Process Engineer
INTELLECTT INC
TWe are seeking an experienced Process Engineer / System Owner to lead engineering activities for Buffer Preparation, Buffer Distribution, and Clean-In-Place (CIP) systems supporting a large-scale plasma-derived biologics manufacturing facility. The successful candidate will be responsible for system ownership throughout the project lifecycle, including design, construction, commissioning, qualification, startup, and transition to operations. Key Responsibilities Serve as the System Owner for Buffer Preparation and CIP systems. Lead engineering activities from design through operational handover. Participate in process design reviews, equipment selection, and vendor coordination. Develop and review User Requirements Specifications (URS), Technical Specifications, Functional Specifications, and Risk Assessments. Collaborate with Engineering, Automation, CQV, Validation, Operations, and Construction teams. Support commissioning, qualification (IQ/OQ/PQ), and startup activities. Ensure systems comply with GMP, safety, quality, and regulatory requirements. Drive operational readiness, turnover, and issue resolution. Areas of Ownership Clean-In-Place (CIP) Systems Buffer Makeup Operations Inline Dilution Systems Powder Transfer Systems Solids Handling & Conveyance Duty/Standby Buffer Supply Systems Required Qualifications Bachelor's degree in Engineering or related technical discipline. 8+ years of experience in pharmaceutical, biologics, or plasma manufacturing. Hands-on experience with: CIP System Design & Operation GMP Manufacturing Experience supporting commissioning, qualification (CQV), startup, and system handover. Preferred Qualifications Plasma fractionation manufacturing experience. Large-scale biologics manufacturing experience. Previous System Owner or Work Package Owner experience. #J-18808-Ljbffr
Vacancy posted 22 hours ago
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