Computer System Validation Engineer

Role Summary

The 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 is responsible for executing CSV and maintaining the validated state of all OT platforms from initial installation through lifecycle management. Additional responsibilities include assistance 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 InfoSec (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.

Responsibilities

• 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 oversite for administration and application support of OT software including Enterprise Aveva PI Historian and site FactoryTalk View SE.

Qualifications

• Required: 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.
• Required: Prior working experience in a regulated industry, for example FDA, EMA (EU GMP), Animal Health, Pharmaceutical or Biotech manufacturing environment.

Skills

• Preferred: Prior working experience with Industrial Controls Systems (Rockwell or Siemens) Familiarity with other programming software environments including Siemens TIA Portal, Mitsubishi, or Schneider PacDrive programming software.
• Preferred: Experience with Rockwell Studio5000 and FactoryTalk View SE Distributed and Local applications and programming environment.
• Preferred: Experience working with historian databases, specifically Aveva PI and/or Rockwell Historian.
• Preferred: Experience with industrial electrical controls including, but not limited to, VFDs, PLCs, HMIs, etc.

Education

• BS Engineering, or equivalent (Majors in: Electronics Engineering, Automation Engineering, Manufacturing Engineering, Chemical Engineering, etc.).

Additional Requirements

• Location: This role is at the Elanco Elwood Manufacturing Facility
• Schedule: This is a Monday ‚Äì Friday dayshift role. Some night/weekend support may be required to meet demands of the 24-hour manufacturing environment.
• Working in a cleanroom environment with strict adherence to gowning, sterility, and GxP requirements; occasional/weekly access to these areas may be necessary.
• This is a new, critical role for the Elanco Elwood facility, shaping the future for compliant and secure OT systems.