01 ago
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Experteer Italy
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Lombardia
01 ago
Experteer Italy
Lombardia
Experteer 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.
Retribuzione / Benefits
- 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
Responsabilità
- 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
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📌 CQV Engineer (Lombardia)
🏢 Experteer Italy
📍 Lombardia