Automation Validation Engineer

AbbVie•North Chicago, IL
•$78,500 - $141,000

About The Position

The Automation Validation Engineer provides leadership and direction for software validation activities, including reviewing software requirements, developing and reviewing validation plans, strategies, test cases and instructions, executing and reviewing validation tests, and maintaining departmental procedures and templates. The role provides validation support for operational technology (OT) projects, primarily involving DeltaV and/or Allen-Bradley PLCs, as well as ongoing manufacturing automation validation activities. The engineer works with project engineers and project managers throughout the System Development Life Cycle, supporting Factory Acceptance Testing and ensuring software quality assurance while meeting project objectives and deliverables. The position manages validation activities including protocol writing, risk-control identification, document review and storage, and problem-report resolution. It also performs minor troubleshooting during commissioning and documents unresolved issues. The role implements Validation Quality Assurance standards in departmental documents, ensures departmental training is complete, and owns OT System Periodic Validation Review, Data Integrity and Data Security lifecycles, including remediation task closures. Acting as a liaison between OT/Automation and Validation Quality Assurance, the engineer also supports audits and interacts with auditors. Project tasks must be completed within time and budget constraints. The engineer may supervise contract validation resources.

Requirements

  • Bachelor’s degree in engineering preferred plus 5 years of experience, or a Master’s degree plus 4 years of experience preferred, or sufficient experience to demonstrate technical equivalency.
  • Experience in one or more of the following: IS support, systems testing, OT implementation, quality assurance, supervision, or project management.

Nice To Haves

  • Bachelor’s degree in engineering with 5 years of experience.
  • Master’s degree with 4 years of experience.

Responsibilities

  • Lead and direct software validation activities, including reviewing requirements, preparing and reviewing validation documentation, executing and reviewing test cases, and updating procedures and templates.
  • Provide validation support for OT projects, primarily involving DeltaV and/or Allen-Bradley PLCs, and ongoing manufacturing automation validation activities.
  • Support Factory Acceptance Testing with Project Engineers to confirm unit acceptability.
  • Ensure software quality assurance during OT projects while meeting project objectives and deliverables.
  • Work with Project Managers across all phases of the System Development Life Cycle.
  • Manage validation activities, including protocol writing, identification of risk controls, review and storage of controlled documents, and resolution of problem reports.
  • Perform minor troubleshooting during commissioning and document unresolved issues.
  • Implement Validation Quality Assurance standards in departmental documents and ensure departmental training is complete.
  • Own OT System Periodic Validation Review, Data Integrity and Data Security lifecycles, including managing and executing remediation task closures.
  • Liaise between the OT/Automation department and Validation Quality Assurance and support audits, including interacting with auditors.
  • Complete project tasks within time and budget constraints.
  • May supervise contract validation resources in the timely completion of activities in the area of responsibility.

Benefits

  • Paid time off, including vacation, holidays and sick leave.
  • Medical, dental and vision insurance for eligible employees.
  • 401(k) for eligible employees.
  • Eligibility to participate in short-term incentive programs.
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