Inspection Subject Matter Expert

Sanofi Inc.; Waterford; On-site; GBP 77,000 - 103,000; Full time

Job summary

Sanofi Waterford is seeking an Inspection Subject Matter Expert (SME) to serve as the technical authority for all visual inspection processes across AVI and MVI. You will lead qualification lifecycle, maintain defect libraries, and train inspectors to ensure 100% visual inspection of injectable products in line with regulatory standards.

Based at on-site Waterford, you will collaborate with Product Supply, Manufacturing, QA and Engineering, drive continuous improvement, support regulatory

Qualifications

• Significant experience in pharmaceutical inspection operations.
• Bachelor's degree in a technical field; a Master's is preferred.
• Experience with lyophilisation or biologics (mAbs) advantageous.
• Familiarity with regulatory inspection processes and global quality standards.
• Ability to manage qualification lifecycles and defect libraries.

Responsibilities

• Lead AVI system qualification lifecycle (URS/FRS, DQ, IQ, OQ, PQ, PPQ).
• Create/update/decommission defects and manage the Defect Master Library (DML).
• Design and deliver training for manual inspectors and maintain qualification records.
• Supervise manual baseline studies and apply statistical analysis for performance benchmarks.
• Ensure 100% visual inspection of all injectable products per FDA/EMA/HPRA expectations.
• Collaborate across Product Supply, Manufacturing, QA and Engineering.

Skills

Inspection operations

Project management

Statistical analysis

Cross-functional collaboration

Regulatory inspections

Education

Bachelor's degree in Engineering/Science/Pharmacy

Master's degree preferred

Certifications in inspection/quality systems (advantageous)

Tools

AVI systems

Defect library management

Statistical analysis software

Job description

Job Title: Inspection Subject Matter Expert (SME)Location: Waterford, IrelandJob Type: Permanent, Full-TimeWorking 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.

Main responsibilities:

1. 1. Automated Vision Inspection (AVI) System ManagementServe as site technical authority for all AVI equipment across Lyo and mAbs areasLead full qualification lifecycle (URS, FRS, DQ, IQ, OQ, PQ, PPQ) of AVI systemsEstablish and maintain tuning parameters and challenge set protocolsManage equipment requalification, log books, and preventive
   maintenance programmes
2. 2. Defect Set Creation & ManagementCreate, update, and decommission defects and defect sets for vials, syringes, and container closure systemsMaintain the site Defect Master Library (DML) aligned with FMEA outputsOversee generation of Manual Inspection Sensitivity/Baseline SetsManage defect classification (Critical, Major, Minor) per site procedures
3. 3. Manual Inspector Training & QualificationDesign and deliver training programmes for manual inspectorsTrain on defect identification, classification, and regulatory inspection techniquesQualify inspectors and maintain qualification recordsEnsure compliance with regulatory standards (lighting, technique, duration)
4. 4. Baseline Study Supervision & ExecutionSupervise and execute manual baseline studies per site proceduresLead generation of Manual Inspection Sensitivity/Baseline SetsApply statistical analysis to establish inspection performance benchmarksGenerate and maintain FMEA documentation
5. 5. Regulatory Compliance &
   Technical StandardsEnsure compliance with FDA, EMA, Ph Eur, USP, and JP inspection requirementsMaintain current knowledge of evolving regulatory expectationsSupport regulatory inspections as site inspection SMEEnsure 100% visual inspection of all injectable products
6. 6. Cross-Functional CollaborationAct as primary inspection technical liaison across Product Supply, Manufacturing, QA, and EngineeringCollaborate with equipment suppliers during feasibility and qualification activitiesSupport 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.