Lead Inspection SME - AVI & MVI Systems Expert

Sanofi; Munster; On-site; EUR 70,000 - 100,000; Full time

Job summary

Sanofi Waterford seeks an Inspection Subject Matter Expert (SME) to serve as the site technical authority for all visual inspection processes, covering AVI and MVI systems across Lyo and mAbs operations. You will ensure qualification, compliance with cGMP and regulatory standards (HPRA, FDA, EMA), and lead lifecycle management from qualification through defect libraries and training.

The role requires deep QA/inspection expertise, capability to design and supervise baseline studies, and ongoing

Qualifications

• Bachelor's degree in engineering/science/pharmacy or related field. Master’s degree preferred; professional certifications in inspection/quality systems are advantageous.
• Experience in lyophilisation and/or biologics (mAbs) manufacturing environments.
• Experience supporting regulatory inspections (HPRA, FDA, EMA) in an SME capacity.

Responsibilities

• Oversee Automated Vision Inspection (AVI) system management and qualification lifecycle (URS, FRS, DQ, IQ, OQ, PQ, PPQ).
• Lead defect library creation, management, and decommissioning for vials, syringes, and closures.
• Train and qualify manual inspectors; ensure compliance with regulatory inspection techniques.
• Supervise manual baseline studies and generate inspection performance benchmarks.
• Collaborate cross-functionally with Product Supply, Manufacturing, QA, and Engineering.

Skills

Inspection operations

Lyophilisation

Statistical analysis

Project management

Regulatory inspections

Visual inspection standards

Defect management

Training & coaching

Education

Bachelor's degree in Engineering, Science, Pharmacy, or related technical discipline

Master's degree preferred

Certifications in inspection/quality systems advantageous

Job description

Sanofi Waterford seeks an Inspection Subject Matter Expert (SME) to serve as the site technical authority for all visual inspection processes, covering AVI and MVI systems across Lyo and mAbs operations. You will ensure qualification, compliance with cGMP and regulatory standards (HPRA, FDA, EMA), and lead lifecycle management from qualification through defect libraries and training.

The role requires deep QA/inspection expertise, capability to design and supervise baseline studies, and ongoing