Metrology Manager Otsuka ICU Medical LLC Austin, TX Job Details Full-time 18 hours ago Qualifications GMP Manufacturing facility experience Manufacturing Team motivation (leadership skill) Pharmaceutical manufacturing facility experience Full 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 Innovation, Impact, and Purpose. Find Your Future Here. We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption. When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide. We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters. Join us and help shape the future of IV solutions.

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