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Manufacturing Engineer

Employer
FISI FUJIFILM Irvine Scientific
Location
Santa Ana, CA
Closing date
Sep 21, 2021

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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 a Manufacturing Engineer. The Manufacturing Engineer is responsible for assigned engineering related projects in the design, construction, implementation, maintenance and improvement of manufacturing processes in liquid & powder media, diagnostic kits, and biological products manufactured by FUJIFILM Irvine Scientific.

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External US
Responsibilities:
  • Make recommendations for the improvement of any procedures or processes that will result in better efficiency, cost reduction and/or improved product quality
  • Research and recommend new equipment and/or manufacturing processes
  • Utilize FUJIFILM Irvine Scientific design control procedures for implementation of projects and processes or improvements to product or processes
  • Prepare and approve protocols and reports related to design control activities
  • Propose, write, and review departmental standard operating procedures (SOP's)
  • Assist Manufacturing with production floor issues related to the manufacturing process, including research into customer complaints

Experience/ Education:
  • Bachelor's degree in Mechanical/Industrial Engineering, Biology, or Chemistry
  • Three years in an R&D or Manufacturing support engineering role preferably in the Pharmaceutical, Medical Device, or Biological industry
  • Familiarity with GMPs, ISO
  • Ability to read a blueprint
  • Project Management experience
  • Design Control experience

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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