Automation Lead - Pharmaceutical
WeHunt ·
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.