Downstream Process Engineer

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