Validation Engineer

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

• 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.

Requirement – 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. Relevant experience – Applicants must have 2 years of experience in the following: (1) Regulatory knowledge and compliance across the FDA, GMP, and ISO frameworks to systematically control, document, and continuously improve processes that produce safe, highly reliable products that consistently meet both strict legal mandates and international quality…