Engineering Project Manager - Process Equipment
$170,000–$198,000 year
On-site · Raleigh, North Carolina, United States
Job Summary
Engineering Project Manager for downstream stainless-steel DS systems overseeing schedule, planning, and scope from design completion through FAT, SAT, commissioning, and qualification. Partners with scheduling teams and cross-functional stakeholders to define tasks, sequence, and ownership, manage FAT/SAT readiness, and ensure readiness for equipment startup. Responsibilities include defining system boundaries, coordinating with engineering, automation, C&Q, operations, and vendors; developing detailed FAT/SAT schedules; identifying gaps and risks; and contributing to change control and cross-functional communication.
Required Qualifications
- Bachelor’s degree in Engineering (Chemical, Mechanical, Process, or related) with 8+ years of engineering/project experience, OR Master’s degree with 6–8 years of experience, OR Associate’s degree with 10+ years of engineering experience.
- Significant experience as a Project Manager on capital projects in GMP biotech/pharma or a closely related regulated industry.
- Strong background with stainless-steel process equipment, preferably in downstream Drug Substance (chromatography, UF/DF, filtration, tanks).
- Demonstrated experience owning a defined workstream within an integrated project schedule, in collaboration with project controls/scheduling.
- Solid understanding of downstream unit operations and how stainless-steel equipment is integrated into DS manufacturing (system-level understanding).
- Experience working with or defining system boundaries and cross-functional interfaces for process systems.
- Direct involvement in FAT/SAT planning and coordination for process equipment, including schedule creation/maintenance and readiness tracking.
- Participation in change control, especially evaluating and communicating schedule and scope impacts of design/scope changes.
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