Project Engineer

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Harba Solutions Inc. is seeking a Project Engineer to independently execute commissioning and qualification activities, managing defined project scope and delivering compliant, client-ready results.

You will mentor junior staff, review documents, coordinate with vendors, and help shape schedules and reporting while applying ASTM E2500 and ISPE guidelines.

Qualifications

• 5+ years of experience in commissioning, qualification, or validation (pharma, biotech, chemical, or related industries).
• Bachelor’s degree in Engineering or related technical field.
• Strong documentation and organizational skills.
• Effective communicator with clients, vendors, and teams.

Responsibilities

• Develop and execute commissioning and qualification protocols with minimal supervision.
• Take ownership of assigned systems or equipment within the project.
• Document test results, deviations, and resolutions with accuracy and compliance.
• Prepare validation deliverables such as risk assessments, test plans, and summary reports.
• Review and provide feedback on documentation produced by junior-level engineering staff.
• Ensure all documents are compliant, audit-ready, and aligned with regulatory standards.
• Coordinate system-level commissioning & qualification activities with vendors, contractors, and clients.
• Contribute to project schedules, resource planning, and reporting.
• Escalate issues proactively and propose solutions to maintain progress.
• Apply risk-based verification and industry best practices (e.g., ASTM E2500, ISPE guidelines).
• Ensure execution complies with GMP, FDA, and client requirements.
• Mentor and provide guidance to junior-level team members.
• Contribute to knowledge transfer and training within the project team.
• Independently solve problems and execute technical work.
• Balance multiple priorities within project timelines.
• Contribute emerging leadership skills, including mentoring junior staff.

Skills

Documentation

Organization

Communication

Education

Bachelor’s degree in Engineering or related field

Job description

The Project Engineer is a mid-level engineering role responsible for independently executing commissioning and qualification activities while managing defined project scope. The Project Engineer ensures deliverables meet regulatory and client expectations while supporting project progress and team development.

Job Responsibilities

• Develop and execute commissioning and qualification protocols with minimal supervision.
• Take ownership of assigned systems or equipment within the project.
• Document test results, deviations, and resolutions with accuracy and compliance.
• Prepare validation deliverables such as risk assessments, test plans, and summary reports.
• Review and provide feedback on documentation produced by junior-level engineering staff.
• Ensure all documents are compliant, audit-ready, and aligned with regulatory standards.
• Coordinate system-level commissionig & qualification activities with vendors, contractors, and clients.
• Contribute to project schedules, resource planning, and reporting.
• Escalate issues proactively and propose solutions to maintain progress.
• Apply risk-based verification and industry best practices (e.g., ASTM E2500, ISPE guidelines).
• Ensure execution complies with GMP, FDA, and client requirements.
• Mentor and provide guidance to junior-level team members.
• Contribute to knowledge transfer and training within the project team.
• Independently solve problems and execute technical work.
• Balance multiple priorities within project timelines.
• Contribute emerging leadership skills, including mentoring junior staff.

Job Qualifications

• 5+ years of experience in commissioning, qualification, or validation (pharma, biotech, chemical, or related industries).
• Bachelor’s degree in Engineering or related technical field.
• Strong documentation and organizational skills.
• Effective communicator with clients, vendors, and teams.