Engineering & Automation Strategy Manager

We are looking for an Engineering & Automation Strategy Manager for our Campoverde site, with following responsibilities:

Job core responsibilities GMP:

1. Project Lead, design and development interface from IT Systems (OSI-PI/MES/Maximo) versus OT system
2. Design, implement and maintain an infrastructure Network (MCN), Hardware and Software for automation systems that allows the integration of information flows between field process control systems.
3. Support and facilitate future integration of PCS (process control system) with OT Core Systems.
4. Being the point of reference for the Automation projects in the plant and the connection with the international structures to signal the local experience and contribute to the development of international projects on the Site.
5. Ensuring the development, operation and maintenance of information and Automation systems for the application areas of competence, formulating solutions that optimize the cost/performance ratio in compliance with company standards and applicable regulations.
6. Coordinate and support multi-functional teams in the study, design, implementation, and functional verification of automation systems in compliance with corporate and industrial standards and applicable regulations
7. To periodically check the progress of projects in terms of costs, risks, scheduling and results by communicating and interacting with the specific and appropriate company functions

Job core responsibilities EHS:

Ensure responsibility and commitment in achieving the goals of continuous improvement of EHS performance and Energy and in maintaining legal compliance through active participation in AbbVie's EHS programs. He is a “Lavoratore” (Art. 18. Obblighi del preposto D.Lgs. 81/08) “Tutela della Salute e della Sicurezza dei Lavoratori nei Luoghi di Lavoro”.

Description of responsibilities GMP:

1. In details:

• Act as the Project Lead for the Connection between IT (OSI-PI/MES/Maximo) and OT Core System implementation at the site for both Pharma Packaging & Drug Manufacturing API and Pharma.
• Coordinate the efforts of the various teams involved: Operations, BTS, Quality, DPO, Engineering
• Report to both local and global stakeholder teams project status, risks and remediation plans
• Be final accountable of project financial and timeline for the Automation implementation.
• Design the integration layer between manufacturing execution and automation control systems.

2.In details:

• Coordinate implement and maintain an infrastructure Network (MCN), Hardware and Software for automation systems that allows the integration of information flows between field process control systems.
• Implement and maintain new architecture interfacing with infrastructure team and other departments.
• Assure the new implementation in compliance with regulatory requirements (Annex 11, CFR21 part 11).
• Lead Data integrity project (Supplier Evaluation of OT System, New System, Audit Trail)
• Guarantee innovative approach in design and operation for all automation systems at the Site.

3.In details:

• Lead and design the interface between field Process Control Systems and OSI-PI or other shop floor systems.
• Identify opportunities for automation within current software processes and systems.
• Guarantee the introduction of new technologies and standards in the PCS areas.
• Ensuring maximum standard of automation.
• Respect compliance and industrial standards.

4.In details:

• Creation of a local and global team to lead all the site system projects.
• Share the experience with the global team and Automation CoE
• Facilitate the development of global project in the Site.
• Share experiences with the teamwork in the Automation space.
• Identify adequate and necessary formation plan.
• Execute training sessions or organize attendance.
• Follow current training procedure to document and guarantee qualification.

5. In details:

• Ensuring maximum standard of automation.
• Respect compliance and industrial standards.

6. In details:

• Support multi-functional teams to create automations system in compliance with industrial standards and applicable regulations.
• Coordinate the qualified personnel.

7.In details:

• Collaborate with other business units to understand how automation can improve workflow.
• Gather requirements from functions or end-users to develop the best Automation solutions.
• Review periodically the progress project in terms of cost, risk, times and results

Description of responsibilities EHS:

1. Maintain safe and healthy working conditions for all employees under their supervision. Attend the EHS training and education courses provided and make sure employees under their own supervision participate in the mandatory EHS training courses.

In details:

• Follow all EHS rules and procedures in force in your department.
• Participate in all mandatory EHS training courses.
• Wear the necessary PPE.
• Communicate to Supervisors any proposal that offers opportunities for improvement of the EHS program.
• Actively participate in pollution prevention and waste reduction programs.
• Working in compliance with safety and environmental protection standards means adhering to the spirit of the EHS Policy
• protect one's own health and that of other people in the workplace.
• Undergo checks and visits as per the Health Surveillance protocol.

Requirements

• Master’s degree in Management and Automation Engineering or related
• Documented knowledge and experience in the following areas:
  • AR/VR model development and implementation
  • Edge computing and IoT technologies
  • Local private blockchain technology and smart contract integration
  • Next-generation robotics, including collaborative robots and autonomous mobile robots (AMRs) into manufacturing workflows.
  • Digital thread and digital twin
  • Sustainable manufacturing practices and technologies
  • Quantum computing principles and applications in manufacturing scenarios
  • Experience with low-code/no-code platforms and their application in manufacturing
  • Cyber-physical systems (CPS) and advanced HMI for Distributed Manufacturing Execution System
  • AI, machine learning, and data analytics
• Analysis, design and implementation of SCADA systems in the pharmaceutical field realized with visual basic technology and Database ServerSQL server. Consulting on complex IT architectures
• Project management activities: cost control, resource management, relationship with suppliers, drafting of GMP documentation.
• Management and coordination of distributed control systems (DCS) and PLC-SCADA related to production equipment such as fermenters, bioreactors, utilities and automatic machines.
• Experience in Documentation writing of RAS, URS, SFS, NDS, HDS. Writing and execution of FAT / SAT and IQ / OQ qualification protocols
• Deviation Management and CAPA with Quality Assurance and Production for the resolution of known problems
• Application and usage of quality validation directives and methods such as CFR21 part 11, GAMP and S88 standards