Process Validation Engineer (Fill Finish

Process Controls & Validation Engineer

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.

When & where:

• Location:
  
  East Greenbush, New York, United States
• Work model:
  Monday-Friday, 8am-4:30pm

Discover your role:

• 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

The environment and physical rhythms of the role:

• Gowning:
  Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

This role requires:

• 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