Turesol, the staffing division of Tunnell Consulting, looks for top talent on behalf of our Pharmaceutical/Biotech clients. Currently, one of our client’s needs Calibrations Technician Level II. This is a permanent position.
Title: Calibrations Technician Level II
Summary: The Calibration Technician Level II is responsible for maintaining and improving the cGMP Calibration Programs. 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.
- Perform calibrations of complex instrumentation on production, laboratory and facility systems ensuring all systems and devices are calibrated in accordance with manufacturer’s specifications and Client’s SOP’s.
- Assist in the development of investigations resulting from ‘out of tolerance’ conditions with respect to instrumentation.
- Share knowledge and experiences with other Calibration Technicians.
- Timely completion of all calibration work orders and engineering change controls.
- Assist in interfacing with calibration contractors ensuring work is compliant with Client’s SOP’s and GMP’s to maintain state of the art technology within the facility.
- Assist in maintaining all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with GMP’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.
- 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.
- Good analytical and problem-solving skills and experience applying these skills to resolve technical problems.
- Ability to work with CMMS System.
- Ability to work in PLC, Delta V, and SCADA Systems.
- Knowledge of calibration and documentation requirements for GMP manufacturing.
Required Experience and Education:
- Bachelor’s degree in Engineering or Scientific Discipline with a minimum of 2 years in calibrations activities experience of which at least 1 year must be in a GMP or other FDA regulated operation; OR
- Associates degree in Engineering or Science with a minimum of 3 years of overall experience in calibration activities of which at least 1 year must be in a GMP or other FDA regulated operation; OR
- High School Diploma or equivalent military training with a minimum of 5 years in overall calibration activities of which at least 3 years must be in a GMP or other FDA regulated operation or a bio-tech facility.
- Experience working in a biotechnology facility.