CQV ENGINEER ITALY

Overview

CAI is a professional services company established in 1996 that serves Life Sciences and Mission Critical industries. We provide accelerated operational readiness and high-performance solutions through our rigorous approach, field-tested processes, and extensive expertise. Our Foundational Principles guide professional and personal conduct: integrity, serving each other, serving society, and investing in our future.

Responsibilities

• Develop documentation to support Commissioning, Qualifications, and Validation (CQV) at pharmaceutical facilities, utilities, and equipment
• Write and execute protocols, perform field verification, and develop summary reports at client sites
• Support onsite and offsite CQV activities such as FATs, SATs, IOQ, PQ executions, and system walkdowns
• Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion
• Provide cGMP leadership and guidance for the delivery of CQV services to Life Sciences clients
• Collaborate with project teams, build and nurture a project team, and work independently while meeting deadlines
• Proficiently apply knowledge of life science manufacturing processes (biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent) and related equipment
• Travel as required within Italy and possibly other parts of Europe

Position Requirements

• BS or MS in a relevant science or engineering field, or equivalent hands-on experience
• Minimum 4–8 years of commissioning and/or qualification experience in an FDA-regulated industry
• Experience with facilities and equipment startup, walkdowns & troubleshooting, utilities (WFI, RO, HVAC), building automation, FAT/SAT, URS, design reviews, P&IDs, IQ/OQ/PQ
• Ability to lead and provide guidance for CQV services; strong technical problem-solving and troubleshooting skills
• High attention to detail; ability to multi-task and meet deadlines; strong written and verbal English
• Ability to work independently and build a project team quickly
• Familiarity with Baseline Guide 5 (Second Edition) is a plus
• Expertise in Microsoft Word and Excel
• Willingness to travel (Italy and possibly Europe)
• Interest in a safe, inclusive work culture and adherence to diverse hiring practices

EEO compliance: La selezione rispetta il principio delle pari opportunità (l. 903/77)