Automation Lead - Pharmaceutical
WeHunt · Monza, Lombardia ·
Purpose The Automation Lead reporting to the Engineering - Coordinate external suppliers and consultants for installation activities of new automation systems at Customer manufacturing affiliates; - Participate in design, installation and testing activities of control systems, production lines, process machines and industrial plants in general; - Provide guidance as an automation expert to other business functions, in particular to Process Engineering, Quality and Validation in matters of CSV (Computer System Validation); - Provide support and interact with local automation units at Customer manufacturing affiliates; - Manage Global Automation SOP and guidelines and their deployment and/or revision; - Collaborate with the Global ICT department to implement automation systems in manufacturing areas to ensure compliance to the highest OT Cybersecurity Standards; - Carry out a continuous scouting of new technologies and applications, fostering the digitalization of the Group's manufacturing processes.
Experience Required - 4-5 years of experience in a similar role in the pharmaceutical sector; - Previous solid experience as a Software Developer / Automation Engineer in the pharmaceutical sector. Education Bachelor or Master's Degree in Automation Engineering or equivalent.
Languages Fluent English (both written and spoken) Technical Skills - Experience 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); - Knowledge of GAMP and GMP, with particular reference to EU GMP Annex 11 related to management and validation of computerized systems in pharmaceutical sector; - Knowledge of 21 CFR Part 11 and Data Integrity principles in pharmaceutical sector; - Knowledge of the Vertical Integration Standard ISA-S88/95 for automation systems in Manufacturing; - Knowledge of OT Cybersecurity principles and related International Standards (e.g., NIST 800-82 and IEC-62443); - Knowledge of Industry 4.0 principles, Artificial Intelligence, Predictive Maintenance and Machine Learning; - Knowledge of virtualization systems (e.g., VMware), Windows and Unix-based operating systems, computer networks, and major Field Buses; - Knowledge of Database relationships (e.g., SQL Server) and Historian systems (e.g., OSI-PI); - Knowledge of manufacturing execution systems (MES), ERP, CMMS, Track - Knowledge of quality management systems (e.g.
TrackWise) and Change Control flows in pharmaceutical sector. Soft Skills - Analytical and strategic thinking aimed at solving complex technical problems; - Quality orientation and results-oriented approach; - Technical Leadership aptitude with communication and negotiation skills to influence and drive change; - Ability to interact with different teams and functions during the resolution of technical issues; - Ability to coordinate external resources, vendors and consultants during planning, management and execution of automation projects.