Process Engineer

Process Engineer

Location: Wilson, NC (Onsite),
Duration: 12-Month Contract

Seeking experienced Process Engineers to support a large-scale greenfield biologics manufacturing facility in the Raleigh-Durham area. The selected candidates will serve as Process System Owners (SMEs) responsible for the design, implementation, commissioning, startup, and operational support of critical GMP manufacturing systems. This role focuses on process engineering ownership, technical leadership, system design, and startup support rather than traditional CQV activities.

• Serve as Process System Owner (SME) for assigned manufacturing systems and process areas.
• Lead process engineering activities throughout the project lifecycle, including design, construction, commissioning, startup, and operational readiness.
• Develop and review User Requirements Specifications (URS), Functional Requirements Specifications (FRS), P&IDs, process flow diagrams, and technical documentation.
• Collaborate with Architectural & Engineering (A&E) firms, EPCM partners, equipment vendors, and project teams to support system design and implementation.
• Support equipment selection, procurement, installation, integration, and startup activities.
• Provide hands-on troubleshooting and technical support for process systems during commissioning, startup, and routine operations.
• Drive technology transfer, process optimization, and fit-to-plant activities.
• Partner with Manufacturing, Quality, Automation, Validation, Maintenance, and Engineering teams to ensure project success.
• Conduct risk assessments, root cause investigations, deviation management, CAPA implementation, and continuous improvement initiatives.
• Ensure compliance with cGMP, FDA, and regulatory requirements.
• Support "Right First Time" project execution and operational readiness.

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or related Engineering discipline.
• Proven experience as a Process Engineer, Process Owner, or System Owner within a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
• Strong experience developing process concepts into engineering designs and technical requirements.
• Demonstrated expertise in troubleshooting and optimizing complex manufacturing process systems.
• Experience supporting greenfield, brownfield, large capital projects, facility expansions, or construction-driven environments.
• Working knowledge of DeltaV Distributed Control System (DCS).

• Master's Degree, MBA, or PhD in Engineering or related discipline.
• Lean Manufacturing and/or Six Sigma certification.
• Experience supporting biologics, biotechnology, vaccine, or pharmaceutical manufacturing facilities.
• Strong understanding of process control, automation integration, and manufacturing startup activities.