Facilities - Calibration Supervisor

FDBT - FUJIFILM Diosynth
 Remote

Overview

Summary: The Calibration Supervisor oversees the cGMP Calibration Program at the Fujifilm Diosynth Biotechnology facilities in College Station Texas, including both research and production facilities. The Supervisor initiates, implements, and schedules the calibration of instruments and devices in the facility with an emphasis on planning and scheduling calibration through the use of technicians, and outside resources and vendors. The Supervisor prepares SOPs and calibration instructions for the new instruments entering the system, the periodic calibration of those instruments during their life cycle, and the proper documentation when those instruments and devices may either fail calibration, or be retired from the system. 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.

External US

Essential Functions:

  • This position will perform, review and inspect the work of personnel involved in calibration.
  • Evaluate the performance of contract calibration vendors and providers for continuing use of those providers or for selection of new providers.
  • 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 verbally and in writing with the Director of Facilities the calibration schedule of the facilities.
  • Prepare reports, analyze data, and make recommendations for improving facility operations with regards to the calibration program.
  • Assists with planning and implementing proper calibration needs during facility improvements and expansions.
  • Prepares deviation reports when required for instruments when calibration indicates failure or out of tolerance conditions.
  • Assist with maintaining and updating Calibration and Metrology SOPs and other procedures for the Facilities department.
  • Monitors the use and inventories of spare parts and calibration supplies under the responsibility of the calibration role.
  • Supervise and lead Calibration Technicians to support Manufacturing and Projects. Support new product introductions
  • Perform OOT and Deviation investigations for the Metrology group and Facilities Maintenance.
  • All other duties as may be assigned.

Required Skills & Abilities:

  • Strong knowledge of calibration procedures and techniques, including calibration of thermometers, PH meters, pressure and vacuum gages, differential air pressure gages, as well as other laboratory instruments. This will include equipment instrumentation and instruments installed in Loops.
  • Strong leadership skills including the
  • Strong written, verbal and interpersonal communications skills.
  • Ability to work quickly and effectively without constant supervision.
  • Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
  • Ability to work in a fast paced environment.​
  • Working knowledge of MS Office products (Word, Excel, Outlook, PowerPoint). Exceptional knowledge and ability in Excel highly preferred.
  • In-depth knowledge of calibration and documentation requirements for cGMP manufacturing.
  • Experience working in a biotechnology facility is preferred.

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:

  • Experience prolonged sitting, standing, walking, bending, stooping and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Have a normal range of vision.
  • The ability to regularly lift and/or move up to 45 pounds and occasionally lift and/or move up to 50 pounds briefly.
  • Climb ladders and stairs of various heights.
  • Be exposed to wet or humid conditions.
  • Be exposed to outdoor weather conditions.
  • Be exposed to noisy environments.
  • Attendance is mandatory.

Minimum Qualifications:

  • Bachelor’s Degree preferably in engineering or equipment automation or instrumentation with a minimum of five (5) years overall experience in calibration activities, of which a minimum of three (3) years in a calibration or metrology laboratory in a cGMP environment or other FDA or USDA regulated facility required; OR
  • Associates Degree preferably in engineering or equipment automation or instrumentation with a minimum of nine (9) years overall experience with calibration activities in a calibration or metrology laboratory in a cGMP environment or other FDA or USDA regulated facility required.
  • Must include 2 years supervisory experience

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.

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