Commissioning Engineer
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-08-29
Listing for:
Harba Solutions Inc.
Full Time
position Listed on 2026-08-29
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
- 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
- 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
- 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
- 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
- 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)
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