Staff II CQV Engineer

CAI

CQV Engineer developing documentation to support commissioning and validation at pharmaceutical facilities in Italy. Responsible for protocol writing, execution, and quality assurance activities.

Posted 5/25/2026full-time🇮🇹 ItalyLeadWebsite

About the role

Key responsibilities & impact

Develops documentation to support Commissioning, Qualifications, and Validation
Responsible for protocol writing and execution, field verification, and development of summary reports at client sites
Provide cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients
Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns

Requirements

What you’ll need

BS or MS in a relevant science or engineering field, or equivalent hands-on experience
Minimum 4 – 8 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry
Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution
Excellent technical problem-solving and troubleshooting skills
Familiarity with Baseline Guide 5 (Second Edition) a plus
Expertise in Microsoft Word and Excel
Excellent oral and written English

Benefits

Comp & perks

Health insurance
Professional development
Paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

protocol writingfield verificationcGMPcommissioningqualificationFATSATIOQPQtroubleshooting

Soft Skills

technical problem-solvingleadershipcommunication