Jobs / United States / Sanofi US Services INC
Inspection Subject Matter Expert
Sanofi US Services INC · 🇺🇸 Waterford
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 47 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 29 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Sanofi US Services INC paid sponsored hires in similar roles2 certified filings for “Case Management and Process Expert” (Data Scientists) in NJ: $170k–$170k, median $170k. Most were filed at wage level IV (100%) — 4 lottery entries, ≈61% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Last confirmed live 2 days agoWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Sanofi US Services INC
The US Department of Labor certified 47 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 29 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Sanofi US Services INC →
About the role
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. Ready to get started? Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. 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: 1. 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 2. 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 3. 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) 4. 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 5. 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 6. 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