What are the responsibilities and job description for the Process Engineer / System Owner - Buffer Preparation & CIP Systems position at Tekhawks LLC?
Title: Process Engineer / System Owner – Buffer Preparation & CIP Systems
Location: Bradley, IL
Duration: 12 Months - Extension
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
Required Qualifications
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
Process liquids management
GMP manufacturing environments
Experience supporting startup, commissioning, and qualification programs.
Preferred Qualifications
Plasma fractionation manufacturing experience.
CIP and buffer systems for large-scale biologics facilities.
Siemens PCS7 exposure.
Previous System Owner or Work Package Owner experience.
Salary : $55 - $58