Process Engineer

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.

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.

Clean-In-Place (CIP) Systems

Buffer Makeup Operations

Inline Dilution Systems

Powder Transfer Systems

Solids Handling & Conveyance

Duty/Standby Buffer Supply Systems

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.

Plasma fractionation manufacturing experience.

Large-scale biologics manufacturing experience.

Previous System Owner or Work Package Owner experience.