Project Engineer

Engineering | Irvine, CA

Job Description:

We are hiring a Project Engineer. The Project Engineer will be responsible for the execution of strategic CAPEX and other related engineering projects to improve efficiency & quality of product while reducing cost & complexity.

Responsibilities:

  • Lead the implementation of assigned engineering projects.
  • Develop equipment/system specifications, identify infrastructure requirements and perform feasibility assessments as required for each project.
  • Review, markup and ensure project documents such as specifications, submittals, and RFIs, test documents, drawings, and/or other project specific documents are created and documented accurately.
  • Work with outside vendors and contracting firms to bring projects from concept to implementation
  • Provide solutions to technical problems that may arise during the life cycle of projects.
  • Support project activities with designers, contractors, and vendors.
  • Work with contractors during project implementation as required.
  • Work with quality and validation to ensure proper testing, inspection, validation and release of projects.
  • Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required
  • Ensure new equipment operates in compliance with required EHS, regulations and codes.
  • Develop, write, edit and/or review in collaboration with cross functional team SOPs, P&IDs and other procedures for new equipment and/or systems.
  • Able to work with other contractors, manufacturing, validations and quality personnel regarding changes or improvements to the systems.

Experience/Education:

  • Bachelor of Science in Engineering, or similar scientific background experience.
  • 5 years engineering experience
  • 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
  • Project Management
  • 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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