Senior Process Engineer
Intellectt INC
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.
Vacancy posted 5 days ago
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