Downstream Process Engineer: GMP Startup & Commissioning

Technical Source; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Technical Source in Raleigh, NC seeks multiple Downstream Process Equipment Engineers to support startup activities for a large-scale biologics manufacturing expansion project. These roles will be onsite 5 days a week in the Raleigh, NC area.

Responsibilities include leading system ownership, field P&ID walkdowns, verification of installed equipment, and supporting commissioning and startup of downstream systems in a GMP biopharmaceutical environment.

Qualifications

• Hands-on experience performing P&ID walkdowns and installation verification in GMP biopharmaceutical environments.
• Experience supporting downstream process equipment in biologics or related facilities.
• Familiarity with GMP investigations, deviations, CAPA processes, and risk assessments.

Responsibilities

• Serve as system owner for assigned downstream process equipment systems.
• Perform field-based P&ID walkdowns and redline discrepancies for resolution.
• Verify installed equipment and piping against approved engineering and design documentation.
• Support commissioning, startup, and early operations activities for downstream systems.
• Collaborate with vendors, construction teams, CQV, operations, and QA to resolve issues.
• Review equipment layouts and installations using Navisworks or similar 3D modeling software.
• Participate in investigations, deviations, CAPA activities, and risk assessments for the systems.
• Assist with campaign changeover strategies and LOTO identification activities.
• Support troubleshooting and field execution during critical startup phases.
• Ensure systems are installed and operating in GMP compliance and project requirements.

Skills

P&ID walkdowns

GMP knowledge

Cross-functional collaboration

Startup support

3D modeling review

Education

Bachelor’s degree in Chemical Engineering

Tools

Navisworks

Job description

Technical Source in Raleigh, NC seeks multiple Downstream Process Equipment Engineers to support startup activities for a large-scale biologics manufacturing expansion project. These roles will be onsite 5 days a week in the Raleigh, NC area.

Responsibilities include leading system ownership, field P&ID walkdowns, verification of installed equipment, and supporting commissioning and startup of downstream systems in a GMP biopharmaceutical environment.