Senior Automation Engineer

5 days ago


Indianapolis, Indiana, United States Novartis Full time
Job Description

Job Summary:

The Senior Automation Engineer will be responsible for managing and maintaining automation systems across the facility, ensuring compliance with internal GMPs, CSV, and external regulatory requirements.

Key Responsibilities:

  • Manage automation systems, including building management systems, room monitoring systems, process and laboratory equipment automation.
  • Develop and implement automation asset care strategies, including upgrades, maintenance contracts, and changes.
  • Manage automation qualification and resolve automation-related issues.
  • Update and develop user requirement specifications, functional specifications, design specifications, operation and maintenance for new and existing control systems.
  • Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
  • Work closely with multiple disciplines, including manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification to manage a diverse portfolio of projects.
  • Manage resources to plan, develop, and execute automation projects from start-up to completion.
  • Establish, monitor, and maintain a stable and productive automation environment through oversight, preventative maintenance, and standard operating procedures.
  • Manage and oversee project work plans, meetings, decisions, project deliverables, progress reports, schedules, cost tracking, and other pertinent reports.
  • Provide and/or coordinate vendor training to new users of automation systems.
  • Ensure cGMP and CSV compliance with all internal Novartis and external regulatory requirements.
  • Work collaboratively to address data integrity issues.
  • Initiate and execute change control activities for automation systems.
  • System/Application owner for automation systems interfacing with IT on server, network, and infrastructure.
  • Manage resources (external) for providing technical support to operations and support personnel.
  • Own and close corrective actions related to automation systems.

Requirements:

  • Bachelor's degree in engineering, computer science, automation, or related field with 7+ years of relevant engineering experience in the Chemical or Pharmaceutical industry or 10+ years of relevant engineering experience in lieu of a degree.
  • Good oral and written communication skills.
  • Knowledge of FDA regulations, particularly 21 CFR part 11 and GMP systems.
  • Shows the appropriate sense of urgency around given tasks.
  • Pharmaceutical based GMP manufacturing operations including aseptic fill/finish and/or radio pharmacy is preferred.
  • Training in radiochemistry or radio pharmacy is preferred.
  • Radiation safety education is preferred.


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