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Senior Automation Engineer

2 months ago

Indianapolis, Indiana, United States Novartis Full time
Job Description Summary

The Senior Automation Engineer plays a critical role in supporting automation systems, interfaces, and equipment. This position is responsible for managing automation systems across the facility, ensuring compliance with internal GMPs, CSV, and external regulatory requirements.

Key Responsibilities
  • Manage automation systems, including building management systems (BMS), room monitoring systems (EMS), process and laboratory equipment automation.
  • Develop and implement an automation asset care strategy for the site, including upgrades, maintenance contracts, and changes.
  • Resolve automation-related issues and manage automation qualification.
  • Update and develop user requirement specifications, functional specifications, design specifications, operation, and maintenance for new and existing control systems.
  • Collaborate 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 and maintain a stable and productive automation environment through oversight, preventative maintenance, and standard operating procedures.
  • Manage 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.