Process Engineer

Title: Senior Process Engineer – Bulk PurificationLocation: Chicago, Illinois Position Summary:The Senior Process Engineer / System Owner will provide engineering leadership for bulk purification operations supporting plasma-derived therapeutics manufacturing. This individual will own downstream processing systems throughout design, construction, commissioning, qualification, startup, and handover activities.Key Responsibilities:• Serve as System Owner for bulk processing and purification systems.• Provide technical leadership during design, construction, startup, and CQV phases.• Review and approve engineering deliverables and vendor documentation.• Lead system readiness and qualification activities.• Ensure alignment between process requirements and project deliverables.• Support troubleshooting and issue resolution.Areas of Ownership• Anion Exchange Chromatography• Immunoaffinity Chromatography• Simulated Moving Bed (SMB) Chromatography• Chromatography Column Handling and Packing• Ultrafiltration/Diafiltration (UF/DF)• Virus Nanofiltration• Bulk Product Transfer and Hold SystemsRequired Qualifications• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related discipline.• 10+ years of biologics, plasma fractionation, or downstream processing experience.• Strong expertise in:o Chromatography operationso UF/DF systemso Virus filtration technologieso Downstream process equipment• Experience supporting CQV and startup activities.• Experience as a System Owner, Process Lead, MSAT Engineer, or Manufacturing Engineer.Preferred Qualifications• Plasma-derived therapeutics manufacturing experience.• Large-scale purification expertise.• Siemens automation experience.• Greenfield and/or brownfield capital project experience.