Metrology Manager

Role Summary

The Metrology Manager is responsible for developing and leading Denali’s site-wide metrology and calibration program to support GMP manufacturing, utilities, and laboratories. This leadership role ensures that all critical instruments and equipment are calibrated, traceable, and maintained in compliance with FDA, EMA, and ISO regulations. The role requires building systems, processes, and a culture of excellence and reliability, with a strong technical foundation in instrumentation and calibration and experience managing people and programs in a GMP environment.

Responsibilities

• Metrology Program Development: Establish and lead the site’s calibration program, align with Quality Systems and GMP standards; develop calibration and preventive maintenance schedules, methods, and documentation for accuracy and compliance.
• Oversee internal and external calibration service providers, ensuring adherence to procedures and timelines.
• Maintain the site’s calibration maintenance management system (CMMS) for complete traceability and data integrity.
• Compliance & Quality: Ensure all calibration activities comply with regulatory standards; support internal and external audits; investigate out-of-tolerance conditions and drive CAPA implementation; collaborate with QA and Validation on change control, risk assessments, and qualification activities.
• Leadership & Team Management: Supervise and mentor calibration technicians and/or engineers; develop training plans; build a high-performance culture focused on safety, accountability, and continuous improvement; manage direct reports’ annual goals and training compliance.
• Cross-Functional Support: Partner with Facilities, Engineering, Manufacturing, and Quality to ensure equipment readiness and reliability; provide metrology expertise for new equipment installations, commissioning, and qualification (IQ/OQ/PQ); participate in process improvement initiatives and investigations.

Qualifications

• Bachelor’s degree in Engineering, Instrumentation, Metrology, or a related technical field.
• Significant calibration or instrumentation experience in a GMP-regulated biopharmaceutical or medical device environment.
• 3+ years in a leadership or supervisory capacity.
• Experience implementing and maintaining calibration programs during site startup or facility expansion is preferred.
• Strong understanding of calibration standards, instrumentation principles, and metrology best practices.
• Experience with computerized calibration management systems (e.g., Blue Mountain, ProCal, Maximo).
• Familiarity with bioprocess equipment (bioreactors, temperature-controlled units, CIP/SIP systems, autoclaves, utility systems).
• Knowledge of regulatory standards and audit expectations.

Skills

• Strong communication and organizational skills.
• Problem-solving abilities and attention to detail.
• Ability to lead in a fast-paced, startup-like environment and drive continuous improvement.

Education

• Bachelor’s degree in Engineering, Instrumentation, Metrology, or related field.

Additional Requirements

• Role is on-site at Denali’s Salt Lake City GMP Manufacturing Facility.
• May require off-hours or weekend work to support production and qualification schedules.