09 set - Monza
WeHunt
ph3bPurpose /b /h3 pThe Automation Lead reporting to the Engineering Maintenance Site Manager, is responsible for leading the technological evolution of automation systems for the Group affiliates within the Global Manufacturing Division (GMD) perimeter. In the Operational Technology (OT) area, he/she will be responsible for spreading certain Architectural and Design Standards for automation systems, collaborating as a reference figure on Capex projects managed by Global Engineering. At the same time, he/she will manage initiatives aimed at implementing OT Cyber Security, Industry 4.0 principles and digitalization in Manufacturing, performing a continuous scouting of new technologies and applications, with a strong collaboration with Global ICT. He/she will also provide support to the local Automation organizations of Customer manufacturing sites in defining Standard Operating Procedures (SOPs) aimed at managing the lifecycle of computerized systems in the Pharma environment, in accordance with EU GMPs and GAMPs. /p h3bMain Responsibilities /b /h3 ul liMonitor and promote global digitalization initiatives in automation area following Project Management principles; /li liCoordinate external suppliers and consultants for installation activities of new automation systems at Customer manufacturing affiliates; /li liParticipate in design, installation and testing activities of control systems, production lines, process machines and industrial plants in general; /li liProvide guidance as an automation expert to other business functions, in particular to Process Engineering,
Quality and Validation in matters of CSV (Computer System Validation); /li liProvide support and interact with local automation units at Customer manufacturing affiliates; /li liManage Global Automation SOP and guidelines and their deployment and/or revision; /li liCollaborate with the Global ICT department to implement automation systems in manufacturing areas to ensure compliance to the highest OT Cybersecurity Standards; /li liCarry out a continuous scouting of new technologies and applications, fostering the digitalization of the Group's manufacturing processes. /li /ul h3bExperience Required /b /h3 ul li4-5 years of experience in a similar role in the pharmaceutical sector; /li liPrevious solid experience as a Software Developer / Automation Engineer in the pharmaceutical sector. /li /ul h3bEducation /b /h3 pBachelor or Master's Degree in Automation Engineering or equivalent. /p h3bLanguages /b /h3 pFluent English (both written and spoken) /p h3bTechnical Skills /b /h3 ul liExperience in software development and/or as System Integrator with particular reference to programming of process control and supervision systems in industrial environment (e.g. PLC, HMI, SCADA and DCS); /li liKnowledge of GAMP and GMP,
with particular reference to EU GMP Annex 11 related to management and validation of computerized systems in pharmaceutical sector; /li liKnowledge of 21 CFR Part 11 and Data Integrity principles in pharmaceutical sector; /li liKnowledge of the Vertical Integration Standard ISA-S88/95 for automation systems in Manufacturing; /li liKnowledge of OT Cybersecurity principles and related International Standards (e.g., NIST 800-82 and IEC-62443); /li liKnowledge of Industry 4.0 principles, Artificial Intelligence, Predictive Maintenance and Machine Learning; /li liKnowledge of virtualization systems (e.g., VMware), Windows and Unix-based operating systems, computer networks, and major Field Buses; /li liKnowledge of Database relationships (e.g., SQL Server) and Historian systems (e.g., OSI-PI); /li liKnowledge of manufacturing execution systems (MES), ERP, CMMS, Track Trace; /li liKnowledge of quality management systems (e.g. TrackWise) and Change Control flows in pharmaceutical sector. xysqume /li /ul h3bSoft Skills /b /h3 ul liAnalytical and strategic thinking aimed at solving complex technical problems; /li liQuality orientation and results-oriented approach; /li liTechnical Leadership aptitude with communication and negotiation skills to influence and drive change; /li liAbility to interact with different teams and functions during the resolution of technical issues; /li liAbility to coordinate external resources, vendors and consultants during planning, management and execution of automation projects. /li /ul h3bLocation /b /h3 pAutomation Lead - Pharmaceutical • Monza, Italy /p /p #J-18808-Ljbffr
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