Inspection Subject Matter Expert (Pharmaceutical Manufacturing)

Location: Waterford, Ireland; on-site

Salary: €73,200–€97,600 per year

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.

What you will do

• Act as the site technical authority for automated vision inspection equipment across lyophilisation and monoclonal antibody manufacturing areas.
• Lead the full qualification lifecycle for inspection systems, including URS, FRS, DQ, IQ, OQ, PQ, and PPQ.
• Create, maintain, and decommission defect sets and the site Defect Master Library for vials, syringes, and container closure systems.
• Design and deliver manual inspector training, qualification, and ongoing records management.
• Supervise baseline studies, apply statistical analysis, and maintain FMEA documentation.
• Support regulatory inspections, change controls, deviation investigations, CAPAs, supplier activities, and continuous improvement.

Requirements

• Significant pharmaceutical industry experience focused on inspection operations.
• Bachelor’s degree in Engineering, Science, Pharmacy, or a related technical discipline; a Master’s degree is preferred.
• Experience in lyophilisation and/or biologics manufacturing environments.
• Experience managing defect libraries, inspection baseline studies, statistical analysis, and equipment qualification projects.
• Experience supporting HPRA, FDA, and EMA regulatory inspections in an SME capacity.
• Must meet visual qualification requirements, including 20/20 vision, adequate depth perception, colour deficiency testing, annual eye examinations, and the ability to perform detailed cleanroom inspection tasks.

Culture & Benefits

• Work in a global manufacturing and supply organisation delivering medicines and vaccines.
• Opportunities to develop new skills and explore cross-functional roles.
• Work on product launches intended to improve treatment access and delivery.
• Participate in a workplace focused on growth, discovery, inclusion, and equal opportunity.