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Principal MS&T AVI Engineer
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-02-21
Listing for:
Harba Solutions Limited
Full Time
position Listed on 2026-02-21
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Job Responsibilities
- Develop and implement automated inspection systems (AVI) inspection strategies for sterile autoinjectors.
- Act as the technical authority for inspection processes, systems, and quality standards, providing guidance across manufacturing and quality teams.
- Perform root cause investigations for inspection-related quality events and lead corrective and preventive actions.
- Partner with process engineering, manufacturing, and quality functions to drive continuous improvement initiatives and inspection system optimization.
- Maintain compliance with global regulatory expectations by ensuring inspection processes, procedures, and documentation meet current standards.
- Create and maintain internal technical and execution documentation supporting inspection lifecycle activities.
- Support regulatory inspections and internal audits as a subject matter expert.
- Assess emerging inspection technologies and methodologies to improve detection capability and operational efficiency.
- Bachelor’s degree in Engineering, Chemistry, or a related technical discipline; advanced degree preferred.
- 10+ years of experience in a GMP-regulated manufacturing environment.
- 5+ years of experience in inspection of sterile injectable products or combination products.
- Strong knowledge of inspection standards, defect classification, and inspection equipment (manual and automated).
- Experience interacting with regulatory agencies and supporting inspections.
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