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. This role requires deep technical expertise in machine vision technology, pharmaceutical validation (IQ/OQ/PQ), and defect troubleshooting to ensure that inspection equipment meets stringent regulatory and quality standards prior to its 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 proficiency required; Swedish language skills are a bonus.
Interested? Apply online using the form below. Note that only applications matching the job profile will be considered.
Work locationWestern Europe, Sweden, Switzerland