Process Validation Engineer (Fill Finish)

Regeneron Pharmaceuticals•Rensselaer, NY

6d•$62,355 - $110,000•Onsite

About The Position

Regeneron is seeking a Process Controls & Validation Engineer to join our Process Sciences Drug Product Engineering department. This non-lab based role focusing on fill finish operations provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer to post-commercial lifecycle management activities.

Requirements

BS/BA in Engineering, Chemical Engineering, Biomedical Engineering preferred
Process Controls & Validation Engineer: 2+ years of relevant experience
Sr. Process Controls & Validation Engineer: 5+ years of relevant experience
Level is determined based on qualifications relevant to the role

Nice To Haves

A background in aseptic processing/ fill finish, technology transfer, drug product process development, or biopharmaceutical process validation is preferred

Responsibilities

Supports technology transfer, process control strategy, validation, and post-commercialization activities
Evaluates product and process risks throughout the process lifecycle
Analyzes data from development, characterization, and at-scale manufacturing
Collaborates with Manufacturing, QC, QA, and CMC Regulatory to support process lifecycle management
Authors protocols, reports, and technical documents based on process and product knowledge
Ensures SOPs, policies, and validation plans align with industry and regulatory standards (e.g., ICH guidelines)
Supports audits, inspections, and CMC regulatory submissions
Applies engineering principles to develop and execute process controls and validation strategies
Uses statistical and engineering methods to assess manufacturing process performance
Supports laboratory and manufacturing-scale studies