Process Engineer 3 - Media and Buffer Prep

Overview

This position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Galaxy project, a greenfield construction project in Holly Springs, NC.  The initial assignment is to assume the Responsible Engineer role for Media and Buffer Prep unit operations. 

As the site moves into commercial operations circa 2025, this position is planned to continue as a Process Engineering role supporting commercial operations, technology transfers, and small capital projects related to the same unit operations.  Additional details regarding job responsibilities are below. 

External US

Primary Accountabilities

 

• Serves as point of contact to the Engineering, Procurement, Construction Management (EPC) provider• Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packages• Develops and aligns moderate complexity plans and provides mitigations, as needed• Reviews piping and instrumentation diagram (P&IDs) and other process design documents• Provides direction to detailed design activities in partnership with the EPCM provider• Writes User Requirement 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 as the technical authority• Leads 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(s)• Participates in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield and cost • Supports supplier technical evaluations, risk assessments, and equipment evaluation and qualification• Conducts training and presents information to team or other stakeholders • Cross-trains on unit operations to assist team with achieving deliverables• Collaborates 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)

• Experience in a cGMP environment