19 set - Milano
Cai
Overview
As a CQV Engineer in Italy, you will develop and execute documentation for commissioning, qualification, and validation of facilities, utilities, and equipment. You will write protocols, perform field verifications, and craft summary reports at client sites, supporting cGMP-compliant CQV services. You’ll lead the CQV documentation lifecycle from SLIA generation to OQ completion and collaborate with cross-functional teams to deliver validated systems. This role offers hands-on problem solving in a regulated life sciences environment with global travel. You will help ensure reliable, compliant startup and operation of critical manufacturing assets.
Responsabilità
- Support CQV documentation for commissioning, qualification, and validation activities
- Write and execute protocols and perform field verifications
- Develop summary reports at client sites
- Manage CQV lifecycle from SLIA generation to OQ completion
- Support on-site and off-site activities including FATs, SATs, IOQ and PQ executions and system walkdowns
- Provide cGMP leadership for CQV services delivery
- Work with life sciences processes and equipment startup, walkdowns, and troubleshooting
- Assist with design reviews,
URS, P&IDs;, and IQ/OQ/PQ documentation and execution
Requisiti fondamentali
- BS or MS in a relevant science or engineering field, or equivalent experience
- 4–8 years’ experience in commissioning/qualification in an FDA-regulated industry
- Experience with facilities and equipment startup, walkdowns, utilities (WFI, RO, HVAC), FAT/SAT, URS, design review, P&IDs;, IQ/OQ/PQs
- Proficient in life science manufacturing processes (biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy)
- Baseline Guide 5 (Second Edition) familiarity is a plus
- Isolators qualification protocols execution and reporting, VHP cycle development, GMP knowledge (preferred)
- Excellent MS Word and Excel skills
- Strong English (oral and written)
- Willingness to travel within Italy and abroad
- strong problem-solving skills
- excellent written and verbal communication
- ability to work independently and build a project team
- CQV documentation and protocol writing
- field verification and system walkdowns
- FAT/SAT/IOQ/PQ execution
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