Sr Manager, Calibration

Position Overview

The Sr. Calibration Manager is responsible for the oversight of the cGMP Metrology and Calibration Programs at the Fujifilm Diosynth Biotechnology facilities in College Station Texas, including the research and all production facilities. The Manager is responsible for the initiation, implementation, and on time completion of the instruments' calibration and devices in the facility using technicians or outside resources and vendors.

The Manager is responsible for ensuring that all SOPs and calibration instructions for new instruments are prepared and entered into the system; that the periodic calibration of those instruments during their life cycle is completed timely and efficiently; and the proper documentation of when those instruments and devices may either fail calibration or be retired from the system are maintained.

This includes complex bio-pharma processing equipment such as Mobile Bio Processing Rooms, Mobile Clean Rooms, Bioreactors, Fermenters, centrifuges of various sizes and process, filtration skids, columns, critical water systems and a variety of analytical and test equipment. This is a key position in the readiness of the instrumentation and equipment to enable the company to meet the expectations of our clients.

This position will work closely with Environmental Health and Safety (EHS) to develop and ensure a safe workplace is maintained, with Planning group for the alignment of activities and scheduling calibrations within approved windows provided by Operations and Maintenance group to support troubleshooting and plant readiness.

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." Visit:

• Direct, execute, and verify calibration activities performed by FDBT personnel and contractors, including formal review and inspection of completed work.
• Responsible for the performance of contract calibration vendors and providers for continuing use of those providers or for selection of new providers, including preparation of bid packages and evaluation of new vendors.
• Define strategy, policies, procedures, and standards aligned with regulatory requirements (e.g., FDA cGMP, ISO/IEC 17025, ISO 9001).
• Ensure traceability to NIST/recognized NMIs; maintain robust, approved procedures and validated, Part 11-compliant calibration systems where applicable.
• Establish calibration intervals, tolerances, and as-found/as-left criteria; manage OOT/OOS, deviations, and CAPA with documented risk assessment and measurement uncertainty.
• Responsible for Calibration budget - setting annual budget as well as managing ongoing expenses.
• Responsible for developing capital expenditure budget and appropriate justifications for senior management review and approval. Also responsible for developing instrumentation end of life strategy and replacement budget.
• Perform formal and on-the-job training and instruction of personnel involved in calibration in other departments regarding proper calibration procedures, use of standards, and recordkeeping.
• Communicate regularly with laboratory and manufacturing supervisors and managers regarding the upcoming needs of their areas and the need for timely completion of existing calibration requirements.
• Communicate regularly with laboratory and manufacturing supervisors and managers regarding the calibration requirements of new equipment as it enters the system.
• Communicate…