Validation Engineer

Elanco•Elwood, KS

About The Position

The Validation Engineer coordinates commissioning, qualification, and requalification activities for facilities, utilities, equipment, and computerized systems at Elanco’s Elwood, Kansas mAb manufacturing facility, ensuring compliance with Elanco standards and applicable regulations. The role collaborates with system owners to define user requirements, develop operating procedures, and establish C&Q strategies, and prepares, executes, and reviews compliant protocols and reports. The position identifies quality issues, oversees root cause analysis and corrective and preventive actions, provides technical input on facility and equipment modifications, and supports qualification and verification activities in line with project and validation master plans. It also supports regulatory and corporate audits, contributes to budgeting, trains personnel, and serves as a subject matter expert on quality and validation standards. The engineer provides C&Q support throughout capital projects, from scope definition, design analysis, user requirements, and equipment selection through execution and qualification. Responsibilities also include developing and maintaining C&Q documentation, preparing change management plans, and following up on associated actions. The role requires adherence to cGMP and a “Safety First and Quality Always” approach.

Requirements

Master’s degree in Information Technology, Computer Science, a related field, or a foreign equivalent.
Two years of post-baccalaureate experience in the job offered or in any engineering-related role.
Two years of experience with regulatory knowledge and compliance across FDA, GMP, and ISO frameworks.
Two years of experience in technical writing and documentation.
Two years of experience with validation protocols and methodology.
Two years of experience in data analysis and statistics, including JMP, Ellab Suite, and Aveeva PI.
Two years of experience in problem-solving and troubleshooting, including root cause analysis tools such as 5 Whys, Ishikawa diagrams, and Pareto charts.
Two years of experience with risk assessment, including FMEA and Quality Risk Management, and contributing to or facilitating risk assessments and FMEAs for site systems.
Two years of experience with software and automation tools, including Aveeva PI, site BMS, Ellab Suite, and SAP.

Responsibilities

Coordinate planning and execution of commissioning, qualification, and requalification activities for facilities, utilities, equipment, and computerized systems.
Collaborate with system owners to define user requirements, develop operating procedures, and establish commissioning and qualification strategies.
Prepare, execute, and review commissioning, qualification, and validation protocols and reports.
Identify quality issues, manage root cause analysis, and assign corrective and preventive actions in the quality management system.
Provide technical input on facility and equipment modifications to support validation strategy and regulatory compliance.
Oversee timely qualification and verification activities in coordination with project and validation master plans.
Support regulatory and corporate audits, prepare audit responses, and complete assigned corrective actions.
Contribute to departmental and project budgeting.
Train personnel and serve as a subject matter expert on quality and validation standards.
Adhere to cGMP standards, promote a “Safety First and Quality Always” approach, and complete required training.
Provide C&Q support to local and major capital projects from planning through qualification.
Participate in capital project activities, including scope definition, design option analysis, user requirement specifications, equipment selection, and C&Q execution.
Act as a C&Q subject matter expert on project teams and relevant committees.
Create, review, and update C&Q documentation, including user requirements, plans, and protocols.
Prepare change management plans and follow through on associated action items.