Validation Engineer

At Elanco (NYCE: 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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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!

The Validation Engineer is responsible for design, development and execution of C&Q (Commissioning & Qualification) activities for facilities, utilities, and equipment at the Elwood, Kansas monoclonal antibody (mAb) manufacturing site.

The position is a subject matter expert with respect to commissioning and qualification activities and ensures that systems are delivered, operate and are maintained in a constant state of qualification across the asset lifecycle.

The Validation Engineer plays a key role in day-to-day operations as well as design and delivery of local and major capital projects on site.

Functions, Duties, Tasks:                                          

Commissioning & Qualification Support


* Provide leadership, coordination and support for planning and execution of commissioning, qualification and requalification activities of physical assets at the Elwood, Kansas mAb manufacturing facility including facilities, utilities, equipment, and computerized systems per Elanco and relevant regulatory expectations.


* Collaborate with system owners to define user requirements, develop operating procedures, and establish an appropriate C&Q strategy.


* Prepare, execute and review commissioning, qualification, and validation protocols / reports.

Ensure completeness, accuracy and conformance to applicable Elanco, cGMP and regulatory standards.


* Ensure issues are identified and captured in the relevant quality management system, and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned.


* Provide input on facility, utility, and equipment design and modifications to resolve issues and ensure compliance with validation strategy.


* Ensure qualification and verification activities are performed on schedule and in alignment with relevant project and validation master plans.


* Support internal, regulatory, or corporate audits to ensure compliance with domestic and international regulations, quality requirements, and guidance doc...