Senior Associate-Quality Assurance (Validation) (Engineering)

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 Associate -Quality Assurance (Validation)

As a Senior Associate – Quality Assurance (Validation), you will be a part of a high performing quality team responsible for the quality oversight of engineering systems and capital projects at the Elwood, KS facility. In this role, you will be responsible for providing quality oversight and project team guidance for equipment qualification and computer systems. This role also includes the ownership of the site data integrity review system.  

Your Responsibilities

• Capital Projects: Provide quality assurance representative for select local capital project activities by participating as part of the project team(s) throughout the lifecycle of the project.

• Equipment Qualification: Provide qualification guidance for production equipment, laboratory instrumentation and related equipment. Perform reviews of validation system life cycle documents including User Requirements, Design Reviews, FAT/SAT documentation, IQ/OQ/PQ, design documents, reports and procedures.

• Computer System Validation: Become qualified as an Elanco certified CSQA. Provide guidance for computer system validation activities, including but not limited to participating in validation risk assessments, review of design documents, test plans and reports and periodic reviews of computer systems at the site. Oversee the site Data Integrity review program.

• Regulatory and Compliance: Ensure regulatory compliance with current Good Manufacturing Practices (GxP). Ensure all aspects within the qualification and validation lifecycles are with in regulatory and Elanco expectations. Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and Elanco policies and procedures.  Exemplify “Safety First and Quality Always” mind-set. Provide support to internal audits & regulatory inspections as needed.

What You Need to Succeed (Minimum Qualifications):

• Bachelor's degree in a science or engineering discipline.

• 5+ years' experience in quality, engineering, or validation roles in biologics/pharmaceutical industry.

• Experience in equipment qualification and computer system validation

• Demonstrated ability to work collaboratively and across multiple departments and organization levels.

What Will Give You the Competitive Edge (Preferred Qualifications):

• Previous experience with qualification of single use technology

• Previous experience with mAbs

• Experience with Quality Risk Management (QRM) and Quality by Design (QbD)

• Experience with SAP, JMP, Veeva Vault.

• Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status