Domenico Ciaraldo
Csv & Data Integrity Specialist @Thermo Fisher Scientific
Signup · Get unlimited contacts
WORK HISTORY
Csv & Data Integrity Specialist @Thermo Fisher Scientific
Ferentino, IT
Coordinated validation projects across lab and production systems, ensuring compliance with Annex 11, FDA 21 CFR Part 11, and corporate SOPs.• Oversaw implementation and qualification of OT and automation systems including Rockwell FactoryTalk, iFIX, WinCC, and SAMI Korber, ensuring alignment with production and logistics process requirements.• Performed validation and lifecycle activities according to GAMP5 Guidelines on critical equipment and automation platforms (HVAC, autoclaves, glove testers, isolators, filling lines), integrating SCADA/HMI systems with quality and operations workflows.• Managed backup and restore processes for computerized systems, contributing to data integrity and disaster recovery readiness.• Authored and reviewed validation documents (URS, RA, IQ/OQ/PQ protocols, reports), conducted periodic reviews, and handled deviation/CAPA management via Trackwise.• Supported the Quality Operations department in investigating and resolving anomalies and deviations involving computerized systems, ensuring timely corrective actions and documentation.• Collaborated as part of Data Integrity teams to perform system DI risk assessments DI Audits and support corporate compliance strategies.• Involved as Subject Matter Expert (SME) providing technical support and documentation during regulatory inspections (AIFA, FDA, MFDS, etc.).
EDUCATION
Università degli Studi di Napoli Federico II
Laurea Magistrale LM, Ingegneria chimica
Università degli Studi di Napoli Federico II
Laurea triennale, Ingegneria chimica
ABOUT DOMENICO CIARALDO
Open-minded and driven automation and validation specialist, with a strong background in the pharmaceutical industry and a passion for technology. I began my career as a maintenance engineer and evolved into a specialist role focused on the compliance, reliability, and lifecycle management of critical computerized and OT systems in highly regulated environments. With over three years of experience, I have successfully developed and executed validation strategies across lab and production environment, coordinating cross-functional teams and external suppliers to deliver projects on time, on budget, and in alignment with data integrity standards. My technical expertise spans automation software (iFIX, WinCC, FactoryTalk, SAMI Korber), validation tools (HPALM, Trackwise), and industrial processes, supported by a proactive mindset and commitment to continuous learning
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.