Senior cGMP Process Controls & Validation Engineer

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

Job summary

Regeneron Pharmaceuticals, East Greenbush, NY, is seeking a Process Controls & Validation Engineer with a strong background in cGMP validation. You will lead process validation, tech transfer, scale-up and design a robust control strategy across manufacturing, quality and regulatory teams.

The role requires a BS in Engineering (chemical or biomedical preferred) and 2+ years for Engineer or 5+ years for Senior Engineer, with onsite work and a Monday–Friday schedule.

Qualifications

• BS in Engineering, chemical or biomedical preferred.
• 2+ years Process Controls & Validation Engineer experience.
• 5+ years Sr. Process Controls & Validation Engineer experience.
• Experience with process validation, tech transfer and scale up for drug substance.

Responsibilities

• Leads hands-on support for cGMP process validation (Stage 13), technology transfer, design transfer, scale-up, and process control strategy development.
• Evaluates product/process risk and applies engineering judgment to resolve gaps and uncertainty as processes move from development to at-scale manufacturing.
• Analyzes data across the process lifecycle from development through characterization and manufacturing history to inform control strategy and monitoring plans.
• Leads cross-functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory.
• Authors protocols, reports, and technical documents; supports audits/inspections and CMC submissions as needed.
• Provides hands-on support for lab and manufacturing-scale studies in a team environment.

Skills

Process controls

Validation engineering

Data analysis

Cross-functional leadership

Technology transfer

Regulatory knowledge

Education

BS in Engineering

Chemical/biomedical preferred

Job description

Regeneron Pharmaceuticals, East Greenbush, NY, is seeking a Process Controls & Validation Engineer with a strong background in cGMP validation. You will lead process validation, tech transfer, scale-up and design a robust control strategy across manufacturing, quality and regulatory teams.

The role requires a BS in Engineering (chemical or biomedical preferred) and 2+ years for Engineer or 5+ years for Senior Engineer, with onsite work and a Monday–Friday schedule.