Sr. Specialist DDIT Ops ITOT Automation Eng

Summary

The Automation Engineer Specialist – RLT Manufacturing Lines will support the OT scope of RLT manufacturing lines being deployed and operated across the RLT Network and support the development of new lines. The Automation Engineer Specialist is responsible for managing the automation scope, process flows, and computer system validation for an automated manufacturing line used in radioligand therapies. The successful candidate will ensure the smooth operation of the OT scope of the automated lines across the network and coordinate with cross-functional teams both locally and globally. Strong communication skills are required, as the RLT Line Automation Engineer will interact with the automated line vendor and ensure that timelines and service level agreements (SLAs) are met.

About The Role

Key Responsibilities

• Provide technical expertise for the design, configuration, installation, and maintenance of automation software and associated hardware, including interacting with other teams as necessary.
• Understand typical manufacturing process flows and the application of automation systems.
• Develop and maintain the OT and computer system validation processes to ensure compliance with regulatory requirements and industry best practices.
• Lead project teams to successful outcomes, preparing project scopes of work and completing required work within project timelines.
• Translate business requirements into technical solutions and act as a global technical expert for the system, supporting complex technical issues in collaboration with vendors.
• Develop and implement strategies to optimize the performance, reliability, and efficiency of the OT systems used on the automated manufacturing lines.
• Collaborate with stakeholders to identify and address any issues or challenges related to the automation and computer system validation processes.
• Stay up to date with industry trends, advancements, and regulations related to automation in radioligand therapy manufacturing.
  
  

Essential Requirements

• Bachelor’s degree in Engineering, Computer Science, or a related field.
• Minimum of 7 years of experience in IT or Automation, in a GMP Pharma environment.
• Strong knowledge and understanding of automation systems, computer system validation, and regulatory requirements in the pharmaceutical industry.
• Proficient in project management methodologies and tools.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Strong leadership and decision-making abilities.
• Detail-oriented, with excellent problem-solving and analytical skills.
• Ability to thrive in a fast-paced, dynamic environment.
  
  

Desirable Requirements

• Experience with Aseptic Manufacturing.
• Knowledge of radioligand therapy manufacturing processes and equipment is a plus.
• Fluency in Italian is a plus.
  
  

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

This role is based can be based in Ivrea, Ljubljana or Zaragoza. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you

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