What are the responsibilities and job description for the Calibration Technician III position at BioPharma Consulting JAD Group?
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.
Functions:
Qualifications:
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
- 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.
- Strong written, verbal and interpersonal communications skills
- Strong analytical and problem solving skills and experience applying these skills to resolve technical problems
- 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
- Experience in Start-Up & Commissioning of cGMP Facility
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
- Experience working in a biotechnology facility
