Valerio Malenchini

Background

About Valerio Malenchini

Process Analytical Technology (PAT) Lead for EMEA region. First line Manager with a decade of IT engineering and management experience within highly regulated industries (Pharmaceutical, Manufacturing, Investment Banking, IT and Telecommunication). Currently leading the EMEA PAT and MES organization for MSD, one of the largest Pharmaceutical Company in the globe. Project Management skills to drive from Collecting Business Functional Requirements/Planning to Delivery and Support projects up to 9 mil USD so far (i.e. Continuous Manufacturing Integration project in 2018 on our UK based site). Microsoft and ITIL certifications. Several minor technical certifications (including SQL, Linux and Networking knowledge) and continuously training on both IT and soft skills. Ability to act as a focal point between stakeholders, business, infrastructure teams and third party vendors to deliver the highest quality projects, defining the best and cost saving strategies, managing vendor licenses and contracts (including overseen of Purchasing Orders). Act as escalation point for Application Management Team to troubleshoot and resolve complex issues, assisting with Post Mortem investigations, Problem Management, CAPAs (Corrective and Preventive Actions) and IT Variances. Completed several Siemens SIPAT Installation/Upgrade/Integration for continuous manufacturing projects across Europe (UK, Netherlands, Ireland) and North America. Siemens SIPAT expert on versions 4.1 and 5.0. Trained in Bruxelles at SIEMENS premises by Developers and SIPAT expert support team. Installation / Integration of new Analyzers / Instruments (Bruker, Thermo Antaris, Waters UPLC, Horiba Aqualog, etc) Capable of installing a new architecture of SIEMENS SIPAT software by building required MS SQL database instances, configuring Central Databases, Base Stations and Collector Stations, together with its OS, Network, Firewalls, OPC and DCOM settings. Experience in installing and configuring calculation models such as Unscrambler Prediction Engines from CAMO and SIMCAQ from Umetrics. MVDA expertise (Multivariate Data Analysis). Umetrics SIMCA-online expert, including the ability to upgrade system architecture and add additional SimAPI (PI from OSIsoft, PI AF, BatchTableWrapper, ODBC, SIPAT, etc) Change control and full SDLC (Service Development Life Cycle) package expert. Knowledge of GxP, GmP and ALCOA standards to ensure Data Integrity and to comply with Quality Unit and External Audits (i.e. FDA, EMA, etc)