The Manager of Automation Engineering is responsible for leading and overseeing the implementation of automation technologies and strategies in the Villa Guardia manufacturing site within a GxP environment, to improve efficiency and to keep the manufacturing at the best industry standards in cooperation with the Global Engineering and with the Automation Engineering of the Internal Manufacturing sites. He/She is responsible for the Building & Process Automation improvement activities, to drive the new Process Control and Safety Systems deployments across Villa Guardia Site and to provide maintenance support for the existing Manufacturing Process Control Systems.

Essential Functions/Responsibilities

• Design and implement Hardware and Software solutions in accordance with Standard Operating Procedures and the Global Automation Policy.

• Cooperate with the Global Engineering, Internal Manufacturing sites Automation Engineers and IS for the TechOps Automation Roadmap implementation, including the definition of the automation systems interfaces with the IT infrastructure.

• Support the Site Engineering in the activities of specification and follow up of pharmaceutical plants and equipment using established procedures. These include equipment selection, schematic design, system layout, cost estimation and system documentation.

• Develop and implement control and automation design based upon cause-and-effect documentation, P&IDs, control narrative and an understanding of the environment.

• Ensure accuracy and reliability of instrumentation, control and safety systems.

• Actively identify & pursue process quality, efficiency, and safety improvements, by maintaining cGxP and H&S knowledge applicable to the job and by assessing them against of the “State of the Art” technology.

• Write and update SOPs and other Process Control System associated documentation as part of the operational lifecycle.

• Cooperate with the Site Engineering, QA and IS Compliance departments to ensure production continuity and fast problem resolutions and tasks such as audits, CAPAs and validation testing are completed on time successfully and as priority. In particular:

  • Ensure that deployed systems are available for Manufacturing, maintained, and their qualified status is not compromised.

  • Cooperate with the Manufacturing team, ensuring all system changes are communicated ahead of time and that production schedule is accounted for.

  • React quickly to reports of Manufacturing system faults, troubleshoot in collaboration with Manufacturing and the other Engineering disciplines.

  • Assist in the development software and hardware configuration to remediate system faults or errors, improve efficiency and safety, as requested and in response to CAPA or Error report actions.

  • Carry out preventative and planned maintenance activities on time and suggests/identifies maintenance requirements where needed.

  • Carry out system modifications in accordance with the appropriate Change Control procedure.

For his/her Area of competence, he/she carries out the operating procedures for the management of his/her activity in compliance with the Principles of the Environmental Policy and the Quality System, applies the relevant guidelines and indications contained in the procedures of the Environmental Management System of his/her competence.

Participates in the training and education courses in the field of the Environmental, Safety and Quality Management System and in the training courses on Procedures, Instructions, Manuals and Operating Protocols.

He/She is responsible for carrying out his/her activities so that the management of environmental and safety aspects is conducted correctly. Carries out the work activities, in compliance with the directives received, as required by Legislative Decree 81/08 Guarantees compliance with all applicable Laws, Codes, company standards and Procedures relating to his/her area of competence, particularly the requirements of the Jazz Pharmaceuticals Code of Conduct.

Required Knowledge, Skills, and Abilities

• Advanced knowledge of Distributed Control and Safety Systems and/or PLC applications.

• Awareness of integrated process control SIMATIC Batch (batch processing).

• Good demonstratable knowledge of Batch process.

• Working knowledge of GAMP and GEP.

• Database administration experience (SQL).

• Advanced PLC programming skills (eg STL, SCL).

• High level programming eg: C, C++, VB etc.

• Completed structured system testing and documentation such as FAT/SAT/OQ protocols.

• Followed system maintenance programmes.

• Completed system version upgrades.

• Capability to install, configure and update Process Control System software (Siemens brand is preferred). Experience of Siemens products (e.g. PCS7).

• Experience in maintaining and upgrading PLC or DCS control systems.

• Experience in designing, maintaining and upgrading network infrastructures

• Soft skills:

  • Able to form long term relationships with key support groups, QA, engineering, CSV group and senior managers across the site.

  • Shares ideas and information and acts in a transparent manner

  • Demonstrates a ‘can do’ approach.

  • Willing to learn new technologies and their application relevant to the job

  • Fluent English

  • Good oral, written and presentation skills essential

• Following capabilities will be considered a valuable plus:

  • Experience on the installation, configuration and updating of Process Control System software from major vendors other than Siemens (ABB, Emerson, Rockwell etc.)

  • Experience in the Pharmaceutical Industry

  • Experience of Safety Instrumented Systems

  • Experience of commissioning activities

  • Operational Excellence / Lean manufacturing skills and/or certifications (i.e: Green or Black Belt)

Required/Preferred Education and Licenses

• Master’s degree in engineering, Electrical, Automation or any relevant technical education

• 7 ÷ 10 years’ experience of PLC based unit operation including graphical interface and data collection