Calibration Engineer / Metrologist

Employer
FISI FUJIFILM Irvine Scientific
Location
Santa Ana, CA
Posted
Sep 14, 2021
Closes
Sep 16, 2021
Ref
2458013566
Organization Type
Corporate
Overview
FUJIFILM Irvine Scientific, Inc., is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.

We are hiring Calibration Engineer/Metrologist. The Calibration Engineer will be responsible for making sure FISI equipment, instruments and testing devices are calibrated correctly and give accurate readings in line with Vendors' standards. This employee will be expected to perform this role meticulously, as improper calibration can cause issues concerning safety, wastage, and faulty quality of products. Therefore, being able to provide the guidelines and strategical calibration approaches and pay attention to detail is vital, as well as problem-solving skills and ability to work well and effectively with others.

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External US
Responsibilities:
  • Serve as calibration administrator on instrument calibration tracking software
  • Function as administrator of Environmental Monitoring System
  • Ensure environmental monitoring probes are located at the correct locations
  • Write Calibration and Environmental Monitoring SOPs
  • Comply with internal customer requests; establish Instrument Master Form (Calibration Requirements) with internal customers
  • Organize calibration service schedules with internal customers and vendors; ensure proper communication with internal customers
  • Write Out of Specification (OOS) and Non-Compliance Reports (NCR)
  • Calibrate in multiple parameters in line with equipment use
  • Work to ISO 9001: 2015 & 17025: 2017 standard
  • Carry out quality inspections on vendors
  • Assist installation and operational qualification activities upon request

Experience/ Education:
  • B.S. or H.S. Diploma with trade school and/or formal training on equipment and instrument calibration
  • 10+ years' work experience in general facility, production, R&D and QC equipment and instrument qualification and calibration
  • Experience with Computerized Calibration System, such as BMRAM and REES
  • Proficiency in Windows including Outlook, Excel and Word
  • Understand thermal mapping and environmental monitoring
  • Ability to read, interpret, and work from electrical, mechanical diagrams and equipment manuals
  • Ability to work independently with no supervision
  • Must understand calibration requirements on ISO 17025
  • Experience working in GMP environment; previous experiences in Pharmaceutical, Medical Devices and Biotechnology industries are pluses
  • Understand mechanical and electrical systems
  • Working knowledge of cGMP and ISO 17025

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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