Project Engineer

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 90,000 - 115,000; Full time

Job summary

Harba Solutions Inc. in Indianapolis is seeking a Project Engineer to support commissioning, qualification, and startup activities within a pilot plant pharmaceutical manufacturing environment.

You will work closely with experienced engineers and project teams to execute testing, support equipment and facility qualification, and maintain compliant project documentation. The role provides hands-on exposure to GMP systems, validation lifecycle activities, and capital project execution, helping you

Qualifications

• Bachelor's degree in Engineering is required.
• 5+ years of engineering experience in commissioning and qualification.
• Knowledge of GMP, validation lifecycle.

Responsibilities

• Support execution of commissioning and qualification activities for manufacturing equipment, utilities, facilities, and process systems.
• Assist with field verification, equipment startup, testing, and protocol execution activities under the guidance of senior engineers.
• Document test results, observations, discrepancies, and execution outcomes in accordance with project and regulatory requirements.
• Support preparation, review, and completion of commissioning and qualification documentation, including test protocols, turnover packages, and summary reports.
• Collaborate with engineering, quality, operations, maintenance, and vendor teams to support project objectives and execution schedules.
• Participate in troubleshooting activities and assist with the resolution of technical issues identified during testing and startup.
• Support deviation investigations, change controls, corrective actions, and other quality-related activities as required.
• Maintain organized, accurate, and audit-ready documentation throughout project execution.
• Follow established GMP, safety, and compliance requirements while supporting commissioning and qualification activities.
• Participate in project meetings, provide updates on assigned tasks, and communicate project risks or delays when appropriate.
• Develop knowledge of industry standards, validation methodologies, and regulated manufacturing systems through training and hands-on project experience.

Skills

GMP understanding

Qualification testing

Documentation

Project coordination

Education

Bachelor's degree in Engineering

Job description

The Project Engineer is an engineering position supporting commissioning, qualification, and startup activities within a pilot plant pharmaceutical manufacturing environment. This role works closely with experienced engineers and project teams to execute testing activities, support equipment and facility qualification, and maintain compliant project documentation. The position provides hands-on exposure to GMP manufacturing systems, validation lifecycle activities, and capital project execution while developing technical, compliance, and project management skills.

Job Responsibilities

• Support execution of commissioning and qualification activities for manufacturing equipment, utilities, facilities, and process systems.
• Assist with field verification, equipment startup, testing, and protocol execution activities under the guidance of senior engineers.
• Document test results, observations, discrepancies, and execution outcomes in accordance with project and regulatory requirements.
• Support preparation, review, and completion of commissioning and qualification documentation, including test protocols, turnover packages, and summary reports.
• Collaborate with engineering, quality, operations, maintenance, and vendor teams to support project objectives and execution schedules.
• Participate in troubleshooting activities and assist with the resolution of technical issues identified during testing and startup.
• Support deviation investigations, change controls, corrective actions, and other quality-related activities as required.
• Maintain organized, accurate, and audit-ready documentation throughout project execution.
• Follow established GMP, safety, and compliance requirements while supporting commissioning and qualification activities.
• Participate in project meetings, provide updates on assigned tasks, and communicate project risks or delays when appropriate.
• Develop knowledge of industry standards, validation methodologies, and regulated manufacturing systems through training and hands-on project experience.

Job Qualifications

• Bachelor's degree in Engineering or a related technical discipline required.
• 5+ years of engineering experience in commissioning and qualification, validation, manufacturing, facilities, utilities and related technical environments.