Senior Project Engineer

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Harba Solutions Inc. seeks a Senior Project Engineer to independently execute commissioning, qualification, validation, and related activities, while owning defined project scope and technical direction.

You will interact with clients and vendors, mentor junior engineers, and ensure adherence to industry guidelines such as ASTM E2500 and ISPE throughout projects.

Qualifications

• 7+ years in process engineering, commissioning, qualification, validation, or related roles.
• Bachelor’s degree in Engineering or related field.
• Experience independently managing equipment, systems and defined project scope.
• Strong understanding of commissioning, qualification, validation in regulated environments.
• Strong technical documentation, troubleshooting, and problem-solving skills.
• Effective communication with clients, vendors, contractors, and cross-functional teams.
• Experience mentoring or guiding junior engineers.

Responsibilities

• Develop and execute commissioning, qualification, and validation protocols with minimal supervision.
• Own equipment, systems and scope from execution through closeout.
• Prepare protocols, risk assessments, test plans, deviations, and summary reports.
• Document test results, investigate deviations, and support issue resolution.
• Coordinate activities with clients, vendors, contractors, and cross-functional teams.
• Contribute to project schedules, resource planning, and progress reporting.
• Identify issues early and develop corrective actions to maintain progress.
• Apply risk-based verification and ISPE/ASTM E2500 guidelines.

Skills

Project management

Client communication

Technical documentation

Troubleshooting

Mentoring

Risk-based verification

Regulatory compliance

Cross-functional coordination

Education

Bachelor's degree in Engineering

Job description

The Senior Project Engineer is an experienced engineering professional responsible for independently executing commissioning, qualification, validation, and process-related activities while managing defined project scope. This role requires strong technical ownership of systems and equipment, direct interaction with clients and vendors, and the ability to provide guidance to junior engineers.

Job Responsibilities

• Develop and execute commissioning, qualification, and validation protocols with minimal supervision.
• Take ownership of assigned equipment, systems and project scope from execution through closeout.
• Prepare technical and validation documentation including protocols, risk assessments, test plans, deviation documentation, and summary reports.
• Document test results, investigate deviations, and support resolution of technical issues.
• Coordinate engineering and qualification activities with clients, vendors, contractors, and cross-functional teams.
• Contribute to project schedules, resource planning, progress tracking, and reporting.
• Identify project or system issues proactively and develop solutions to maintain project progress.
• Apply risk-based verification and industry best practices, including ASTM E2500 and ISPE guidelines.
• Support internal, regulatory, and client audits as needed.
• Review technical work produced by junior engineers and provide feedback and guidance.
• Mentor junior team members and support technical training and knowledge transfer.
• Serve as a technical resource for commissioning, qualification, validation, and process engineering activities.

Job Qualifications

• 7+ years of experience in process engineering, commissioning, qualification, validation, or related engineering functions within pharmaceutical, biotech, chemical, or other regulated manufacturing industries.
• Bachelor’s degree in Engineering or a related scientific discipline.
• Demonstrated experience independently managing equipment, systems and defined project scope.
• Strong understanding of commissioning, qualification, validation, and regulated manufacturing environments.
• Strong technical documentation, troubleshooting, and problem-solving skills.
• Ability to communicate effectively with clients, vendors, contractors, and cross-functional project teams.
• Experience mentoring or providing technical guidance to junior engineers.