Process Engineer 2, Visual Inspection

About the role

The Process Engineer 2 supports Drug Product Finished Goods (DPFG) within the assigned area(s) [Visual Inspection]. They provide engineering guidance to stakeholders throughout the organization to support capital projects, technology transfer, and manufacturing operations while ensuring processes are efficient, scalable, and compliant with CGMP regulations.

Responsibilities

• Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
• Secures on-time delivery and ensures quality from Fujifilm EPCM provider for equipment packages with limited complexity
• Develops and aligns basic plans and provides mitigations, as needed
• Reviews piping and instrumentation diagrams (P&IDs) and other process design documents
• Provides direction to detailed design activities in partnership with the EPCM provider
• Writes User Requirements Specifications (URSs)
• Serves as on-call support for process equipment
• Reviews, redlines, and approves P&IDs and other technical documents with limited supervision
• Performs system impact assessments and quality risk assessments for process equipment
• Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities
• Supports execution of Good Manufacturing Practices (GMP) runs
• Provides technical support for root cause analysis (RCA) and process deviation investigations
• Makes decisions regarding technical risk assessments for new manufacturing equipment
• Provides on-floor manufacturing support for equipment issues
• Supports continuous improvement projects in partnership with Maintenance and Manufacturing
• Cross-trains on multiple unit operations to assist team with achieving deliverables
• Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation
• Other duties, as assigned

Requirements

• Bachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 2 years of Engineering experience; or Master’s degree in Chemical or Biotechnology Engineering with no prior experience
• Experience in a Life Science or other regulated industry
• Experience with Engineering drawings and using 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
• Prior experience with mammalian cell culture processes

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!