Validation Engineer: cGMP, CQ & Compliance Lead

Elanco; Kansas; On-site; USD 85,000 - 120,000; Full time

Job summary

Elanco is seeking a Validation Engineer for the Elwood, KS facility. You will coordinate commissioning, qualification, and requalification of facilities, utilities, equipment, and computerized systems to meet cGMP standards.

You’ll draft and review CQV plans and reports, perform risk analyses, and support regulatory audits. The role requires a Master’s degree in IT/CS or related field and 2+ years of experience in validation and regulatory compliance, with hands-on familiarity with Aveeva PI,

Qualifications

• Master’s degree in Information Technology, Computer Science, or related field plus 2 years’ experience required.

Responsibilities

• Coordinate commissioning, qualification, and requalification activities for facilities, equipment, and systems to meet cGMP standards.
• Prepare and review CQV documentation, ensuring accuracy, completeness, and regulatory compliance.
• Identify quality issues, perform root cause analysis, and implement CAPAs within the QA system.
• Provide technical input on facility/equipment modifications and support audits by regulators.

Skills

Regulatory knowledge

Technical writing

Data analysis

Problem solving

Risk management

Education

Master’s degree in IT/CS or related field

Tools

Aveeva PI

Ellab Suite

SAP

Site BMS

JMP

Job description

Elanco is seeking a Validation Engineer for the Elwood, KS facility. You will coordinate commissioning, qualification, and requalification of facilities, utilities, equipment, and computerized systems to meet cGMP standards.

You’ll draft and review CQV plans and reports, perform risk analyses, and support regulatory audits. The role requires a Master’s degree in IT/CS or related field and 2+ years of experience in validation and regulatory compliance, with hands-on familiarity with Aveeva PI,