Automation Engineer

$92,800 - $139,200/Yr

Novartis - Indianapolis, IN

posted 3 months ago

Full-time - Mid Level
Indianapolis, IN
Chemical Manufacturing

About the position

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Supply Chain professionals to help us reach our ambitious goals. The role involves engineering support for automation systems, interfaces, and equipment, with a primary focus on oversight of the automation systems across the facility, including building automation systems (BAS), room monitoring systems (RMS), and process and laboratory equipment automation. This position is crucial in ensuring the site's compliance with internal Good Manufacturing Practices (GMP), Computer System Validation (CSV), and external regulatory requirements. The successful candidate will be responsible for the overall automation asset care strategy for the site, which includes performing upgrades, maintenance contracts, and changes. They will support and execute automation qualification and resolve all automation-related issues. The role requires updating and developing User Requirement Specifications, Functional Specifications, Design Specifications, and Operation and Maintenance documents for both new and existing control systems. The candidate will devise new approaches to complex problems through adaptations and modifications of standard automation technical principles and will work closely with various departments, including manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification, to manage a diverse portfolio of projects. Additionally, the candidate will lead, plan, and execute automation projects from start-up to completion, develop project commission plans and strategies, manage and resolve project deficiencies and deviations, and assist in preparing project initiation documents. They will provide technical support to operations and support personnel, own and close corrective actions related to the automation systems, and ensure compliance with technical, quality, and legal requirements, all while maintaining reliable runtime of automation systems with minimal downtime.

Responsibilities

  • Oversight of the automation systems at the site including building automation systems (BAS), room monitoring systems (RMS), process and laboratory equipment automation.
  • Oversight of the overall automation asset care strategy for the site which includes performing upgrades, maintenance contracts and changes.
  • Support and execute automation qualification as well as resolve all automation-related issues.
  • Ensure cGMP, Data Integrity, and CSV compliance with all internal Novartis and external regulatory requirements.
  • Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, Operation and Maintenance for the new and existing control systems.
  • Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
  • Work closely with manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification to manage a diverse portfolio of projects.
  • Lead, plan, and execute automation projects from start-up to completion.
  • Develop Project Commission Plan / Strategy.
  • Manage and resolve project deficiencies and deviations.
  • Develop project execution strategy and execute project(s) according to customer needs (costs, schedule, functionality, quality).
  • Assist in Preparing Project Initiation Documents (Business Requirements (PBR), Work Breakdown Structure (WBS); Cost Breakdown Structure (CBS), Project Scope Statement (PSS).
  • Provide technical support to operations and support personnel.
  • Own and close corrective actions related to the automation systems.
  • Ensure compliance with technical, quality and legal requirements.
  • Maintain reliable runtime of automation systems (minimum downtime).

Requirements

  • Bachelor's degree in engineering, computer science, automation, or related field or equivalent relevant experience.
  • 2+ years of relevant engineering experience in Chemical, Pharmaceutical or Food & Beverage industry is required.
  • Good oral and written communication skills.
  • Knowledge of FDA regulations, particularly 21 CFR part 11 and GMP systems.
  • Familiarity with industry standards 21 CFR Part 11, Data Integrity, Validation, and GAMP.
  • Extended interdisciplinary technical knowledge, particularly in a GMP regulated environment (pharmaceutical preferable).
  • Experience with automation systems (Continuum, Siemens, DeltaV, PLCs, etc).
  • Knowledge of IT infrastructure/networks related to automation systems.
  • Strong computer skills and ability to work well with others in a team environment.
  • Working knowledge of P&ID and loop diagram standards; temperature, pressure, flow, weight, humidity, and other instrumentation.

Benefits

  • Sign-on bonus
  • Restricted stock units
  • Discretionary awards
  • Full range of medical benefits
  • 401(k) eligibility
  • Various paid time off benefits, such as vacation, sick time, and parental leave.
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