Downstream Process Engineer

Insight Global is seeking several Downstream Process Engineers to support of the Process Equipment team for one of our largest pharmaceutical manufacturing companies in Holly Springs, NC. The assignment is to assume the Responsible Engineer role for Down Stream Process Engineering, Buffer Prep and Hold unit operations. As the site prepares for commercial operations starting in 2026 the position is to support the final CQV activities and manufacturing operations startup activities centered around the Buffer Prep and Buffer Hold unit operations of Mixing, Transfer and Hold of Buffers. Secondary responsibility includes supporting commercial operations, technology transfers, and small capital projects.

The Process Engineer provides engineering guidance to support capital projects, technology transfer, and manufacturing operations to ensure compliance with all safety, regulatory, and engineering requirements. This role adheres to product and customer requirements and work towards optimizing plant efficiency and profitability.

The Buffer Prep and Hold Process Engineer shall have specific unit operations experience in a mAB (monoclonal antibodies) production to include set up, operations, and troubleshooting.

• Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
• Secures on time delivery and ensures quality from EPCM provider for equipment packages with limited complexity
• Develops and aligns basic plans and provides mitigations, as needed
• Provides direction to detailed design activities in partnership with the EPCM provider
• Writes User Requirements Specifications (URSs)
• Reviews piping and instrumentation diagrams (P&IDs) and other process design documents
• Supports 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, Maintenance, Validation, and Safety.

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