AVI Expert - Sweden

Lead and Support Advanced AVI System Validation

Bring deep technical expertise in machine vision technology, pharmaceutical validation, and defect troubleshooting to ensure inspection equipment meets stringent regulatory and quality standards ahead of full commercial release. This role involves leading and supporting the Performance Qualification, validation, and optimization of an advanced Italian-engineered Automated Visual Inspection system.

Validation & Qualification

• 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, including defect kits for cracked vials, black spots, particulate matter, and fill-level variations, to evaluate system sensitivity and reliability.
• Perform statistical analysis on inspection data, such as Probability of Detection, False Rejection Rate, and 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 and accept trends and implement CAPAs to improve overall equipment effectiveness.
• Provide hands-on support during FAT, SAT, and commissioning phases.

Required Qualifications

• 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.