Metrology Specialist II; Calibration

The Calibration Metrologist ensures the accuracy, reliability, and traceability of measurement and test equipment (M&TE) in compliance with FDA, GMP, ISO 13485, and ISO/IEC 17025 requirements. This role is responsible for performing, documenting, and coordinating calibration and maintenance activities to support manufacturing, quality control, and laboratory operations within pharmaceutical and medical device environments.

• Associate or Bachelor’s degree in Metrology, Engineering, Physics, or equivalent experience
• 3 plus years of calibration and metrology experience within pharmaceutical, medical device, and regulated manufacturing environments (Cleanroom Environment).
• Skilled in performing calibration, verification, and maintenance of mechanical, electrical, thermal, and dimensional equipment using standards traceable to NIST.
• ASQ, NCSL International, NIST or any equivalent Metrology Certification is a plus

• Perform routine and non-routine calibration, verification, and maintenance of measurement and test equipment (balances, pressure gauges, temperature sensors, dimensional tools, pH meters, and other analytical instruments).
• Utilize standards traceable to NIST or equivalent; conduct in-house and coordinate external vendor calibrations.
• Interpret calibration data, address measurement deviations, and implement corrective actions.
• Maintain calibration records and ensure compliance with GMP, 21 CFR, ISO 13485, USP, IEC, and approved SOPs.
• Support audits, impact assessments for out-of-tolerance findings, and deviation/CAPA investigations.
• Develop and update calibration procedures and SOPs; assist with equipment validation and qualification.
• Provide technical guidance to production, QC, and engineering teams on measurement best practices.
• Drive continuous improvement initiatives for metrology systems and equipment control.