Fill-Finish Process Controls & Validation Engineer

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

401(k) match

Health benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls & Validation Engineer in East Greenbush, NY. The role focuses on fill-finish operations, providing technical support from tech transfer to lifecycle management of manufacturing processes.

The position requires a BS/BA in Engineering and 2+ years (senior level 5+ years). Knowledge of aseptic processing and regulatory considerations is preferred; salary is listed and a comprehensive rewards program applies.

Qualifications

• BS/BA in Engineering (Chemical/Biomedical preferred).
• Process controls and validation experience required.
• Knowledge of ICH guidelines and regulatory expectations.

Responsibilities

• Supports tech transfer, process control strategy, validation and post-commercial activities.
• Evaluates product and process risks throughout the lifecycle.
• Analyzes data from development, characterization and scale-up.
• Collaborates with Manufacturing, QC, QA, and CMC Regulatory.
• Authors protocols, reports and technical documents.
• Ensures SOPs and validation plans meet industry standards.
• Supports audits, inspections and regulatory submissions.
• Applies engineering methods to develop process controls and validation.
• Uses statistics to assess manufacturing performance.
• Supports lab and manufacturing-scale studies.

Skills

Process controls

Validation

Data analysis

Regulatory knowledge

Education

BS/BA in Engineering

Tools

Statistical methods

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls & Validation Engineer in East Greenbush, NY. The role focuses on fill-finish operations, providing technical support from tech transfer to lifecycle management of manufacturing processes.

The position requires a BS/BA in Engineering and 2+ years (senior level 5+ years). Knowledge of aseptic processing and regulatory considerations is preferred; salary is listed and a comprehensive rewards program applies.