Senior Coordinator, Calibration

About the Role

The Sr. Calibration Coordinator assists the Calibration team to ensure cGMP compliance and on‑time calibration work performed at Fujifilm Diosynth Biotechnology Texas (FDBT) facilities in College Station, Texas. This individual will assist in implementing and scheduling the calibration of instruments and devices in the facility with an emphasis on planning and scheduling calibration. The role may also involve preparing SOPs and calibration instructions for new systems, scheduling periodic calibration, and documenting instruments that fail calibration or are retired.

Company Overview

Fujifilm Biotechnologies Texas develops vaccines and advances cell and gene therapies, collaborating with industry leaders to tackle complex challenges. The state‑of‑the‑art biomanufacturing facility in College Station offers a flexible work environment and a culture that fuels passion, energy, and drive—what Fujifilm calls “Genki.” The company is globally headquartered in Tokyo with over 70,000 employees across healthcare, electronics, business innovation, and imaging.

Essential Functions

• Oversee and manage on‑site and off‑site calibrations for all production, laboratory, and test equipment to ensure proper functioning and compliance with SOPs.
• Develop, implement, and manage a calibration schedule to ensure all calibrations are completed within the required time frame, minimizing equipment downtime.
• Maintain continuous communication with the Calibration Planner to ensure the schedule is met.
• Attend various planning and scheduling meetings for the site.
• Coordinate, lead, and supervise day‑to‑day calibration activities for on‑site and off‑site calibrations.
• Ensure technicians and contractors follow procedures and safety requirements.
• Lead Calibration Coordinator to support Manufacturing and Projects.
• Support new product introductions.
• Conduct investigations and initiate documentation for “out of tolerance” conditions.
• Serve as a CCMS System Administrator, as needed.
• Process Blue Mountain (CCMS) calibration work requests and change requests.
• Perform off‑site vendor calibration duties: procure quotes, initiate purchase requisitions, ship to vendors, receive service, review vendor documents, and complete work orders.
• Assist the Calibration Supervisor, Manager, subject‑matter experts, and quality teams to resolve deviations and track corrective actions.
• May assist with authoring, reviewing, and approving SOPs and Work Instructions for original and periodic updates.
• Review/approve completed calibration records for accuracy and completeness, as needed.
• Maintain inventory of consumable standards, MSDS sheets, and calibration supplies.
• Archive hard‑copy calibration certificates for record retention.

Required Skills & Abilities

• General knowledge of calibration procedures and techniques.
• Strong planning skills and willingness to interface with and support team members across many roles and functions.
• Excellent oral and written communication, interpersonal, and organizational skills.
• Proficiency with Microsoft Office applications.
• Good self‑discipline and attention to detail.
• Ability to work quickly and effectively.
• Analytical and problem‑solving skills with experience applying them to resolve technical problems.
• Flexibility to work outside normal hours, including alternative shifts and weekends as required.
• Ability to work with a CCMS system.
• Understanding of calibration documentation requirements for a cGMP facility.

Working Conditions & Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged sitting, standing, walking, bending, stooping, and stretching.
• Hand‑eye coordination and manual dexterity to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Occasional lifting of up to 50 pounds.
• Climbing ladders and stairs of various heights.
• Exposure to wet or humid conditions.
• Exposure to outdoor weather conditions.
• Exposure to noisy environments.
• Mandatory attendance.

Minimum Qualifications

• Bachelor’s degree with a minimum of two (2) years of experience in calibration activities planning/scheduling; OR
• Associate’s degree with a minimum of three (3) years of experience in planning/scheduling; OR
• High School Diploma or equivalent military training with a minimum of five (5) years of experience in planning/scheduling.

Preferred Qualifications

• Experience with calibration procedures and methods.
• Experience working with CCMS programs such as Blue Mountain RAM.
• Experience in a cGMP‑regulated industry.
• Experience with different calibration standards (e.g., ISO 9001, ISO/IEC 17025, FDA) and relevant regulatory requirements.