Inspection Subject Matter Expert

Sanofi; Munster; On-site; EUR 90,000 - 120,000; Full time

Job summary

Sanofi Waterford seeks an Inspection Subject Matter Expert (SME) to provide technical authority over visual inspection processes for AVI and MVI, ensuring qualification, compliance, and optimization across Lyo and mAbs operations at the Waterford site.

Reporting to Product Supply APU, the role leads qualification lifecycles, training, defect library management, and regulatory readiness, maintaining 100% visual inspection in line with cGMP and HPRA/FDA/EMA expectations.

Qualifications

• Significant pharma experience focusing on inspection operations.
• Experience with regulatory inspections (HPRA, FDA, EMA) in an SME capacity.
• Background in defect management and 100% visual inspection requirements.
• Knowledge of qualification lifecycle for inspection systems and quality standards.

Responsibilities

• AVI System Management and site technical authority for AVI equipment across Lyo and mAbs areas.
• Lead full qualification lifecycle (URS, FRS, DQ, IQ, OQ, PQ, PPQ) of AVI systems.
• Establish and maintain tuning parameters and challenge set protocols.
• Manage equipment requalification, log books, and preventive maintenance programmes.
• Defect Set Creation & Management and maintenance of the Defect Master Library (DML).
• Train inspectors; qualify inspectors and maintain qualification records.
• Ensure compliance with FDA, EMA, HPRA, USP and other regulatory standards.

Skills

Inspection operations

Regulatory inspections

Quality systems

Education

Bachelor's degree in Engineering/Science/Pharmacy

Master's degree preferred

Professional certifications in inspection/quality

Job description

Job Title: Inspection Subject Matter Expert (SME)

• Location: Waterford, Ireland
• Job Type: Permanent, Full-Time
• Working Arrangements: On-site

About The Job

The Inspection SME serves as the primary technical authority for all visual inspection processes at Sanofi Waterford, spanning both Automated Vision Inspection (AVI) systems and Manual Visual Inspection (MVI). Reporting into the Product Supply APU as the process-owning function, this individual will provide expert oversight across the Lyo and mAbs operational areas, ensuring inspection processes are qualified, compliant, and continuously optimised in line with Sanofi global standards and applicable regulatory requirements.

The SME will be the site's technical lead for inspection system lifecycle management, from equipment qualification through to defect library management, inspector training, and baseline study execution, ensuring that all injectable products undergo 100% visual inspection in accordance with cGMP standards as required by the HPRA, FDA, and EMA.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• Automated Vision Inspection (AVI) System Management
• Serve as site technical authority for all AVI equipment across Lyo and mAbs areas
• Lead full qualification lifecycle (URS, FRS, DQ, IQ, OQ, PQ, PPQ) of AVI systems
• Establish and maintain tuning parameters and challenge set protocols
• Manage equipment requalification, log books, and preventive maintenance programmes
• Defect Set Creation & Management
• Create, update, and decommission defects and defect sets for vials, syringes, and container closure systems
• Maintain the site Defect Master Library (DML) aligned with FMEA outputs
• Oversee generation of Manual Inspection Sensitivity/Baseline Sets
• Manage defect classification (Critical, Major, Minor) per site procedures
• Manual Inspector Training & Qualification
• Design and deliver training programmes for manual inspectors
• Train on defect identification, classification, and regulatory inspection techniques
• Qualify inspectors and maintain qualification records
• Ensure compliance with regulatory standards (lighting, technique, duration)
• Baseline Study Supervision & Execution
• Supervise and execute manual baseline studies per site procedures
• Lead generation of Manual Inspection Sensitivity/Baseline Sets
• Apply statistical analysis to establish inspection performance benchmarks
• Generate and maintain FMEA documentation
• Regulatory Compliance & Technical Standards
• Ensure compliance with FDA, EMA, Ph Eur, USP, and JP inspection requirements
• Maintain current knowledge of evolving regulatory expectations
• Support regulatory inspections as site inspection SME
• Ensure 100% visual inspection of all injectable products
• Cross-Functional Collaboration
• Act as primary inspection technical liaison across Product Supply, Manufacturing, QA, and Engineering
• Collaborate with equipment suppliers during feasibility and qualification activities
• Support change control, deviation investigations, CAPAs, and continuous improvement initiatives

About You

• Significant experience in the pharmaceutical industry, with a significant focus on inspection operations
• Bachelor's degree in Engineering, Science, Pharmacy, or related technical discipline; Master's degree preferred; relevant professional certifications in inspection, quality systems, or pharmaceutical manufacturing advantageous
• Experience in lyophilisation and/or biologics (mAbs) manufacturing environments
• Familiarity with Sanofi inspection procedures and global quality standards
• Experience with defect library creation, management, and decommissioning processes
• Background in statistical analysis as applied to inspection baseline studies
• Project management experience, particularly in equipment qualification or inspection process improvement projects
• Experience supporting regulatory inspections (HPRA, FDA, EMA) in an SME capacity
• Must meet Sanofi SME visual qualification standards, including 20/20 vision (corrected acceptable), adequate depth perception, colour deficiency testing, annual eye examination, and the ability to perform detailed visual inspection tasks in a cleanroom/controlled manufacturing environment.

Why choose us?

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
• Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
• Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery.