedical engineering preferred.
• 2+ years of process validation and tech transfer experience.
• Experience with cGMP validation and process lifecycle management.

Responsibilities

• Leads cGMP process validation (Stage 1–3) and technology transfer.
• Develops and implements process control strategies.
• Collaborates with Manufacturing, Quality, and Regulatory teams.
• Documents protocols and supports regulatory submissions.
• Provides hands-on support for lab and manufacturing scale studies.

Skills

cGMP validation

Process controls

Design transfer

Tech transfer

Scale-up

Education

BS in Engineering

Chemical engineering

Biomedical engineering

Job description

Regeneron is seeking a Process Controls & Validation Engineer in Rensselaer, NY to lead cGMP validation and develop robust process control strategies across manufacturing and quality teams.

The role involves technology transfer, design transfer, scale-up, and lifecycle management of manufacturing processes, with emphasis on translating ambiguous problems into actionable plans and ensuring regulatory alignment.