Sr. Associate, Quality Assurance Validation

Elanco•Elwood, KS

3d•Onsite

About The Position

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! Your Role: Sr. Associate, Quality Assurance Validation The Sr. Associate, Quality Assurance Validation serves as a key Quality representative supporting capital projects, commissioning, qualification, and computer system validation (CSV) activities at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. This role partners closely with engineering, validation, and cross-functional teams to ensure facilities, utilities, equipment, and systems are designed, qualified, and maintained in compliance with regulatory requirements. The position plays a critical role in ensuring data integrity, regulatory readiness, and adherence to cGMP standards while supporting the full lifecycle of capital and validation projects.

Requirements

Bachelor’s degree in a science or engineering discipline.
5+ years of experience in quality, engineering, or validation roles within the biologics or pharmaceutical industry.
Experience in equipment lifecycle management and computer system validation (CSV).
Strong organizational and communication skills with high attention to detail; ability to collaborate effectively across cross-functional teams and multiple organizational levels.
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).

Nice To Haves

Experience in materials management within USDA, FDA, or EMA regulated environments.
Demonstrated success leading cross-functional teams or projects.
Experience with SAP, JMP, and Veeva Vault systems.
Working knowledge of VICH, USDA, and/or EU GMP regulations for veterinary biologics.

Responsibilities

Provide Quality oversight for capital projects by actively participating as the QA representative throughout the project lifecycle, from design through qualification and validation.
Support the design, engineering, commissioning, and qualification of facilities, utilities, equipment, and computerized systems used in mAb manufacturing.
Review and approve validation lifecycle documentation, including User Requirements, Design Qualifications, FAT/SAT, IQ/OQ/PQ protocols, reports, procedures, and periodic reviews.
Provide guidance on qualification and validation strategies to engineering and quality teams to ensure compliance and consistency.
Support and oversee computer system validation (CSV) activities and contribute to maintaining and improving data integrity processes across the site.
Drive continuous improvement and standardization of equipment and system lifecycle documentation aligned with Elanco operational standards.
Ensure compliance with cGMP and regulatory requirements by performing Quality review and oversight of site documentation.
Support internal audits and regulatory inspections as needed, and promote a “Safety First and Quality Always” culture across all activities.