🛠 Tech Stack

💼 About This Role

You'll join CAI's growing Italy operations to develop and execute commissioning, qualification, and validation documentation for pharmaceutical facilities. You'll support protocol writing and field verification at client sites, ensuring cGMP compliance. This role offers hands-on experience with cutting-edge life sciences projects across Europe.

🎯 What You'll Do

• Write and execute qualification protocols (IQ/OQ/PQ)
• Perform field walkdowns and troubleshooting of equipment
• Develop summary reports and manage C&Q documentation lifecycle
• Support FATs, SATs, and system start-up activities

📋 Requirements

• BS or MS in relevant science or engineering field
• 4-8 years of C&Q experience in FDA regulated industry
• Knowledge of pharmaceutical utilities (WFI, RO, HVAC) and processes
• English fluency and availability for travel in Italy and Europe

✨ Nice to Have

• Experience with isolators qualification and VHP cycle development
• Familiarity with Baseline Guide 5 (Second Edition)

🎁 Benefits & Perks

• 🌍 European travel opportunities across Italy and Europe
• 📚 Professional development in a growing global company
• 🤝 Collaborative team with cGMP leadership guidance

🚩 Heads Up

• Requires EU citizenship or valid residence permit
• Broad responsibility range from execution to strategy