Calibration Technician III

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Job description

Join the BioPharma Consulting JAD Group team as a Calibration Technician III! In this role, you will be responsible for performing calibration and maintenance activities on various process equipment and instrumentation to ensure accurate and reliable measurements in compliance with regulatory requirements. 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. You will work closely with manufacturing, engineering, and quality teams to support our operations and maintain the highest standards of quality and compliance.
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.

Requirements

Education and Experience:

Bachelor's degree in a related discipline with a minimum of 3 years in calibrations activities experience OR

Associates degree in a related discipline with a minimum of 5 years of overall experience in calibration activities OR

High School Diploma or equivalent military training with a minimum of 7 years in overall calibration activities

Skills and Qualifications:

Strong knowledge of calibration principles and techniques.

Experience with calibration software and tools.

Familiarity with regulatory requirements such as FDA, ISO, and GMP.

Ability to read and understand engineering drawings, schematics, and technical specifications.

Excellent attention to detail and documentation skills.

Strong problem-solving and troubleshooting abilities.

Good communication and interpersonal skills.

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