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Sr. Process Engineer

FISI - FUJIFILM Irvine Scientific Santa Ana Full-Time
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Irvine Scientific, a member of Fujifilm Holdings Corporation, 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 cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large- scale production of biotherapeutics and vaccines. 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 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.

We are hiring for a Sr. Process Engineer. The Sr. Process Engineer will be responsible for optimization of manufacturing processes / equipment to improve the consistency & quality of products while reducing cost & complexity. This role will also own the “Tech Transfer” process, and will be responsible to ensure the process is performing the desired function, and use the process to transition new products from R&D through pilot phase and into full scale production. The Sr. Process Engineer will also be responsible for assigned engineering (& related) projects in the design, construction, implementation, maintenance and improvement of manufacturing processes and facilities.


External US


  • Coordinate and conduct lean activities including but not limited to workshops, A3’s, Kaizen events, training, and corporate assessments
  • Attend Kaizen events, training, and perform corporate assessments
  • Provide direction and assistance in developing lean roadmaps and lean metrics to drive implementation
  • Ensure lean materials (e.g. best practices, training) are efficiently applied to all sites (ISCA, IST)
  • Provide coaching / teaching to senior management to ensure their complete understanding of lean and their role in the change process
  • Provide coaching / teaching to all sites on lean concepts; serve as an expert resource
  • Leverage industry knowledge and trends into improving corporate materials and Continuous improvement initiatives
  • Work effectively with all levels and functions of the organization to advance lean
  • Provide innovative and creative solutions to advance lean
  • Work independently with minimal direction
  • Evaluating manufacturing equipment & processes on a regular basis and making well-reasoned recommendations for improvements that will result in better efficiency, cost reduction and/or improved product quality
  • Acts as the driving force for the project, coordinating all resources and activities necessary to ensure on time execution to the project or process improvement plan, identify and work through barriers that hinder progress
  • Responsible for managing all PM plans and tasks within assigned area to ensure effective completion of maintenance according to PM schedule
  • Follow up on machine breakdowns with any necessary updates to the PM system to facilitate continuous improvement of machine reliability
  • Required to prepare process job descriptions and manufacturing specifications, thoroughly documents all equipment, machines, and tooling with accurate and clear detailed prints and maintenance instructions
  • With the assistance of the validation team, creates all necessary documentation associated with the change control process and coordinates validation activities to ensure on time execution according to the project or process improvement plan 
  • Provides technical guidance as needed to manufacturing and hourly technical personnel during the startup of new or changed products and processes
  • Uses good decision making, problem solving and trouble-shooting techniques to minimize the potential or correct ongoing manufacturing issues
  • Prepares a plan for procurement of capital equipment including obtaining of quotes, vendor investigation, budgeting, and scheduling. Prepares specifications, place orders, coordinate procurement, install equipment, debug and coordinate the startup of new or modified equipment from outside firms or as modified internally, manages capital spending on assigned projects to ensure spending in accordance with the plan capital budget 
  • Coordinate design activity with outside vendors or internal departments as necessary. If resources are unavailable, perform own design and drafting as required.  Redesigns or oversees the redesign of existing equipment to incorporate improvements relating to safety, machine reliability, product quality, and / or cost reduction

Experience/ Education:

  • B.S. in Mechanical, Industrial or Chemical Engineering
  • 10 years Process Engineering experience
  • Knowledge of cGMP, FDA regulations and/or medical device manufacturing experience is desired
  • Demonstrated ability to lead engineering projects related to productivity improvement, cost savings, capacity expansion or new process development
  • Ability to read a blueprint
  • Project Management
  • Design Control
  • 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

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.


Recommended skills

Process Development
Business Process Improvement
Process Engineering
Change Control


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Job ID: 2019-4182


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