Job Summary We're looking for a Senior Process Engineer / System Owner to support a major plasma-derived therapeutics manufacturing expansion.This role will own Pooling, Thawing, and Centrifugation (PTC) process systems and support design, commissioning, startup, CQV, troubleshooting, vendor management, and operational readiness.
Key requirements:
BS in Engineering or related discipline
8+ years of pharmaceutical, biologics, plasma, or related GMP manufacturing experience
Strong process equipment and mechanical troubleshooting experience
Experience with commissioning, startup, and qualification
Strong vendor/supplier management experience
Experience with URS, technical specifications, risk assessments, and turnover documentation
Excellent communication and cross-functional collaboration skills
Preferred:
Plasma fractionation experience
Experience with pooling, thawing, centrifugation, or related plasma processing equipment
Siemens PCS 7 exposure
Experience in plasma manufacturing environments
Numbers & Facts
Location
NULL, IL
Salary
$55–$85
Skills
Biotech and Pharmaceuticalunmatched
Commissioningunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Documentationunmatched
GMP (Good Manufacturing Practices)unmatched
Identify Issuesunmatched
Manufacturingunmatched
Plasmaunmatched
Plasma Processingunmatched
Process Engineeringunmatched
Risk Analysisunmatched
Startupunmatched
Systems Engineeringunmatched
Team Playerunmatched
Vendor/Supplier Managementunmatched
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