Senior Coordinator, Calibration

Fujifilm•College Station, TX

13d•Onsite

About The Position

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. This individual may also assist in preparing SOPs and calibration instructions for the new systems entering the system, scheduling the periodic calibration of those instruments and the proper documentation when those instruments and devices may either fail calibration or be retired from the system. The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”

Requirements

A good general knowledge of calibration procedures and techniques.
Must have good planning skills and willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities.
Strong oral and written communication skills, interpersonal and organizational skills.
Proficient with Microsoft Office applications.
Good self-discipline and attention to detail.
Ability to work quickly and effectively.
Good analytical and problem-solving skills and experience applying these skills to resolve technical problems.
Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift hours and weekends as required.
Ability to work with a CCMS system.
Understand calibration documentation requirements for cGMP facility.

Nice To Haves

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.

Responsibilities

Oversee and manage the on-site and off-site calibrations for all production, laboratory, and test equipment to ensure proper functioning and compliance with various standard operating procedures (SOPs).
Develop, implement, and manage a calibration schedule to ensure all on-site and off-site calibrations are completed within the required time frame, minimizing equipment downtime.
Maintain continuous communication with the Calibration Planner to ensure the established calibration 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 that technicians and contractors follow procedures and safety requirements to perform the work.
Lead Calibration Coordinator to support Manufacturing and Projects. Support new product introductions.
Conduct investigations and initiate any documentation resulting from ‘out of tolerance’ conditions regarding on-site and off-site calibration.
Serve as a CCMS System Administrator, as needed.
Process Blue Mountain (CCMS) calibration work requests and change requests.
Perform duties involved in off-site vendor calibrations: Procure quotes, initiate purchase requisitions, ship to vendors, receive back from service, review the vendor documents and complete the work orders.
Assists the Calibration Supervisor, Manager or subject matter expert(s), and quality teams to resolve deviations and track closures of any associated corrective actions.
May assist the Supervisor/Manager with authoring, reviewing, and approving, SOPs and Work Instructions for both 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 as needed.
Archive hard copy calibration certificates for record retention.