Sr. Associate, Quality Assurance Validation

Elanco Tiergesundheit AG; Elwood (KS); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Employee Resource Groups

Annual bonus

401K matching

Job summary

Elanco is seeking a Sr. Associate, Quality Assurance Validation in Elwood, Kansas. The role supports capital projects, commissioning, qualification, and computer system validation for a mAb manufacturing facility.

You will partner with engineering and cross-functional teams to ensure facilities and systems are designed, qualified, and maintained in compliance with regulatory requirements. You will review validation lifecycle documentation, guide strategies, oversee CSV activities, and promote

Qualifications

• Bachelor’s degree in science or engineering required.
• 5+ years in quality, engineering, or validation in biologics/pharma.
• Experience with equipment lifecycles and CSV (computer system validation).

Responsibilities

• Provide QA oversight for capital projects from design through qualification and validation.
• Support design, engineering, commissioning, and qualification of facilities, utilities, equipment, and computerized systems used in mAb manufacturing.
• Review and approve validation lifecycle documentation (UR, DQ, FAT/SAT, IQ/OQ/PQ, reports).
• Provide guidance on qualification/validation strategies to engineering and quality teams to ensure compliance.
• Support and oversee CSV activities and contribute to maintaining data integrity at the site.
• Drive continuous improvement and standardization of lifecycle documentation aligned with Elanco standards.
• Ensure compliance with cGMP and regulatory requirements; support audits/inspections.

Skills

Organizational skills

Communication skills

Cross-functional collaboration

MS Office

Education

Bachelor's degree (science or engineering)

Tools

SAP

JMP

Veeva Vault

Job description

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.

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: Multiple relocation packages for eligible roles 8-week parental leave 9 Employee Resource Groups Annual bonus offering Up to 6% 401K matching 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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.