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Forge Biologics is seeking a Senior Project Engineer to lead capital expenditure (CapEx) projects at their state-of-the-art 200,000-square-foot cGMP manufacturing facility in Columbus, Ohio. The facility specializes in AAV (adeno-associated virus) manufacturing for gene therapy applications.
In this role, you will manage mid-to-large scale CapEx projects from feasibility and conceptualization through detailed engineering, construction, and start-up. You'll serve as the engineering subject matter expert on complex initiatives, partnering with the internal PMO and preparing governance documentation for major projects.
Key responsibilities include developing and maintaining project charters, execution plans, scope of work documents, and user requirement specifications. You'll establish NDAs and negotiate engineering/design-build contracts in coordination with Finance and Contracts teams. You'll prepare project schedules and cost estimates (ROM), lead project meetings to communicate status and budget updates, and partner with design-build firms to define scope and timelines through competitive RFP processes.
Field oversight is critical: you'll ensure construction quality, safety, permitting compliance, and timely resolution of issues. You'll manage change control processes (PCO and ECN), conduct technical design reviews and risk assessments (dFMEA, PHA, PSSR), and coordinate with Plant Engineering and Maintenance on CMMS asset configuration, maintenance planning, and FAT/SAT processes.
You'll manage vendor relationships, drive continuous improvement, and ensure all documentation is properly incorporated into the engineering document management system (EDMS). Finally, you'll lead or support project closure and turnover documentation to ensure operational readiness.
Required qualifications: 7+ years of project engineering, facilities, or capital project development experience; Bachelor's degree in Mechanical, Chemical, Electrical, or related Engineering field; experience in highly regulated industries (GMP, FDA); strong project budgeting and cost tracking skills; cross-departmental collaboration experience; proficiency in Microsoft Office, MS Project, AutoCAD, and engineering document management systems.
