Commissioning Engineer

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

Job summary

Harba Solutions Inc. seeks a qualified Validation professional to develop and execute C&Q protocols, owning systems within projects and ensuring accurate documentation of results and deviations.

You will review junior staff work, ensure audit-ready documentation aligned with GMP, FDA, and ISPE guidelines, and coordinate with vendors and clients to keep project progress on track.

Qualifications

• 2–5 years in commissioning, qualification, or validation in pharma/biotech.
• Bachelor's degree in Engineering or related technical field.
• Ability to manage assigned systems or project scope independently.
• Familiarity with GMP, FDA, and ISPE guidance.
• Experience with validation and project management tools such as Kneat or Smartsheet.

Responsibilities

• Develop and execute C&Q protocols with minimal supervision.
• Take ownership of assigned systems or equipment within the project.
• Document test results, deviations, and resolutions with accuracy and compliance.
• Coordinate system-level C&Q activities with vendors, contractors, and clients.
• Contribute to project schedules, resource planning, and reporting.
• Escalate issues proactively and propose solutions to maintain progress.
• Mentor and provide guidance to junior staff and support knowledge transfer.

Skills

Independent ownership

Regulatory familiarity

Documentation accuracy

Education

Bachelor's degree in Engineering or related field

Tools

Kneat

Smartsheet

Job description

• Develop and execute C&Q (Commissioning & 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

Technical Documentation

• Prepare validation deliverables such as risk assessments, test plans, and summary reports
• Review and provide feedback on documentation produced by junior (Engineer I level) staff
• Ensure all documents are compliant, audit-ready, and aligned with regulatory standards

Project Support & Coordination

• Coordinate system-level C&Q activities with vendors, contractors, and clients
• Contribute to project schedules, resource planning, and reporting
• Escalate issues proactively and propose solutions to maintain progress

Compliance & Quality

• Apply risk-based verification and industry best practices (e.g., ASTM E2500, ISPE guidelines)
• Ensure execution complies with GMP, FDA, and client requirements
• Support internal and client audits as required
• Mentor and provide guidance to junior (Engineer I level) team members
• Contribute to knowledge transfer and training within the project team

Required Qualifications

• 2–5 years of experience in commissioning, qualification, or validation (pharma, biotech, chemical, or related industries)
• Bachelor's degree in Engineering or related technical field
• Demonstrated ability to manage assigned systems or project scope independently
• Familiarity with GMP, FDA, and industry guidelines (ASTM E2500, ISPE)
• Proficiency with validation and project management tools (e.g., Kneat, Smartsheet)