Principal, Visual Inspection Program Lead

The Opportunity

You will provide direct support and leadership to the cross functional team (Engineering and Maintenance, Operations, CQV, Quality, and MS&T) supporting the site Visual Inspection (VI) program. Improving the operations and quality of site's commercial and project cGMP VI systems. This role will define the strategy for both implementation of new and improvement of existing VI operations. You will report to the Sr. Manager, Engineering. This position is located at our facility in Holly Springs, NC.

• Directly partner with project delivery team(s) to develop and implement program strategy for automated, semi-automated and manual visual inspection (VI) in keeping with commercial growth forecasts and existing VI equipment obsolescence. Identify and lead adoption of new / emerging technologies to support this strategy.
• Lead strategic approach to visual inspection qualification and requalification activities to include quality and process improvements and ensure compliance with industry expectations.
• Lead improvements of site-wide VI management program for existing commercial Automated VI systems. This includes technical and regulatory inputs to the management of defect classification and kitting, technical complaint assessment, operator training, and AVI automation management.
• Lead cross functional team to support AVI operations with SOP development, operator training programs, campaign continuous improvements.
• Provide consulting support on technical issues related to equipment in Automated Visual Inspection, specifically, Seidenader and Brevetti automated syringe Inspection machines in seasonal campaign and project environments.
• Provide technical support to investigations into drug product technical product complaints and manufacturing deviations related to particulate or defect complaints, both at the site and CMOs.
• 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.
• Establish and prepare site VI 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

• Minimum 10+ years related experience with inspection and packaging engineering within a relevant industry.
• Demonstrated experience working in a matrix organization and indirectly leading others

Understanding of the principles of:

• Manual, semi-automated, and automated visual inspection processes including image analysis technologies
• Automation systems in cGMP environment
• Leadership, organizational planning, and project management skills, in addition to technical knowledge, is required to coordinate multi-disciplinary teams
• 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

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.

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.