Validation Engineer

Elanco•Elwood, KS

21h

About The Position

The Validation Engineer coordinates commissioning, qualification, and requalification activities for facilities, utilities, equipment, and computerized systems at Elanco’s mAb manufacturing facility in Elwood, Kansas. The role ensures that activities and documentation comply with Elanco standards, cGMP, and applicable regulatory requirements, and provides C&Q support to local and major capital projects from planning through qualification. The position collaborates with system owners and project teams to define user requirements, develop procedures and C&Q strategies, and prepare, execute, review, and update plans, protocols, and reports. It provides technical input on facility and equipment modifications, supports audits and corrective actions, contributes to project budgeting, and trains personnel as a quality and validation subject matter expert. The role also supports change management, continuous improvement, 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 with 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 (FMEA/Quality Risk Management), including facilitating and contributing to 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 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, ensuring complete, accurate, compliant documentation.
Identify quality issues, manage root cause analysis, and assign corrective and preventative actions within the quality management system.
Provide technical input on facility and equipment modifications to align with validation strategy and regulatory requirements.
Oversee timely qualification and verification activities in coordination with project and validation master plans.
Support regulatory and corporate audits, including developing audit responses and completing assigned corrective actions.
Contribute to departmental and project budgeting in alignment with project requirements.
Train personnel and serve as a subject matter expert on quality and validation standards, promoting C&Q knowledge across the site.
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 specification, 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, C&Q plans, and protocols.
Prepare change management plans and complete associated action items to support continuous improvement and quality control.