Senior Process Engineer-PTC

Senior Process Engineer-PTC

Chicago Heights, IL

Position Summary

The Senior Process Engineer will serve as the technical system owner for Pooling, Thawing, and Centrifugation (PTC) process systems supporting a major plasma-derived therapeutics manufacturing expansion. This role is responsible for providing engineering oversight, vendor management, commissioning support, troubleshooting, and operational readiness activities for specialized plasma processing equipment.

The successful candidate will possess extensive experience with plasma fractionation or related biologics manufacturing processes and demonstrate strong mechanical aptitude, equipment ownership, and vendor management capabilities.

Key Responsibilities

• Serve as System Owner for PTC process equipment and associated systems.
• Support design review, construction, commissioning, startup, CQV, and operational handover activities.
• Provide technical leadership for:
• Plasma bottle opening systems
• Plasma thawing systems
• Pooling systems
• Centrifugation equipment
• Parts washers
• Participate in FATs, SATs, equipment acceptance, and startup activities.
• Manage vendors and equipment suppliers, ensuring timely resolution of technical issues.
• Lead troubleshooting efforts for equipment and process performance issues.
• Support development and review of:
• URS
• Technical Specifications
• Risk Assessments
• Turnover documentation
• Interface with Construction, Automation, CQV, Operations, Validation, and Engineering teams.
• Support operational readiness and handover to manufacturing.

Required Qualifications

• BS Engineering or related discipline.
• 8+ years of pharmaceutical, biologics, or plasma manufacturing experience.
• Experience supporting process equipment through startup and qualification.
• Strong mechanical troubleshooting skills.
• Experience managing equipment vendors and contractors.
• Knowledge of GMP manufacturing environments.
• Preferred Qualifications
• Plasma fractionation experience.