Sr. Process Controls & Validation Engineer
Regeneron
2 hours ago
On-site
East Greenbush, NY
Operations
A typical day for a Sr. Process Controls and Validation Engineer might include:
- Developing and applying DP development tools to generate product-specific process recommendations that support clinical and commercial tech transfer across Regeneron’s global CMO network
- Establishing DP platform manufacturing processes for clinical manufacturing application across freeze/thaw, mixing, filtration, filling, and lyophilization unit operations
- Designing and qualifying small-scale laboratory models to generate data supporting process qualification execution
- Coordinating the development strategy for drug product tech transfers using risk-based tools aligned with ICH Quality by Design (QbD) principles and regulatory expectations
- Collaborating with cross-functional partners (modeling, technology transfer, formulation, and filling site counterparts) to guide study designs; review and approve protocols and reports; and ensure on-time delivery
- Analyzing product and process data using statistics, engineering principles, and risk-based decision-making to evaluate Critical to Quality Attributes (CQAs) and Critical Process Parameters (CPPs) across the product lifecycle
- Supporting audit readiness and contributing to CMC sections of regulatory submissions
This role might be for you if you:
- Have strong working knowledge of ICH guidelines, QbD principles, and risk-based approaches to drug product process development and validation
- Enjoy building structure in ambiguous spaces (e.g., new predictive tool, qualified model framework, new documentation)
- Are energized by cross-functional collaboration and can clearly translate complex technical concepts across development, manufacturing, quality, and regulatory
- Are willing to travel up to 10% annually to support CMO engagements and development activities
Requirements/Qualifications:
- Must be willing and able to work Monday–Friday, 8am–4:30pm
- B.S. in Engineering (chemical engineering, biochemical engineering, or related preferred)
- Sr. Process Controls and Validation Engineer: 5+ years
Preferred:
- Background in aseptic processing, drug product development, or biopharmaceutical process validation
Application:
- Apply now to take your first step.
- Developing and applying DP development tools to generate product-specific process recommendations that support clinical and commercial tech transfer across Regeneron’s global CMO network
- Establishing DP platform manufacturing processes for clinical manufacturing application across freeze/thaw, mixing, filtration, filling, and lyophilization unit operations
- Designing and qualifying small-scale laboratory models to generate data supporting process qualification execution
- Coordinating the development strategy for drug product tech transfers using risk-based tools aligned with ICH Quality by Design (QbD) principles and regulatory expectations
- Collaborating with cross-functional partners (modeling, technology transfer, formulation, and filling site counterparts) to guide study designs; review and approve protocols and reports; and ensure on-time delivery
- Analyzing product and process data using statistics, engineering principles, and risk-based decision-making to evaluate Critical to Quality Attributes (CQAs) and Critical Process Parameters (CPPs) across the product lifecycle
- Supporting audit readiness and contributing to CMC sections of regulatory submissions
This role might be for you if you:
- Have strong working knowledge of ICH guidelines, QbD principles, and risk-based approaches to drug product process development and validation
- Enjoy building structure in ambiguous spaces (e.g., new predictive tool, qualified model framework, new documentation)
- Are energized by cross-functional collaboration and can clearly translate complex technical concepts across development, manufacturing, quality, and regulatory
- Are willing to travel up to 10% annually to support CMO engagements and development activities
Requirements/Qualifications:
- Must be willing and able to work Monday–Friday, 8am–4:30pm
- B.S. in Engineering (chemical engineering, biochemical engineering, or related preferred)
- Sr. Process Controls and Validation Engineer: 5+ years
Preferred:
- Background in aseptic processing, drug product development, or biopharmaceutical process validation
Application:
- Apply now to take your first step.