Downstream Process Engineer 3

2 days ago


Holly Springs NC USA, United States FUJIFILM Corporation Full time
About the Role:

Fujifilm Corporation is seeking a highly skilled Downstream Process Engineer 3 to join our team in Holly Springs, North Carolina. As a key member of our Process Engineering team, you will be responsible for supporting the development and implementation of downstream process equipment and systems.


Key Responsibilities:


  • Develop and align plans for moderate complexity equipment packages
  • Secure on-time delivery and ensure quality from Fujifilm and EPCM provider
  • Review piping and instrumentation diagram (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 Acceptance Testing (FAT), 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 or assist with deviations, change controls, 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(s)
  • Participate in identifying 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 5 years of Engineering or other relevant technical experience; or Master's in Chemical or Biotechnology Engineering with 3 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)

Preferred Requirements:
  • Prior experience working in a cGMP environment or other highly regulated industry
  • Experience working in at least one unit operation in a pharmaceutical or Life Science environment
  • Experience with mammalian cell culture processes


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