Calibration Technician IV

Summary : The Calibration Technician IV 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.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

Job Description

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.
• Prepare SOP’s for calibration of instrumentation and laboratory equipment.
• Perform investigations and initiation of any documentation resulting from ‘out of tolerance’ conditions with respect to instrumentation and calibration standards.
• Serve in a lead role position for Calibration Group members or Contractors supporting similar functions, as required.
• Serve as a CCMS System Administrator, as needed.
• Process Blue Mountain (CCMS) calibration work requests, change requests, asset inductions, asset creation, MDT creation and calibration event creation and equipment scheduling.
• Perform duties involved in off-site vendor calibrations: Procure quotes, initiate purchase requisitions, ship to vendors, receive back from service, review and approve the vendor documents and complete the work orders.
• Perform duties involved in on-site vendor calibrations: Procure quotes, initiate purchase requisitions, schedule work, escort vendors, review and approve the vendor documents and complete the work orders.
• 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.
• Review/approve completed calibration records for accuracy and completeness, as required.
• Serve as an SME to assist the Calibration Supervisor, Manager and Quality teams to resolve deviations and track closures of any associated corrective actions.
• Provide training to lower level Calibration Group members or Contractors.
• Complete calibration work orders and engineering change controls within the allotted time.
• 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.
• Support adherence to compliance with 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, contractors, 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 of complex Manufacturing, Utility, Quality Control, Process Development and analytical equipment instrumentation and systems.
• Strong written, verbal and interpersonal communications skills.
• Ability to work quickly and effectively with minimal 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 Instrumentation, Electrical Engineering, or other related discipline with a minimum of 5 years in calibrations activities experience in a cGMP or other FDA regulated operation; OR
• Associates degree in Instrumentation or other related discipline with a minimum of 5 years of overall experience in calibration activities 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 in a cGMP or other FDA regulated operation or a bio-tech facility.
  
  

Preferred Qualifications:

• Experience working in a biotechnology facility.
  
  

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.

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 (FDBTHR@fujifilm.com or (979) 431-3500).