Senior CapEx Project Engineer – GMP Manufacturing

Forge Biologics; Columbus (OH); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Parental leave

401(k) with company match

Annual bonus

Onsite fitness center

Mentorship programs

Paid time off

Job summary

Forge Biologics in Columbus, Ohio is seeking a Sr. Project Engineer to lead CapEx projects from feasibility through start-up. You will own schedules and budgets, deliver critical engineering documents, and drive governance with internal PMO and external partners.

This role requires 7+ years in project engineering, a engineering degree, and experience in GMP/FDA environments. You’ll collaborate across disciplines, manage vendor relations, and ensure safe, compliant delivery at The Hearth site.

Responsibilities

• Supports mid-large scale CapEx projects from feasibility through start-up, ensuring alignment with site CapEx and Site Master Planning strategies.
• Serve as the engineering SME on complex projects, partnering with the Internal PMO and preparing governance documentation for major initiatives.
• Develops and maintains Project Charters, Project Execution Plans (PEPs), Scope of Work (SOW) documents, User Requirements Documents and other critical project documents, ensuring compliance with engineering standards.
• Establishes NDAs and negotiates appropriate engineering/design-build contracts in coordination with Finance and Contracts.
• Prepares and maintains engineering project schedules and cost estimates (ROM).
• Leads project meetings to communicate status, timelines, and budget updates.
• Partners with design-build firms to define scope, budgets, and timelines; leads RFP processes and ETOP requirements.
• Provide field oversight of construction activities, ensuring quality, safety, permitting compliance, and timely resolution of project issues.
• Follows PCO and ECN processes to manage scope, financial, and design changes.
• Conducts or supports Technical Design Reviews (TDRs) and risk assessments (dfMEA, PHA, PSSR).
• Drives project quality and change control activities to closure in compliance with site standards.
• Manages relationships with vendors; seeks new partners to support project execution and continuous improvement.
• Coordinate with Plant Engineering and Maintenance to support CMMS asset configuration, maintenance planning, and FAT/SAT processes.

Job description

Forge Biologics in Columbus, Ohio is seeking a Sr. Project Engineer to lead CapEx projects from feasibility through start-up. You will own schedules and budgets, deliver critical engineering documents, and drive governance with internal PMO and external partners.

This role requires 7+ years in project engineering, a engineering degree, and experience in GMP/FDA environments. You’ll collaborate across disciplines, manage vendor relations, and ensure safe, compliant delivery at The Hearth site.