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 and\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.

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 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 effectively with maintenance, planning and scheduling and other support groups regarding the calibration schedule of the facilities.

• Prepares reports, analyze data, makes recommendations, and/or presentations to management on improvements with regards to the calibration program.

• Responsible for the planning and implementing proper calibration needs during facility improvements and expansions.

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

• Responsible for maintaining and updating Calibration and Metrology SOPs and other procedures for the Facilities department.

• Responsible for the management of internal metrology capabilities and external calibration labs including any vendor or service provider qualification; maintains vendor SLAs, performance dashboards, and audit readiness.

• Monitors the use and inventories of spare parts and calibration supplies under the responsibility of the calibration role. Ensure that supplies are ordered timely in a cost-efficient manner.

• Responsible to support equipment IQ/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 the Metrology and Calibration department in FLBT.

• All other duties as may be assigned.

Required Skills & Abilities:

• Proficient knowledge of metrology and calibration procedures and techniques, including calibration of thermometers, PH and conductivity meters, pressure and vacuum gages, differential air pressure gages, as well as other process and laboratory instruments.

• Excellent written, verbal and interpersonal communications skills.

• Demonstrated ability to work quickly and effectively without supervision.

• Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems.

• Demonstrated ability to work in a fast-paced environment.

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

• In-depth knowledge of metrology, calibration, instrumentation and documentation requirements for cGMP manufacturing.

• Demonstrated working experience in 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 to enable 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 for issues

• Work in outdoor weather conditions and noisy environments.

• Offer 24/7 support for company activities.

• Maintain mandatory attendance.

Minimum Qualifications:

• Bachelor's degree preferably in Engineering / Instrumentation / Automation or related discipline with at least eight (8) years of qualifying experience in a calibration or metrology laboratory in a FDA regulated cGMP environment or equivalent regulatory framework.

• Associate's degree preferably in Engineering / Instrumentation / Automation or related discipline with at least ten (10) years of qualifying experience in a calibration or metrology laboratory in a FDA regulated cGMP environment or equivalent regulatory framework.

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

Preferred Qualifications:

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

• Knowledge of Trackwise quality 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, controls and PLC operations.