Principal Manufacturing Process Engineer

About the role

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re seeking a Principal Manufacturing Process Engineer to join our Global Manufacturing team. In this role, you will provide technical support for bulk manufacturing processes across sites, as well as engineering support and problem solving for existing equipment and manufacturing processes. This position may have direct report/ supervisory responsibility. Location: Saratoga Springs, New York, United States.

Responsibilities

• Review process data, identify and report shifts or outliers
• Create opportunities to improve process reliability, repeatability, compliance and consistency
• Monitor process data and review methods, facilities and equipment design to ensure operational and process consistency
• Support quality investigations and technology transfer initiatives as a subject matter expert
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output
• Ensure that operations are performed in a manner consistent with safety standards and within cGMP guidelines
• Assist in the design review of equipment and facilities
• Support process transfers to internal and external facilities
• Assist in the assessment of manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities
• Lead investigations and initiatives
• Identify, assess, and lead implementation of new technologies and processes
• Communicate effectively with cross‑functional teams
• Expand interdepartmental relationships

Requirements

• BS in Engineering; chemical engineering or biomedical engineering preferred; or equivalent combination of education & experience
• Principal Manufacturing Process Engineer: 8+ years of experience; Staff Manufacturing Process Engineer: 10+ years of experience; level determined based on experience
• Ability to work in full cleanroom attire (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, use of sanitizing agents including IPA) and to remove jewelry, make‑up, and nail adornments when wearing cleanroom attire