Beschreibung

Automated Visual Inspection (AVI) Validation Expert Location: Sweden (onsite/hybrid) Contract: 6 months Start Date: 2026 About the Role We are seeking an experienced Automated Visual Inspection (AVI) Expert to lead and support the Performance Qualification (PQ), validation, and optimization of an advanced Italian-engineered AVI system. You'll bring deep technical expertise in machine vision technology, pharmaceutical validation (IQ/OQ/PQ), and defect troubleshooting to ensure the inspection equipment meets stringent regulatory and quality standards ahead of full commercial release. Key Responsibilities Validation & Qualification (PQ) Author, review and execute Performance Qualification protocols, test plans and summary reports in compliance with cGMP, GAMP 5 and EU Annex 1 Design and execute challenge test sets (defect kits including cracked vials, black spots, particulate matter, fill-level variations) to evaluate system sensitivity and reliability Perform statistical analysis on inspection data (Probability of Detection, False Rejection Rate, False Acceptance Rate) to prove system robustness System Setup & Optimization Configure and calibrate camera systems, lighting parameters and optics to optimize defect detection across container formats Collaborate with the OEM and internal automation teams to fine-tune image processing algorithms and machine learning models Troubleshooting & Defect Management Investigate and troubleshoot technical issues related to mechanical handling, camera synchronization and software rejection logic Analyze false reject/accept trends and implement CAPAs to improve overall equipment effectiveness (OEE) Provide hands-on support during FAT, SAT and commissioning phases What We're Looking For Strong technical background in machine vision technology and automated visual inspection systems Proven experience with pharmaceutical validation (IQ/OQ/PQ), ideally within AVI or similar automated inspection equipment Familiarity with cGMP, GAMP 5 and EU Annex 1 requirements Experience with FAT/SAT and commissioning of complex automated equipment Strong analytical and troubleshooting skills English required; Swedish is a bonus Interested?