Sr. Metrology Engineer

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

The Senior Metrology Engineer is responsible for providing technical leadership for the calibration, instrumentation, and metrology programs supporting the Wilmington greenfield biologics manufacturing site. This role owns the lifecycle management of critical instrumentation and calibration systems while establishing the site calibration program from the ground up. The position partners closely with Process Development, Manufacturing, Utilities, Automation, and Quality organizations to ensure instrumentation supports process capability, product quality, regulatory compliance, and operational excellence throughout the facility lifecycle.

• Provide metrology engineering leadership during design, construction, commissioning, qualification, startup, and commercial operation of site instrumentation and calibration programs.
• Develop and implement the site-wide calibration and metrology program for a greenfield biologics manufacturing facility aligned with our Company's standards and pharmaceutical industry best practices.
• Serve as the engineering owner for instrumentation and calibration systems supporting manufacturing, laboratories, process utilities, and facility infrastructure.
• Generate and maintain instrument datasheets, specifications, and technical standards for new and existing instrumentation assets.
• Support Process Development and Manufacturing organizations by establishing appropriate process measurement tolerances, instrument accuracy requirements, and critical process parameter monitoring strategies.
• Provide technical ownership for pressure, temperature, flow, conductivity, pH, level, humidity, differential pressure, analytical, and critical process instrumentation.
• Manage the full lifecycle of instrumentation assets, including selection, commissioning, qualification, calibration, maintenance, replacement, and obsolescence planning.
• Develop calibration procedures, tolerances, standards, and frequencies based on risk assessments, process requirements, and regulatory expectations.
• Support FAT, SAT, Commissioning, Qualification (CQV), and operational readiness activities for instrumentation systems.
• Establish vendor quality agreements and technical governance models for instrumentation and calibration service providers.
• Manage instrumentation and calibration vendors, including performance metrics, contract requirements, and service quality expectations.
• Lead troubleshooting efforts involving instrumentation failures, process deviations, and calibration-related investigations.
• Own and maintain engineering documentation including instrument specifications, loop drawings, calibration records, and asset hierarchies.
• Partner with Manufacturing, Utilities, Maintenance, Reliability, Automation, Validation, Quality Assurance, and EHSS organizations to ensure reliable and compliant operation of all calibrated assets.
• Drive continuous improvement initiatives focused on calibration optimization, digital metrology solutions, data integrity, and operational excellence.
• Maintain inspection readiness supporting FDA and regulatory inspections.
• Support future capital projects, instrumentation upgrades, and site expansion initiatives.

• Bachelor's degree in Engineering or a related technical discipline.
• 8+ years of metrology, calibration, or instrumentation engineering experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Strong expertise in process instrumentation, calibration programs, GMP utility systems, and process measurement technologies.
• Experience supporting greenfield projects, commissioning, startup, and operational readiness activities.
• Experience developing calibration programs and vendor management strategies.
• Excellent leadership, communication, and technical mentoring skills.

• Experience supporting biologics, sterile manufacturing, or vaccine facilities.
• Knowledge of GMP regulations, data integrity requirements, and ISPE guidance documents and industry calibration standards.
• Experience with Emerson DeltaV, Building Management Systems, utility instrumentation, and computerized calibration management platforms.
• Professional certifications related to metrology or calibration are preferred.
• Experience supporting process development and manufacturing scale-up activities.