Senior 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.

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!

Your Role: Senior Validation Engineer

The Senior Validation Engineer will report to the Director of Manufacturing Engineering.

This position will conduct and manage commissioning and qualification efforts for equipment, utilities, and processes.  This position will consult with site technical services for process and cleaning validation.

Your Responsibilities:


* Lead all validation activities and maintain the validation master plan for the site.


* Manage and/or lead the validation team in all CQV activities to meet site goals and timelines.


* Create commissioning, qualification, and validation documentation such as, but not limited to, user requirement specification, design qualification, protocols, and final summary reports.


* Conduct commissioning, qualification, and validation per approved Elanco corporate standards and protocols.


* Collaborate with the system owner to define user requirements and establish an appropriate CQV strategy.

 


* Support quality systems such as change control, deviations, CAPA, audits, quality metrics, annual product review, and person in plant

What You Need to Succeed (minimum qualifications):


* Education: BA or BS degree in a scientific discipline, related field, or comparable experience.


* Experience: 5 years of experience in commissioning, qualification, and validation of cGMP or cGXP at an operational level supporting manufacturing in a pharmaceutical or biotech environment, is required.


* Prior experience related to equipment commissioning, qualification and validation is required. 


* Specific knowledge of biological and pharmaceutical cGMPs (USDA and EU) is required.


* Must have excellent verbal, written, interpersonal, and organizational and communication skills.

Additional Information:


* Location: Elwood, KS

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification.

At Elanco we are dedicated to building a diverse and inclusive work environment.

If ...