Validation Engineer

Your day-to-day will include:

• Coordinate the planning and execution of commissioning, qualification, and requalification activities for facilities, utilities, equipment, and computerized systems at the Elwood, Kansas mAb manufacturing facility, ensuring adherence to Elanco and regulatory standards.
• Collaborate with system owners to define user requirements, develop detailed operating procedures, and establish strategies for commissioning and qualification (C&Q).
• Prepare, execute, and review protocols and reports for commissioning, qualification, and validation, verifying that documentation is complete, accurate, and compliant with cGMP and regulatory standards.
• Identify quality issues, manage root cause analysis, and assign corrective and preventative actions within the quality management system to ensure standards are met.
• Provide technical input on facility and equipment modifications to align with the validation strategy and ensure regulatory compliance.
• Oversee the timely performance of qualification and verification activities, coordinating with project and validation master plans.
• Support compliance during audits by regulatory bodies and corporate teams, developing audit responses, and completing corrective actions as assigned.
• Contribute to departmental and project budgeting, maintaining 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 strictly to cGMP standards, promoting a "Safety First and Quality Always" approach, and completing required training to stay current with industry standards.
• Provide C&Q support to project teams, focusing on local and major capital projects from planning through to qualification.
• Participate in all phases of 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, to ensure consistency with project and quality objectives.
• Prepare change management plans and follow through with associated action items to maintain continuous improvement and quality control.

You have the following technical skills and qualifications:

• Master's degree in Information Technology, Computer Science, a related field, or a foreign equivalent plus 2 years of post-baccalaureate experience in job offered or any engineering related roles.
• 2 years of experience in regulatory knowledge and compliance across the FDA, GMP, and ISO frameworks.
• 2 years of experience in technical writing and documentation.
• 2 years of experience in validation protocols and methodology.
• 2 years of experience in data analysis and statistics including JMP, Ellab Suite, AVEVA PI.
• 2 years of experience in problem-solving and troubleshooting including root cause analysis tools: 5 Whys, Ishikawa Diagrams, and Pareto Charts.
• 2 years of experience in risk assessment (FMEA/Quality Risk Management).
• 2 years of experience in software/automation tools including AVEVA PI, site BMS, Ellab Suite, and SAP.