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Senior Automation Specialist

2 months ago

Marquand, Missouri, United States Novartis Group Companies Full time

Job Summary

The Senior Automation Specialist supports automation systems, interfaces, and equipment. Responsible for the management of automation systems across the facility, ensuring compliance with internal GMPs, CSV, and external regulatory requirements.

Key Responsibilities

  • Manage the overall automation asset care strategy for the site, including upgrades, maintenance contracts, and changes.
  • Responsible for the management, support, and execution of automation qualification, as well as the resolution of all 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.