Sr Manager, Calibration

Position Overview

TheSr.CalibrationManageris responsible for the oversight of thecGMPMetrology andCalibration Programsat the Fujifilm Diosynth Biotechnology facilities in College Station Texas, includingtheresearch andallproduction facilities.TheManageris responsible for theinitiation, implementation, andon time completion of theinstruments’calibrationand devices in thefacilityusingtechnicians and\oroutside resources and vendors.TheManager is responsible for ensuring that allSOPs andcalibrationinstructions for new instrumentsare prepared andenteredintothe system; thatthe periodic calibration of those instrumentsduring their life cycleis completed timely and efficiently;and the proper documentationofwhen those instruments and devicesmay either fail calibration or be retired from the systemare 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 systemsand a variety of analytical and test equipment.This is a key position in the readiness of the instrumentation and equipment to enable thecompany to meet the expectations of our clients.This position will work closely withEnvironmentalHealth and Safety (EHS) to develop and ensure a safeworkplaceis maintained, with Planning group for thealignmentof activities and scheduling calibrations within approved windows providedbyOperationsand Maintenance group to support troubleshooting and plant readiness.

Company Overview

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Essential Functions:

• Direct, execute, and verify calibration activities performed by FDBT personnel and contractors, including formal review and inspection of completed work.

• Responsible forthe 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 fordevelopinginstrumentation end of lifestrategy and replacementbudget.

• Perform formal and on-the-job training and instruction ofpersonnel involved incalibrationin other departmentsregarding propercalibration procedures, use of standards, and recordkeeping.

• Communicate regularly withlaboratory and manufacturing supervisors and managers regarding the upcoming needs of their areas and the need for timely completion ofexistingcalibration requirements.

• Communicate regularly with laboratory and manufacturing supervisors and managersregarding the calibration requirements of new equipment as it enters the system.

• Communicateeffectivelywithmaintenance,planning and scheduling and other support groupsregardingthecalibrationschedule of the facilities.

• Preparesreports, analyze data, makesrecommendations, and/or presentations to management on improvementswith regards to thecalibration program.

• Responsible for theplanning and implementingproper calibration needs duringfacility improvements and expansions.

• Responsible for the preparation and closure ofdeviation reports for instruments when calibration indicates failure or out of tolerance conditions.

• Responsible formaintaining and updatingCalibration and Metrology SOPs and otherproceduresfor theFacilitiesdepartment.

• Responsiblefor themanagement ofinternal metrology capabilities and external calibration labsincluding any vendor or service provider qualification; maintainsvendor SLAs, performance dashboards, and audit readiness.

• Monitors the useand inventories of spare parts and calibration supplies under the responsibility of thecalibration role.Ensurethat supplies are ordered timely in acost-efficientmanner.

• Responsible to support equipmentIQ/OQ/PQ or any other validation startup activity as required.

• Develop, implement, maintain, and monitor departmental KPIs to ensure a high level of efficiency.

• Communicate easily with Contractors, Validation, Quality Assurance, Operations, Engineers, OEM providers, as well as internal equipment owners and operators, for successful management of theMetrology andCalibrationdepartment in FLBT.

• All other duties as may be assigned.

Required Skills & Abilities:

• Proficientknowledge ofmetrology andcalibration proceduresand techniques, including calibration of thermometers, PHand conductivitymeters,pressure and vacuum gages, differential air pressure gages, as well as otherprocess andlaboratory instruments.

• Excellentwritten, verbal and interpersonalcommunicationsskills.

• Demonstrated ability to work quickly and effectively without supervision.

• Strong analytical andproblem-solvingskills and experience applying these skills to resolve technical problems.

• Demonstrated ability to work in afast-pacedenvironment.

• Strong working knowledge of MS Officeproducts(Word, Excel, Outlook,PowerPoint)and calibration management systems (e.g., Blue Mountain, etc.).

• In-depth knowledge ofmetrology,calibration, instrumentationand documentation requirements for cGMP manufacturing.

• Demonstratedworkingexperiencein a biotechnology facility.

• Knowledge of Calibration system and program using a CCMS/CMMS required.

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 toenable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching.

• Utilize hand-eye coordination and manual dexterity to operate portable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment.

• Regularly lift and move objects weighing up to 50 pounds.

• Climb ladders and stairs of varying heights.

• Work under conditions that may be wet or humid.

• Provide support during off shifts, weekends, and holidays as needed.

• This position will include On-Call response forissues

• Work in outdoor weather conditions and noisy environments.

• Offer 24/7 support for company activities.

• Maintain mandatory attendance.

Minimum Qualifications:

• Bachelor’sdegreepreferably in Engineering/Instrumentation/ Automationor relateddisciplinewithat leasteight (8) years of qualifyingexperiencein acalibration or metrology laboratory inaFDAregulatedcGMP environment orequivalentregulatoryframework.

• Associate’s degreepreferablyin Engineering / Instrumentation / Automation or relateddisciplinewithat leastten(10) yearsof qualifyingexperience in a calibration or metrology laboratory inaFDA regulatedcGMP environment orequivalentregulatoryframework.

• A minimum of five (5) years of previous leadership experience.

Preferred Qualifications:

• Knowledge of Blue Mountain Regulatory Asset Manager CCMS/CMMS.

• Knowledge ofTrackwisequality management software.

• Knowledge of bio-processing equipment, and single use technology.

• Experience with development of technician training / qualification program.

• A wide range of maintenance and trade experience is a plus, including mechanical/electrical systems,controlsand PLC operations.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected] or (979) 431-3500).

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Job Locations US-TX-College Station

Posted Date (9/8/2026 8:09 AM)

Requisition ID 2026-38756

Category Facilities

Company (Portal Searching) FUJIFILM Biotechnologies