Senior Fill Finish Manufacturing Engineer

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Fill/Finish Manufacturing Engineer to join our Manufacturing organization, supporting our fill/finish operations team on-site. In this role, you will serve as the technical subject matter expert for medical device and combination product assembly design and selection as well as process development activities. You will be hands-on problem solving issues during technology transfer, cGMP start-up, and routine manufacturing for Regeneron internal processes. This role will also support validation and training activities for targeted equipment, processes, and operators.

Responsibilities

• Acts as the technical subject matter expert for assembly, labeling, and packaging processes
• Serves as the primary interface between operations and Engineering, Combination Products, Validation, and Quality Assurance
• Leads material and component selection, design, and approval in partnership with internal stakeholders and external vendors
• Supports equipment and new technology design, installation, and qualification, along with technology transfer studies and investigations
• Drives innovation in fill/finish manufacturing equipment and techniques, recommending capital investments to support continuous improvement
• Represents manufacturing during regulatory and client audits
• Fosters a positive team environment by listening closely to team members and stakeholders while driving toward shared goals
• Brings strong interpersonal, cross-cultural, and communication skills alongside confidence, emotional intelligence, and creative problem-solving

Requirements

• Bachelor's degree in Engineering
• 5+ years of related experience (level determined based on qualifications)
• Knowledge of cGMP manufacturing environments
• Familiarity with assembly, labeling, and packaging of liquid and lyophilized injectable products

Preferred Qualifications

• Experience operating and qualifying highly automated equipment, including serialization systems
• Technology transfer and equipment/process validation experience in aseptic, parenteral fill/finish operations
• Previous experience providing technical support