Validation Engineer

In breve

CAI is a global professional services firm that supports Life Sciences and mission‑critical sectors with accelerated operational readiness and high‑performance solutions. Established in 1996, the company now employs nearly 800 people worldwide and operates under a purpose‑driven approach that emphasizes integrity, service, and future‑focused innovation. The opening role is for a Validation Engineer, specifically a CQV (Commissioning, Qualification, Validation) Engineer, based in Italy, tasked with creating and managing the documentation that underpins the commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment for CAI's clients. On a day‑to‑day basis the CQV Engineer will author and execute protocols, conduct field verification, and compile summary reports at client sites. Responsibilities include managing the full C&Q documentation lifecycle from SLIA generation through OQ completion, supporting both onsite and offsite activities such as FATs, SATs, IOQ and PQ executions, and performing system walk‑downs. The role also requires providing cGMP leadership, troubleshooting technical issues, and coordinating multidisciplinary project teams while ensuring strict adherence to deadlines. The position demands a European citizen or a valid residence permit for Europe, and prior experience within a GMP‑regulated pharmaceutical environment. Candidates must hold a BS or MS in a relevant science or engineering discipline, or possess equivalent hands‑on experience, and have between four and eight years of commissioning or qualification work in an FDA‑regulated setting. High attention to detail, strong multitasking abilities, and the initiative to complete tasks accurately are essential. Fluency in oral and written English, proficiency with Microsoft Word and Excel, and the willingness to travel 100 % within Italy and abroad are also required. Technical problem‑solving skills and the capacity to work independently while quickly building project teams are expected. Preferred qualifications include familiarity with Baseline Guide 5 (Second Edition), experience with isolator qualification protocols, VHP cycle development, and broader GMP knowledge. Additional expertise in biotech, aseptic processing, fill/finish, OSD, gene‑therapy manufacturing, as well as hands‑on work with utilities such as WFI, RO, HVAC, building automation, FAT/SAT, URS, design reviews, P&IDs, and IQ/OQ/PQ generation, would be advantageous. The role offers a gross annual salary between €45,000 and €57,000, calibrated to the candidate's technical competencies and relevant experience, and aligns with CAI's commitment to equal opportunity hiring. What the role asks for: - European citizenship or valid EU residence permit - Experience in GMP‑regulated pharmaceutical industry - BS or MS in relevant science/engineering or equivalent experience - 4–8 years commissioning/qualification in FDA‑regulated environment - High attention to detail - Excellent oral and written English - Proficiency in Microsoft Word and Excel - Availability for 100 % travel in Italy and abroad - Familiarity with Baseline Guide 5 (Second Edition) (nice‑to‑have) - Experience with isolator qualification and VHP cycle development (nice‑to‑have)