Metrology Manager

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin, TX is seeking a Metrology Manager to lead calibration and maintenance for the facility, ensuring instruments meet specifications and regulatory standards. You will oversee a calibration staff, develop documentation, and drive continuous improvement in metrology practices.

The role involves coordinating with auditors and internal teams, troubleshooting instrumentation issues, and establishing performance metrics.

Qualifications

• Must have a bachelor’s degree in Engineering or related discipline or equivalent experience in professional metrology.
• Minimum 8 years in a leadership role within a cGMP environment, with operations or engineering focus.
• Experience in calibration supervision or metrology management in regulated settings preferred.

Responsibilities

• Promotes safe work practices and maintains a safe environment.
• Administers calibration program to support batch release and validation testing.
• Hire, develop and supervise staff; conduct performance reviews and related activities.
• Maintain calibration records and procedures to meet regulatory compliance.
• Interface with FDA and auditors as a technical calibration expert.
• Troubleshoot instrumentation and related systems; address issues impacting operations.
• Select and configure instrumentation and equipment for projects and improvements.
• Establish and maintain metrics to meet departmental objectives.

Skills

Strong communication

Problem solving

Leadership

Time management

Education

Bachelor’s degree in Engineering or related field

Equivalent metrology leadership experience

Job description

Position Summary

The Metrology Manager is responsible for establishing and executing a program of instrument calibration and maintenance for the Austin facility through the management of a calibration staff. Ensures all instruments meet current specifications and are properly calibrated. Generates and maintains calibration and preventative maintenance documentation for regulatory review. Ensures all departmental procedures meet corporate requirements. Provides troubleshooting and repair services of instruments.

Essential Duties & Responsibilities

• Promotes safe work practices and ensures a safe work environment by adherence to all plant safety rules in areas of responsibility.
• Administration of the calibration program ensuring scheduled and demand calibration’s supporting batch release and validation testing are completed in a timely manner; reviewing and approving changes to instrument records and procedures; and reporting basic performance metrics.
• Hire, develop, and supervise staff through personnel selection and development. Perform performance reviews, disciplinary actions, and other activities inherent to a manager role.
• Maintain instrumentation/calibration/maintenance records and procedures in a manner that meets regulatory compliance. Completes assigned investigations, exception reports and corrective actions and preventive actions in a timely manner.
• Interfaces with FDA and other external and internal auditors as a technical expert for instrument calibration.
• Ensures a rapid response to address instrumentation/calibration related issues impacting operations. Responsible for troubleshooting instrumentation and related systems.
• Selection and configuration of instrumentation, controls and related equipment to support new projects and continuous improvement efforts.
• Establishes and maintains metrics to meet departmental objectives.

Knowledge & Skills

• Requires excellent communication and interpersonal skills. Requires the ability to work with people and effectively communicate instructions and ideas clearly.
• Requires excellent problem-solving skills. The ability to analyze situations and find effective solutions to problems.
• Requires the ability to effectively time manage and be organized. High paced environment with multiple tasks, which requires the ability to self-prioritize tasks well.
• Requires effective Leadership skills. Requires the ability to manage work primarily with supervisors. Must have the ability to motivate them and lead out on important initiatives.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor’s degree in Engineering or related discipline and/or equivalent experience in Professional Metrology Role.
• Minimum 8 of years of experience required in a leadership role,within cGMP environment, five of which is in a leadership function within Operations or Engineering environment.
• Minimum combination of eight years’ experience in one or more of the following areas: Calibration Supervisor, Controls Engineer, Metrology Manager, Process or Controls Engineering Manager. Experience in a regulated industry or Military performing similar function preferred.

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Requires routine follow up on heavy industrial manufacturing floor.
• May require routine follow ups in a clean room environment.
• Typically requires travel less than 5% of the time