Validation Engineer - cGMP & Regulatory Expert

Kansas Ag Connection; Kansas; On-site; USD 90,000 - 130,000; Full time

Job summary

Elanco, a global leader in animal health, is seeking a Validation Engineer at the Elwood, KS facility. You will coordinate commissioning, qualification, and validation activities for facilities, utilities, equipment, and computerized systems in compliance with cGMP and regulatory standards.

The role requires a Master's degree in IT/CS or related field with 2 years of experience in regulatory, validation methodologies, data analysis, and risk management.

Qualifications

• Master's degree in Information Technology, Computer Science, or related field plus 2 years of post-baccalaureate experience.
• Regulatory knowledge across the FDA, GMP, and ISO frameworks to systematically control, document, and continuously improve processes.
• Technical writing and documentation to produce specialized information into clear, accurate, and user-friendly materials.
• Validation Protocols & Methodology to prove systems meet specifications and regulatory standards.
• Data Analysis and Statistics including JMP, Ellab Suite, Aveeva PI.
• Problem-Solving and Troubleshooting including 5 Whys, Ishikawa Diagrams, and Pareto Charts.
• Risk Assessment (FMEA/Quality Risk Management) including creating risk assessments and FMEAs.
• Software/Automation Tools including Aveeva PI, site BMS, Ellab Suite, and SAP.

Responsibilities

• Coordinate commissioning, qualification, and requalification activities for facilities, utilities, equipment, and computerized systems.
• Prepare, execute, and review protocols and reports for C&Q and validation.
• Identify quality issues and drive root-cause analysis and corrective actions.
• Provide technical input on facility/equipment modifications to align with validation strategy.
• Oversee timely qualification activities in line with project/master plans.
• Support audits and develop corrective actions as assigned.
• Contribute to budgeting and training to promote quality and compliance.

Skills

Regulatory knowledge

Technical writing

Validation protocols

Data analysis

Problem solving

Risk assessment

Software tools

Education

Master's degree in IT/CS or related field

Tools

Aveeva PI

Ellab Suite

JMP

SAP

Site BMS

Job description

Elanco, a global leader in animal health, is seeking a Validation Engineer at the Elwood, KS facility. You will coordinate commissioning, qualification, and validation activities for facilities, utilities, equipment, and computerized systems in compliance with cGMP and regulatory standards.

The role requires a Master's degree in IT/CS or related field with 2 years of experience in regulatory, validation methodologies, data analysis, and risk management.