Manufacturing Engineer

Manufacturing | Santa Ana, CA

Job Description:

We are hiring a Manufacturing Engineer. The Manufacturing Engineer will be responsible for serving as a technical representative for existing manufacturing processes and will be hands on solving issues during production and technology transfer. The Manufacturing Engineer will also be responsible for the support and optimization of manufacturing processes in liquid & powder media, diagnostic kits, and biological products manufactured by FUJIFILM Irvine Scientific.

Responsibilities:

  • Support existing commercial manufacturing and new product introduction including the optimization of existing process by introducing new technologies
  • Providing solutions to technical problems that may arise during production or the life cycle of projects
  • Make recommendations for the improvement of any procedures or processes that will result in better efficiency, cost reduction, and/or improved product quality
  • Evaluate existing manufacturing processes and identify areas for improvement
  • Proposes, writes, updates, and reviews Standard Operating Procedures (SOP’s)
  • Assist Manufacturing with production floor issues related to the manufacturing process, including research into customer complaints
  • Support the implementation of new process equipment, including but not limited to Design, Procurement, cGMP documentation, commissioning and qualification activities
  • Provide cross-functional support to manufacturing, sales & marketing, supply chain, facilities, validation and quality. Support the investigation of non-conformance events and implement corrective & preventative actions as applicable

Experience/Education:

  • Bachelor of Science in engineering, or similar scientific background/experience
  • 5+ years in a manufacturing support or engineering role preferably in the Pharmaceutical, Medical Device or Biological Industry
  • Knowledge of cGMP, FDA regulations and/or medical device manufacturing experience is required.
  • Ability to identify engineering problems or opportunities and develop / present feasible solutions.
  • Demonstrated ability to manage and lead engineering projects related to productivity improvement, cost savings, capacity expansion or new process development
  • Experience in Current Good Manufacturing Practices (cGMP) industry and demonstration of concepts of Lean Manufacturing and Six Sigma quality techniques
  • Knowledge and experience working within the quality system, including investigation resolution, CAPA implementation, and Chance Control procedures
  • Experience with scale up tech transfers from R&D to Manufacturing
  • Proficient in Word, Excel, PowerPoint, Outlook, Project software
  • Must possess excellent technical writing ability

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Principals only. No recruiters please.

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.

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