Downstream Process Engineer Job at Technical Source, Raleigh, NC

  • Technical Source
  • Raleigh, NC

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

Job Tags

Full time, For contractors

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