GMP Project Engineer-Biotech Facilities & Capital Projects

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 85,000 - 125,000; Full time

Job summary

Abzena Inc. is seeking a Project Engineer to plan and execute site capital projects, equipment installations, and facility upgrades that support manufacturing operations.

You will work cross-functionally with Manufacturing, Facilities, QA, Validation, EHS, Supply Chain, and IT to deliver safe, compliant, and cost-effective solutions from scoping through turnover. The role emphasizes managing scope, schedule, budget, and risk, developing charters and plans, coordinating vendors, and ensuring GMP

Qualifications

• Bachelor's degree in Mechanical, Chemical, Electrical, Industrial, Biomedical, or related engineering.
• At least 3 years in project engineering or capital project execution in regulated manufacturing.
• Experience through design to turnover (design, procurement, commissioning, qualification, startup).
• Knowledge of cGMP, Good Engineering Practices, data integrity, and pharmaceutical quality systems.
• Experience with FAT, SAT, IQ, OQ, and risk-based qualification approaches.
• Strong writing, analytical, and stakeholder management skills.
• Experience with CDMO or biologics manufacturing preferred.

Responsibilities

• Manage capital and expense projects from concept to closeout.
• Develop charters, scopes of work, and project plans.
• Own scope, schedule, budget, and change management for assigned projects.
• Coordinate multidisciplinary project teams and external vendors.
• Lead design reviews and vendor evaluation.
• Define risk-based commissioning and qualification strategies.
• Ensure GMP compliance and proper documentation at turnover.
• Prepare dashboards and KPIs for safety and readiness.
• Support annual capital planning and project prioritization.
• Integrate EHS requirements into project design and execution.

Skills

Project management

Cross-functional collaboration

Technical writing

Analytical thinking

Problem solving

Stakeholder management

Education

Bachelor's degree in Mechanical Engineering

Tools

CMMS

ERP

MS Office

Project controls software

Job description

Abzena Inc. is seeking a Project Engineer to plan and execute site capital projects, equipment installations, and facility upgrades that support manufacturing operations.

You will work cross-functionally with Manufacturing, Facilities, QA, Validation, EHS, Supply Chain, and IT to deliver safe, compliant, and cost-effective solutions from scoping through turnover. The role emphasizes managing scope, schedule, budget, and risk, developing charters and plans, coordinating vendors, and ensuring GMP