Overview
As a CQV Engineer in CAI Italy, you will develop and execute commissioning, qualification, and validation documentation for pharmaceutical facilities and equipment. You'll write protocols, perform field verifications, and prepare summary reports at client sites. You will lead CQV activities across the lifecycle, from SLIA generation to OQ completion, supporting FATs, SATs, IOQ and PQ executions. Join a bold, innovation-driven team that blends wisdom, technology, and humanity to advance operational readiness in life sciences.
Responsabilità
Support documentation for commissioning, qualification, and validation of facilities, utilities, and equipment
Lead protocol writing and field verification
Develop summary reports at client sites
Manage CQV lifecycle from SLIA generation to OQ completion
Support onsite and offsite activities: FATs, SATs, IOQ and PQ executions and system walkdowns
Apply knowledge of life science manufacturing processes and equipment
Provide cGMP leadership for CQV services delivery




Utilize Word/Excel for documentation and reporting
Requisiti fondamentali
BS or MS in a relevant science or engineering field, or equivalent hands-on experience
Minimum 2–3 years' experience in commissioning and/or qualification in an FDA regulated industry
Knowledge of facilities and equipment startup, walk downs, utilities (WFI, RO, HVAC), and manufacturing processes
Experience with FAT/SAT, URS, design review, P&IDs;, IQ/OQ/PQ, and related documentation
Strong problem-solving and troubleshooting skills
Ability to work independently and build a project team
Travel availability within Italy and abroad
Proficiency in Microsoft Word and Excel
Excellent oral and written English
high attention to detail
multi-tasking and initiative
independence with team-building
CQV services in Life Sciences
FDA regulated industry experience
WFI, RO, HVAC utilities knowledge

📌 Cqv Engineer (Bologna)
🏢 Cai
📍 Bologna