Job Description

Insight Global is seeking a Principle Process Engineer to work at one of our largest pharmaceutical manufacturing companies in Durham, NC. The Principal Process Engineer will own manufacturing process equipment and ensure site infrastructure supports cGMP operations. This role focuses on equipment design, implementation, troubleshooting, and continuous improvement for upstream and downstream bioprocessing systems, with a strong emphasis on single-use technologies.

Key Responsibilities

• Serve as system owner for upstream and downstream process equipment, including single-use bioreactors (up to 2000L), filtration systems, and chromatography skids.
• Define equipment requirements, specifications, and standards for facility fit; support installation, commissioning, qualification, and validation.
• Lead equipment-focused projects: upgrades, new installations, and process improvements; develop business cases and manage timelines and budgets.
• Collaborate with MS&T, Manufacturing, Quality, and Engineering teams to troubleshoot equipment issues and ensure GMP compliance.
• Author and maintain SOPs, engineering studies, and process documentation; support CAPA, change control, deviation investigations, and risk assessments.
• Evaluate and implement new technologies (e.g., single-use systems, PAT tools) to enhance scalability and efficiency.
• Support capital projects, including facility design and equipment selection.
• Represent process engineering in audits and regulatory filings.

Technical Focus

• Upstream: Mammalian cell culture, seed expansion, harvest, filtration; single-use bioreactors (2000L scale).
• Downstream: Chromatography (capture/exchange columns), single-use skids, filtration systems.
• Familiarity with Unicorn (method development), Wonderware, and Allen Bradley FactoryTalk for process control.
• Experience with P&IDs, cleaning validation, and GMP documentation.

Requirements

• Bachelor’s or Master’s in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• 10+ years in bioprocess engineering within biotech or biopharmaceutical manufacturing.
• Expertise in upstream and downstream processes, single-use technologies, and GMP compliance.
• Strong troubleshooting, project management, and cross-functional collaboration skills.

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