Sr. Process Controls & Validation Engineer
Regeneron
August 25, 2026
On-site
East Greenbush, NY
Operations
Discover Your Role
- Leads and provides hands-on support for cGMP process validation (Stage 1–3), technology transfer, design transfer, scale-up, and process control strategy development (protocol authoring through execution and lifecycle management)
- Evaluates product/process risk and applies engineering judgment to resolve gaps and uncertainty from development to at-scale manufacturing
- Analyzes process lifecycle data using statistics and engineering principles to inform control strategy/validation decisions and identify CPPs, control limits, and monitoring plans
- Leads and influences cross-functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory for process lifecycle management alignment
- Authors protocols, reports, and technical documents; ensures SOPs/policies/validation plans align with industry/regulatory expectations (e.g., ICH); supports audits/inspections and CMC regulatory submissions as needed
- Provides hands-on support for laboratory and manufacturing-scale studies
This Role Requires
- BS in Engineering; chemical engineering or biomedical engineering preferred
- Process Controls & Validation Engineer: 2+ years experience (or Sr.: 5+ years experience; level based on experience)
- Experience with process validation, technology transfer, and scale-up for drug substance
- Leads and provides hands-on support for cGMP process validation (Stage 1–3), technology transfer, design transfer, scale-up, and process control strategy development (protocol authoring through execution and lifecycle management)
- Evaluates product/process risk and applies engineering judgment to resolve gaps and uncertainty from development to at-scale manufacturing
- Analyzes process lifecycle data using statistics and engineering principles to inform control strategy/validation decisions and identify CPPs, control limits, and monitoring plans
- Leads and influences cross-functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory for process lifecycle management alignment
- Authors protocols, reports, and technical documents; ensures SOPs/policies/validation plans align with industry/regulatory expectations (e.g., ICH); supports audits/inspections and CMC regulatory submissions as needed
- Provides hands-on support for laboratory and manufacturing-scale studies
This Role Requires
- BS in Engineering; chemical engineering or biomedical engineering preferred
- Process Controls & Validation Engineer: 2+ years experience (or Sr.: 5+ years experience; level based on experience)
- Experience with process validation, technology transfer, and scale-up for drug substance