Process Validation Engineer (Fill Finish)

About the Role

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

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

Work Environment

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

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

Requirements

• BS/BA in Engineering (Chemical Engineering or 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

Pay

Salary Range (annually): $62,355.00 - $110,000.00

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits, 401(k) company match
• Health and wellness programs, fitness centers
• Insurance benefits (e.g., medical, dental, vision, life, and disability)
• Paid time off
• Family support benefits

For additional information about Regeneron benefits in the U.S., visit Regeneron Total Rewards. For other locations, additional information will be provided during the recruitment process.