Process Engineer

Overview

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 Process Engineer. The 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 Process Engineer will also be responsible for assigned engineering (& related) projects in the design, construction, implementation, maintenance and improvement of manufacturing processes and facilities.

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External US

Responsibilities:

• Evaluate manufacturing equipment & processes on a regular basis and make well-reasoned recommendations for improvements that will result in better efficiency, cost reduction and/or improved product quality
• Research and recommend new equipment and/or manufacturing processes
• Evaluate the Tech Transfer process and make improvements to assure optimum performance
• Follow the process and ensure that new products or formulas are moved from R&D through pilot scale and into full production with all required steps and approvals in place
• Present well-reasoned and detailed analysis of scale-up issues, and work collaboratively with others to ensure that cost, performance, safety and other issues are identified as early as possible and are resolved rapidly and permanently
• Provide risk/benefit/cost analysis to facilitate rapid & informed decision making
• Lead and support tech transfer by providing technical specification and risk assessments for new manufacturing processes
• Interpret and communicate results to the tech transfer team
• Proactively identify and understand operational challenges; bring innovative solutions
• Design sampling protocols related to process validation
• Lead troubleshooting and process improvement projects
• Contribute to the management of manufacturing data and the statistical analysis of these data aimed at both long term trending and the resolution of investigations
• 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:

• B.S. in Mechanical or Industrial Engineering, Biology, or Chemistry
• Three years in an R&D or Manufacturing support role, preferably in the Pharmaceutical, Medical Device, or Biological industry
• GMPs, ISO
• 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

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.