Process Engineer

Role

Process Engineer – Buffer Preparation & CIP Systems

Bradley, IL (Onsite)

The Process Engineer / System Owner will lead engineering activities associated with buffer preparation, distribution, and CIP systems supporting plasma-derived biologics manufacturing operations. The role is responsible for ensuring systems meet operational, regulatory, safety, and project requirements from design through qualification and handoff to operations.

The successful candidate will possess significant experience with buffer preparation, process liquids management, and cleaning systems commonly used in large-scale biologics manufacturing facilities.

• Act as System Owner for buffer preparation and CIP systems.
• Support all project phases including design, construction, commissioning, qualification, and startup.
• Participate in technical reviews and vendor coordination activities.
• Develop and review:
• User Requirements Specifications (URS)
• Technical Specifications
• Design Documentation
• Coordinate across engineering, operations, CQV, validation, and automation teams.
• Oversee system turnover and operational readiness activities.

• Buffer preparation systems
• Clean-In-Place (CIP) systems
• Solids handling and conveyance
• Powder transfer systems
• Buffer makeup operations
• Batch buffer preparation
• Duty/standby buffer supply systems

• BS in Engineering or related technical discipline.
• 8+ years of pharmaceutical, biologics, or plasma manufacturing experience.
• Demonstrated experience with:
• CIP system design and operation
• Buffer preparation systems
• GMP manufacturing environments
• Experience supporting startup, commissioning, and qualification programs.

• Plasma fractionation manufacturing experience.
• CIP and buffer systems for large-scale biologics facilities.
• Previous System Owner or Work Package Owner experience.