Process Engineer 2

About the position

This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Aura project, a greenfield construction project in Holly Springs, NC. The initial assignment is to assume the Responsible Engineer role for Chromatography and Column Packing unit operations. As the site moves into commercial operations circa 2027, this position is planned to continue as primary support for Chromatography and Column Packing unit operations, with secondary responsibility expanding to cover additional Downstream unit operations includes supporting commercial operations, technology transfers, and small capital projects.

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).
• Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities.
• 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.
• Performs technology transfer (TT) activities related to process equipment.
• Supports execution of Good Manufacturing Practices (GMP) runs.
• Provides technical support for root cause analysis (RCA) and process deviation investigations.
• Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures.
• Makes decisions regarding technical risk assessments for new manufacturing equipment.
• Provides on-floor manufacturing support for equipment issues.
• Provides process equipment training and consultation on topics within assigned area.
• 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).

Nice-to-haves

• 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.