Principal MS&T AVI Engineer

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.

Job Qualifications:

• 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.