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. 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. Defect Set Creation 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. #J-18808-Ljbffr
Inspection Subject Matter Expert employer: Sanofi Inc.
Sanofi is an exceptional employer that fosters a culture of innovation and inclusivity, making it an ideal place for a Senior Tax Accountant to thrive. Located in Reading, UK, employees benefit from a supportive work environment that prioritises professional growth and offers a comprehensive rewards package, including extensive health and wellbeing benefits. With a commitment to diversity and a focus on meaningful contributions, Sanofi empowers its team members to make a real impact in the biopharma industry.
