Job Title: Process Engineer / System Owner – PTC (Pooling, Thawing & Centrifugation)
Location: Bradley, IL
Duration: 3 month+
Interview Mode: video screening
Job Description:
candidates that have worked at companies like Takeda, Grifols, Octapharma, ADMA and Kedrion will be potential matches for these roles.
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:
o Plasma bottle opening systems
o Plasma pooling systems
o Plasma thawing systems
o Centrifugation equipment
o 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:
o Plasma processing operations
o Centrifugation systems
o Process equipment commissioning and qualification
o GMP manufacturing environments
• Experience with system ownership responsibilities.
Preferred Qualifications
• Plasma fractionation industry experience.
• Siemens PCS7 familiarity.
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