Computer System Validation Engineer

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.
At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Computer System Validation Engineer (CSV) is part of the Manufacturing Engineering Team and is responsible for maintaining the validated and secure state of the operational technology (OT) environment. This role executes CSV and maintains the validated state of all OT platforms from initial installation through lifecycle management. Additional responsibilities include assisting with cybersecurity services for OT within the Elanco Elwood, KS site manufacturing environment.

The CSV Engineer will work with Process Engineers and Automation Engineers to support equipment integration into the larger site SCADA‑OT and Aveva PI Historian for data security and retrieval. The CSV Engineer will work with the corporate Info Sec (IT) team, the local Site Ops (IT) team, and corporate Automation Engineering teams to ensure CSV procedures and practices remain up to date.

The CSV Engineer will also work with the local Operations, Quality, Site Ops, and Engineering teams.

• Work with local and corporate OT to plan and implement the Elanco CSV program and assist with current cybersecurity requirements in Elwood, KS.
• Work with local and corporate Quality, Engineering, and IT Departments to ensure the validated and secure state of the OT environment.
• Development and execution of CSV test protocols for the implementation of new equipment and changes to site OT systems.
• Change control execution and oversight for administration and application support of OT software including Enterprise Aveva PI Historian and site Factory Talk View SE.

• BS Engineering, or equivalent (Majors in: Electronics Engineering, Automation Engineering, Manufacturing Engineering, Chemical Engineering, etc.) with minimum 2 years of experience working in a computer system validation role.
• Prior working experience in a regulated industry, for example FDA, EMA (EU GMP), Animal Health, Pharmaceutical or Biotech manufacturing environment.

• Prior working experience with Industrial Controls Systems (Rockwell or Siemens); familiarity with other programming software environments including Siemens TIA Portal, Mitsubishi, or Schneider Pac Drive programming software also beneficial.
• Experience with Rockwell Studio
  5000 and Factory Talk View SE Distributed and Local applications and programming environment.
• Experience working with historian databases, specifically Aveva PI and/or Rockwell Historian.
• Experience with industrial electrical controls including, but not limited to, VFDs, PLCs, HMIs, etc.

• Location: This role is at the Elanco Elwood Manufacturing Facility
• Schedule: This is a Monday – Friday dayshift role. Some night/weekend support may be required to meet demands of the 24‑hour manufacturing environment.
• The manufacturing equipment at the Elwood facility is in a cleanroom environment, which requires strict adherence to cleanroom gowning, sterility, and GxP requirements. Occasional/weekly access to these areas to support industrial workstations and Windows HMIs’ software may be necessary.
• This is a new, critical role for the Elanco Elwood facility, shaping the future for compliant and secure OT systems. This position offers an excellent opportunity for you…