CQV Engineer II
Job in
Milan, Lombardy, Italy
Listed on 2026-06-17
Listing for:
Experteer Italy
Full Time
position Listed on 2026-06-17
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Biomedical Engineer, Regulatory Compliance Specialist
Job Description & How to Apply Below
Experteer 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.
Retribuzione / Benefits 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
ResponsabilitàBS or MS in a relevant science or engineering field, or equivalent experience4–8 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/PQsProficient 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
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