Downstream Process Engineer

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 is seeking multiple Downstream Process Equipment Engineers to support startup activities for a large-scale biologics manufacturing expansion project. These roles will support installation verification, commissioning, startup, and operational readiness activities for downstream process equipment within a GMP biopharmaceutical manufacturing environment. This person will sit onsite 5 days a week in the Raleigh, NC area.

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 cross-functionally with vendors, construction teams, CQV, operations, and QA teams to resolve installation and startup issues
• Review equipment layouts and installations using Navisworks or similar 3D modeling software
• Participate in investigations, deviations, CAPA activities, and risk assessments related to assigned systems
• Assist with campaign changeover strategies and LOTO identification activities
• Support troubleshooting and field execution activities during critical startup phases
• Ensure systems are installed and operating in compliance with GMP standards and project requirements

Qualifications

• Bachelor’s degree in Chemical Engineering or related engineering discipline
• 3–8 years of engineering experience within GMP biopharmaceutical manufacturing environments
• Hands-on experience supporting downstream process equipment in biologics or monoclonal antibody manufacturing facilities
• Strong experience performing P&ID walkdowns, installation verification, and startup support activities
• Experience interacting directly with vendors, contractors, and cross-functional project teams
• Familiarity with GMP investigations, deviations, CAPA processes, and risk assessments
• Experience utilizing Navisworks or comparable 3D model review software
• Understanding of campaign changeover activities and basic LOTO concepts
• Strong troubleshooting and field execution capabilities within fast-paced startup environments

Preferred Experience

• Experience supporting one or more of the following downstream systems:
• Buffer and product hold vessels
• Chromatography skids
• UF/DF (Ultrafiltration/Diafiltration) systems
• Knowledge of CIP/SIP systems and stainless-steel process equipment
• Familiarity with common downstream equipment vendors such as Cytiva/GE or Sartorius
• Understanding of UF/DF operational concepts including TMP, flux, and diafiltration