06 ott - Bardi
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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