Senior Process Engineer

Job Title: Senior Process Engineer
Location: Illinois
Employment Type: Contract W2
Duration: 6+ Months
Rate: $53 $65/hr W2

About the Role:
We are seeking a Senior Process Engineer to serve as the technical system owner for Pooling, Thawing, and Centrifugation (PTC) process systems supporting a major plasma-derived therapeutics manufacturing expansion. This role will provide engineering oversight, vendor management, commissioning support, troubleshooting, and operational readiness for specialized plasma processing equipment.

Responsibilities:

• Serve as the System Owner for PTC process equipment and associated systems.
• Support design reviews, construction, commissioning, startup, CQV, and operational handover.
• Provide technical leadership for plasma bottle opening, thawing, pooling, centrifugation, and parts washer systems.
• Participate in FAT, SAT, equipment acceptance, startup, and qualification activities.
• Manage equipment vendors and suppliers and drive resolution of technical issues.
• Lead troubleshooting of equipment and process performance issues.
• Develop and review URS, technical specifications, risk assessments, and turnover documentation.
• Coordinate with Construction, Automation, CQV, Operations, Validation, and Engineering teams.
• Support manufacturing readiness and successful equipment handover to operations.

Required Qualifications:

• Bachelor's degree in Engineering or a related discipline.
• 8+ years of experience in pharmaceutical, biologics, plasma, or related manufacturing environments.
• Experience supporting process equipment through startup, commissioning, and qualification.
• Strong mechanical aptitude and troubleshooting skills.
• Experience managing equipment vendors, suppliers, and contractors.
• Working knowledge of GMP manufacturing environments.
• Strong communication, technical documentation, and cross-functional collaboration skills.

Preferred Qualifications:

• Direct experience with plasma fractionation or plasma-derived therapeutics manufacturing.
• Experience with Pooling, Thawing, and Centrifugation (PTC) systems.
• Experience with FAT/SAT, CQV, equipment qualification, and operational readiness.
• Experience working with plasma manufacturing organizations such as CSL, Takeda, Grifols, Octapharma, Kedrion, or ADMA.