Senior CQV Engineer — GMP Validation for Life Sciences

CAI; Lombardia; On-site; EUR 45,000 - 57,000; Full time

Job summary

CAI is seeking a CQV Engineer to join its growing operations in Italy. The role develops documentation to support Commissioning, Qualifications, and Validation, including protocol writing and field verification at client sites.

The candidate will provide cGMP leadership, manage CQV activities across facilities and equipment, and support FAT/SAT, IQ/OQ/PQ processes with strong English communication and teamwork.

Qualifications

• BS or MS in a relevant science or engineering field or equivalent hands-on experience.
• 4–8 years’ experience in commissioning/qualification in an FDA-regulated industry.
• Experience with facilities and equipment startup, walk downs, utilities, FAT/SAT, IQ/OQ/PQ.
• Knowledge of cGMP leadership and CQV service delivery for Life Sciences clients.
• Excellent problem-solving and English communication skills.

Responsibilities

• Develop CQV documentation to support Commissioning, Qualification, and Validation.
• Write and execute protocols, perform field verifications, and prepare summary reports at client sites.
• Support onsite and offsite activities including FATs, SATs, IOQ, PQ executions, and system walkdowns.

Skills

Attention to detail

English proficiency

Project management

Team leadership

Independent work

Education

BS or MS in science/engineering

Tools

Microsoft Word

Microsoft Excel

Job description

CAI is seeking a CQV Engineer to join its growing operations in Italy. The role develops documentation to support Commissioning, Qualifications, and Validation, including protocol writing and field verification at client sites.

The candidate will provide cGMP leadership, manage CQV activities across facilities and equipment, and support FAT/SAT, IQ/OQ/PQ processes with strong English communication and teamwork.