FUJIFILM Diosynth Biotechnologies Texas, LLC Calibration Technician - Group Lead in Texas

Summary: Calibration Technician Group Lead will support the cGMP Calibration Program at the Fujifilm Diosynth Biotechnology facilities in College Station Texas. The Group Lead may also assist in providing support at the research and production facilities (Buildings TBF 100/FBF 200) as directed by the Calibration Manager. The Group Lead will initiate, implement, and schedule the calibration of instruments and devices in the NCTM facility through the use of calibration technicians, other technicians, and outside resources and vendors.

This position supports the Calibration Manager in these functions with supervision as required. The Group Lead should be able to perform a wide variety of instrument calibrations both new and in use, through following of cGMP instructions, calibration standards and making instrument adjustments where required. This also requires recording detailed and accurate calibration information. The Group Lead should be able to enter new instruments into the system, identify failures of instruments, and prepare formatted failure reports and deviations as needed. The instruments and devices may range from standard utility gages to complex temperature, pressure, time, flow, and other measuring devices on 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, Remote Monitoring Systems, and a variety of analytical and test equipment.

Essential Functions:

  • This position will perform hands on calibrations per cGMP procedures and document the calibration either on paper or through the use of a Computer Based Management System (CMMS).
  • Oversee the calibration services provided by vendors and/or contractors at the NCTM facility and assist the Calibration Manager in overseeing contractors, technicians, and/or vendors in Buildings TBF 100/FBF 200 as needed. This position should be able to identify gaps, if any, between outside calibration services and the need of our internal processes.
  • Provide calibration advice/training to internal customers, as necessary, on their calibration needs, and instruction if needed for operator performed calibrations, such as PH meters, care and use of check weights, proper maintenance of calibration standards/solutions, etc.
  • Assist Calibration Supervisor in vendor selection, vendor qualification, and service contract negotiations.
  • Responsible for the installation, calibration, and document control and relevant quality standards on site.
  • Responsible for installation and commissioning service on new equipment and modification of existing equipment.
  • Communicate regularly with laboratory and manufacturing supervisors and managers regarding upcoming needs of their areas and the need for timely completion of existing calibration requirements at the NCTM facility.
  • Assist the Calibration Manager and communicate regularly with laboratory and manufacturing supervisors and managers regarding the calibration requirements of new equipment as it enters the system.
  • Prepare reports, analyzing data, and making recommendations for improving the NCTM facility Calibration program.
  • Prepares deviation reports as necessary, for instruments when calibration indicates failure or out of tolerance conditions.
  • Develop, update, and/or review Calibration and Metrology SOP's for the NCTM facility; assist the Calibration Manager in maintaining and updating Calibration and Metrology SOPs and other Procedures for Buildings TBF 100/FBF 200.
  • Monitors the use and inventories of spare parts and calibration supplies; prepares documentation / justifications and obtains approval to replenish inventory to the Calibration Manager.

Required Skills & Abilities:

  • Strong experience with 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 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. Must be good with numbers and data with few mistakes.
  • Ability to work in a fast paced environment.
  • Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint). Strong knowledge and ability in Excel or one of several CMMS Database systems, such as Blue Mountain.
  • Strong knowledge and demonstrated experience in calibration and documentation requirements for cGMP manufacturing.
  • Demonstrated ability to maintain accurate data, accuracy with numbers, ability to identify abnormal data in data-sets.

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 with three (3) years overall experience with calibration activities in a calibration or metrology laboratory in a cGMP environment or other FDA or USDA regulated facility required; OR
  • Associates Degree with seven (7) years overall experience with calibration activities in a calibration or metrology laboratory in a cGMP environment or other FDA or USDA regulated facility required.

Preferred Qualifications:

  • Experience working in a biotechnology facility.

Job Start/End Date: 17-May-2017 to 05-Oct-2017 (CST)

Department: Facilities

Location: TX, USA

Employment Type: Full Time