Automation Lead - Pharmaceutical

Wehunt; Monza; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Wehunt is seeking an Automation Lead to drive the technological evolution of automation systems across Group affiliates in the Global Manufacturing Division. The role focuses on OT standards, strategic Capex projects, and collaboration with Global ICT to ensure robust cybersecurity and digitalization of manufacturing processes.

You will support local automation units, manage SOPs, and participate in CSV and GMP/GAMP-related activities within the pharmaceutical environment, requiring 4–5 years of

Competenze

• 4-5 years of experience in a similar role in the pharmaceutical sector.
• Solid experience as a Software Developer / Automation Engineer in the pharmaceutical sector.
• Bachelor or Master Degree in Automation Engineering or equivalent.

Mansioni

• Monitor and promote global digitalization initiatives in automation area following Project Management principles.
• 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.

Conoscenze

PLC programming

HMI/SCADA

DCS

ISA-S88/95

OT cybersecurity

Industry 4.0

SQL/OSI-PI

MES/ERP/CMMS

GAMP/GMP

Data Integrity (21 CFR Part 11)

Virtualization/Windows/Unix

Formazione

Bachelor or Master in Automation Engineering

Descrizione del lavoro

Purpose

The 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.

Main Responsibilities

• Monitor and promote global digitalization initiatives in automation area following Project Management principles;
• 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 & Trace;
• Knowledge of quality management systems (e.g. TrackWise) and Change Control flows in pharmaceutical sector. xysqume

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.

Location

Automation Lead - Pharmaceutical • Monza, Italy