Biologics Project Engineer: Design–Startup for GMP Success

Abzena; Bristol Township (Bucks County); On-site; USD 90,000 - 130,000; Full time

Job summary

Abzena is seeking a Project Engineer to plan and execute site capital projects, equipment installations, facility upgrades, and engineering improvements supporting operations. You will collaborate with Manufacturing, Facilities, QA, Validation, EHS, Supply Chain, and vendors to deliver safe, compliant, and cost-effective solutions.

Responsibilities span from scope definition through startup, qualification, and turnover, with emphasis on risk-based strategies, change control, and timely project

Qualifications

• Bachelor's degree in an engineering discipline is required.
• Experience in project engineering, capital projects, or facilities engineering in regulated manufacturing.
• Knowledge of cGMP, GMP, data integrity and documentation practices.
• Experience with FAT, IQ/OQ, risk-based qualification approaches.
• Experience managing budgets, schedules, and vendors.
• Strong written and oral communication for cross-functional collaboration.

Responsibilities

• Lead capital and expense projects from concept to turnover.
• Develop charters, scopes, estimates, schedules and risk registers.
• Own scope, schedule, budget forecasts, and change management.
• Coordinate cross-functional project teams and drive accountability.
• Lead design reviews, evaluations, and vendor selections.
• Prepare technical drawings, P&IDs, and vendor documentation.
• Manage external firms and contractors to meet GMP and safety standards.
• Plan FAT, SAT, IQ/OQ activities and qualifications.
• Define commissioning strategies with Validation and Quality.
• Ensure complete project turnover with as-built docs and asset records.

Skills

Strong communication

Stakeholder management

Project management

Analytical thinking

Structured problem-solving

Technical writing

Microsoft Office proficiency

Project controls

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Chemical Engineering

Bachelor's degree in Electrical Engineering

Bachelor's degree in Industrial Engineering

Bachelor's degree in Biomedical Engineering

Tools

CMMS

ERP

Document management systems

Microsoft Office

Job description

Abzena is seeking a Project Engineer to plan and execute site capital projects, equipment installations, facility upgrades, and engineering improvements supporting operations. You will collaborate with Manufacturing, Facilities, QA, Validation, EHS, Supply Chain, and vendors to deliver safe, compliant, and cost-effective solutions.

Responsibilities span from scope definition through startup, qualification, and turnover, with emphasis on risk-based strategies, change control, and timely project