Process Engineer II

Role:- Process Engineer – Buffer Preparation & CIP Systems

Location: Bradley, IL (Onsite)

Position Summary

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.

Key Responsibilities

• 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
  • Risk Assessments
  • Design Documentation
• Coordinate across engineering, operations, CQV, validation, and automation teams.
• Oversee system turnover and operational readiness activities.

Areas of Ownership

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