- 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.
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.
- 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.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.