Process Validation Engineer (Fill Finish)

About the role

Regeneron is seeking a Process Controls & Validation Engineer to join our Process Sciences Drug Product Engineering department. Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. 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.

Location & Schedule

East Greenbush, New York, United States. Monday-Friday, 8am-4:30pm.

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

Environment & Physical Requirements

Full cleanroom attire required (including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents including IPA). Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire.

Qualifications

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