Senior Process Engineer

1 day ago

Holly Springs, Georgia, United States Fujifilm Corporation Full time
Job Summary

This is a challenging opportunity for a highly skilled Process Engineer to join our team at Fujifilm Corporation. As a key member of our Process Engineering team, you will be responsible for supporting the Aura project, a greenfield expansion construction project in Holly Springs, NC. Your primary focus will be on assuming the Responsible Engineer role for the Product Hold unit operation.

Key Responsibilities
  • Serve as the point of contact to the Engineering, Procurement, Construction Management (EPCM) provider for high complexity equipment packages.
  • Ensure on-time delivery and quality from Fujifilm and EPC provider for high complexity equipment packages.
  • Develop and align high complexity plans and provide mitigations, as needed.
  • Review piping and instrumentation diagrams (P&IDs) and other process design documents.
  • Provide direction to detailed design activities in partnership with the EPCM provider.
  • Write User Requirement Specifications (URSs).
  • Support Factory Assessment Tests (FATs), Commissioning, Qualification and Validation (CQV), and start-up activities.
  • Serve as on-call support for process equipment.
  • Review, redline, and approve P&IDs and other technical documents, as the technical authority.
  • Lead system impact assessments and quality risk assessments for process equipment.
  • Perform technology transfer (TT) activities related to process equipment.
  • Support execution of Good Manufacturing Practices (GMP) runs.
  • Provide technical support for root cause analysis (RCA) and process deviation investigations.
  • Lead deviation and corrective and preventive action (CAPA) closures.
  • Make decisions regarding technical risk assessments for new manufacturing equipment.
  • Provide on-floor manufacturing support for equipment issues.
  • Provide process equipment training and consultation on topics within assigned area.
  • Identify continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield, and cost.
  • Support supplier technical evaluations, risk assessments, and equipment evaluation and qualification.
  • Conduct training and present information to team or other stakeholders.
  • Cross-train on unit operations to assist team with achieving deliverables.
  • Collaborate with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation.
Requirements
  • Bachelor's degree in Chemical or Biotechnology Engineering, or another related field with 8 years of Engineering or other relevant technical experience; or Master's degree in Chemical or Biotechnology Engineering with 6 years of Engineering or other relevant technical experience.
  • Experience in Life Science or other regulated industry.
  • Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system).
  • Proficient experience in multiple unit operations within the assigned plant section.
Preferred Requirements
  • Prior experience working in a cGMP environment or other highly regulated industry.
  • Experience with large scale mammalian cell culture processes, ≥ 2000L.
  • Large scale capital project experience, > $500M USD.

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