Downstream Process Engineer 3
2 days ago
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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