FUJIFILM

Calibration Technician III

Job Locations US-TX-College Station
Posted Date 2 weeks ago(6/18/2024 12:30 PM)
Requisition ID
2024-27335
Category
Facilites
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FDB call Genki. 

 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

 

Summary:  The Calibration Technician III is responsible for maintaining and improving the cGMP Calibration Programs at the Fujifilm Diosynth Biotechnology Texas (FDBT) facilities in College Station Texas. 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 for the new Texas Bio-Manufacturing Facility as well as maintaining the current operation of the existing facility.

External US

Essential Functions:

  • Perform troubleshooting and calibration of complex instrumentation on production, laboratory and facility systems ensuring all systems and devices are calibrated in accordance with manufacturer’s specifications and FBDT SOP’s.
  • Assist in preparing SOPs for calibration of instrumentation and laboratory equipment.
  • Assist in the development of investigations and initiation of any documentation resulting from ‘out of tolerance’ conditions with respect to instrumentation.
  • Share knowledge and experiences with lower level Calibration Technicians.
  • Complete calibration work orders and engineering change controls within the allotted time.
  • Interface with calibration contractors ensuring work is compliant with FBDT SOP’s and cGMP’s to maintain state of the art technology within the facility.
  • Maintain all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP’s by the utilization of the site CMMS and Document Management Systems.
  • Ensure compliance with all applicable regulatory agencies including FDA, OSHA, EPA, etc.
  • Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.
  • Work with project managers, technical services or equipment owners in order to perform assigned special projects.
  • All other duties as assigned.

 

Required Skills & Abilities:

  • Strong knowledge of calibration procedures and techniques, including calibration of thermometers, PH meters, pressure and vacuum gages, differential pressure gages, autoclaves, CIP/SIP systems, incubators, analytical equipment, and process tanks as well as other laboratory instruments. This will include equipment instrumentation and instruments installed in Loops.
  • 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.​
  • Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).
  • Demonstrated ability to work with CMMS System.
  • Demonstrated ability to work in PLC, Delta V, and SCADA Systems.
  • In-depth knowledge of calibration and documentation requirements for cGMP manufacturing.
  • Experience in Start-Up & Commissioning of cGMP Facility.

 

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 70 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 in a related discipline with a minimum of 3 years in calibrations activities experience of which at least 2 years must be in a cGMP or other FDA regulated operation; OR
  • Associates degree in a related discipline with a minimum of 5 years of overall experience in calibration activities of which at least 4 years must be in a cGMP or other FDA regulated operation; OR
  • High School Diploma or equivalent military training with a minimum of 7 years in overall calibration activities of which at least 6 years must be in a cGMP or other FDA regulated operation or a bio-tech facility.

 

Preferred Qualifications:

  • Experience working in a biotechnology facility.

 

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.

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 979-431-3500.

 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

 

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