Careers

Sr. Process Engineer

Engineering | Santa Ana | CA

Job Function:
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.

 

Job Duties:

  • 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

 

Apply Now

 

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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