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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.
Your 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.
What You Need to Succeed (minimum qualifications):
Education: Bachelor’s degree in a science or engineering discipline.
Experience: 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).
Top 2 Skills: 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).
What will give you a competitive edge (preferred qualifications):
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.
Additional Information:
Location: Elwood, Kansas (Onsite).
Day shift position. Weekend or evening work may occasionally be required to support operations.
Minimal travel required (<5%).
Full-time, permanent, salaried position.
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 you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
