What are the responsibilities and job description for the Process Engineer/System Owner - PTC (Pooling,Thawing & Centrifugation) position at Tekhawks LLC?
Title: Process Engineer / System Owner – PTC (Pooling, Thawing & Centrifugation)
Location: Bradley, IL
Duration: 12 Months - Extension
Position Summary
The Process Engineer / System Owner will provide technical leadership and ownership for Pooling, Thawing, and Centrifugation (PTC) systems within a large-scale plasma fractionation manufacturing project. The resource will ensure assigned equipment and systems are designed, installed, commissioned, qualified, and transitioned to operations in accordance with project requirements, GMP standards, and Client engineering practices.
This role serves as the primary technical lead for PTC process systems and collaborates closely with Engineering, Automation, CQV, Validation, Operations, Construction, and Equipment Vendors.
Key Responsibilities
Act as System Owner for assigned PTC equipment and process systems.
Support design, installation, commissioning, qualification, and startup activities.
Participate in equipment and piping design reviews.
Develop and review URS, Functional Specifications, Risk Assessments, and technical documentation.
Provide technical oversight for:
Plasma bottle opening systems
Plasma pooling systems
Plasma thawing systems
Centrifugation equipment
Parts washers
Ensure equipment complies with GMP, safety, and operational requirements.
Coordinate vendors, contractors, and internal stakeholders.
Support CQV strategy development and execution.
Manage technical risks, issues, and deviations.
Assist with operational readiness and turnover activities.
Required Qualifications
BS in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, or related discipline.
8 years of pharmaceutical, biologics, or plasma fractionation experience.
Experience supporting large capital projects or facility expansions.
Strong knowledge of:
Plasma processing operations
Centrifugation systems
Process equipment commissioning and qualification
GMP manufacturing environments
Experience with system ownership responsibilities.
Preferred Qualifications
Plasma fractionation industry experience.
Siemens PCS7 familiarity.
Salary : $50 - $58