Principal Engineer (Automated Visual Inspection)

The Opportunity

You will provide direct support to the cross functional team of Engineering and Maintenance, Operations, CQV, Quality, and MS&T to improve the operations and quality of site's commercial cGMP AVI systems. You will report to the Sr. Manager, Engineering.

• Provide consulting support on technical issues related to equipment in Automated Visual Inspection, specifically, Seidenader and Brevetti automated syringe Inspection machines.
• Lead cross functional AVI team in seasonal campaign and project environments.
• Help develop a site-wide AVI management program for existing commercial AVI. This includes technical and regulatory inputs to the management of defect classification and kitting, technical complaint assessment, operator training, and AVI automation management.
• Directly partner with project delivery team(s) to develop and implement strategy for AVI in keeping with commercial growth forecasts and existing AVI obsoletion.
• Lead investigations into drug product technical product complaints and manufacturing deviations related to particulate or defect complaints.
• Provide oversite and guidance to visual inspection qualification and requalification activities to include quality and process improvements.
• Lead the team to use tools such as CMMS, Reliability Centered Maintenance (RCM), PM optimization (PMO), Root Cause Failure Analysis (RCFA), equipment history analysis, failure predictions and other to maximize AVI equipment reliability.
• Lead cross functional team to manage AVI operations with SOP development, operator training programs, campaign continuous improvements.
• Establish and prepare site AVI KPI data / dashboard ensuring focus on equipment performance.
• Provide mentoring and coaching for engineering or technical staff

Education

Bachelor's degree in engineering or related field required

Experience

Understanding of the principles of:

• Minimum 10+ years related experience with inspection and packaging engineering within a relevant industry.
• Manual, semi-automated, and automated visual inspection processes
• AVI and image analysis technologies
• Automation systems in cGMP environment
• Equipment Life Cycle Cost Analysis
• Root Cause Failure Analysis (RCFA) and Failure Mode and Effect Analysis (FMEA)
• Engineering design standards and their application
• Robust comprehension of relevant CFRs, cGMPs, regulatory and industry guidance for AVI
• Leadership, organizational planning, and project management skills, in addition to technical knowledge, is required to coordinate multi-disciplinary teams
• Demonstrated experience working in a matrix organization and indirectly leading others

Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.