Sr. Process Controls & Validation Engineer

Job description

Regeneron is currently looking for a Sr. Process Controls and Validation Engineer to join the Drug Product Process Sciences team. In this non-lab based role, you will serve as a technical driver for the at-scale process development and technology transfer of drug product manufacturing processes — from clinical tech transfer through process validation and commercial lifecycle management — across Regeneron's global CMO network. 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 in alignment with ICH Quality by Design (QbD) principles and regulatory expectations Collaborating with cross-functional pa...