About the role
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
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