Position Summary

The Project Engineer – Small Equipment Metrology is responsible for leading and supporting metrology-related engineering projects focused on small-scale equipment used across production, laboratories, and utilities. This includes ownership of calibration strategies, equipment lifecycle management, process improvement, and technical support to ensure compliance with cGMP, FDA, and other relevant standards.

The role requires a blend of engineering expertise, project management capability, and a strong understanding of calibration systems within a regulated biopharma environment.

Key Responsibilities

• Lead and execute metrology and calibration projects for small equipment across manufacturing, lab, and utility systems.
• Collaborate with operations, maintenance, and quality teams to ensure equipment calibration programs meet site and regulatory standards.
• Manage the lifecycle of small equipment assets, including specification, procurement, commissioning, and decommissioning.
• Develop and optimize calibration procedures, intervals, and data management within the CMMS/Metrology management system.
• Support audit readiness and respond to internal and external audit queries related to metrology activities.
• Implement continuous improvement projects to enhance calibration efficiency, accuracy, and traceability.
• Manage vendor relationships and support qualification of external calibration service providers.
• Generate and maintain technical documentation, including protocols, reports, and risk assessments.
• Ensure alignment of site metrology standards with Regeneron’s global engineering and compliance frameworks.

Required Qualifications & Experience

• Bachelor’s degree in Engineering (Mechanical, Electrical, Instrumentation, or related discipline).
• 3+ years of experience in metrology, instrumentation, or calibration engineering in a GMP-regulated or biopharmaceutical environment.
• Strong knowledge of calibration principles, measurement uncertainty, and equipment qualification.
• Experience using calibration or asset management systems (e.g., Blue Mountain, Maximo, or similar).
• Demonstrated ability to manage multiple projects in a fast-paced, highly regulated environment.
• Excellent technical writing, problem-solving, and communication skills.