Senior QA Validation Associate - GMP, CSV, Projects

elanco; Elwood (KS); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Relocation packages for eligible roles

9 Employee Resource Groups

Annual bonus offering

Up to 6% 401K matching

8-week parental leave

Job summary

Elanco is seeking a Sr. Associate, Quality Assurance Validation for its Elwood, Kansas monoclonal antibody manufacturing facility.

You will partner 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 role supports data integrity, regulatory readiness, and adherence to cGMP while backing the full lifecycle of capital and validation projects.

Qualifications

• Education: Bachelor’s degree in a science or engineering discipline.
• Experience: 5+ years in quality, engineering, or validation roles within biologics/pharma.
• Experience with equipment lifecycle management and CSV.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Provide Quality oversight for capital projects throughout the project lifecycle—from design through qualification and validation.
• Review and approve validation lifecycle docs; advise on qualification strategies to ensure compliance.
• Support CSV activities and improve data integrity across the site.
• Ensure compliance with cGMP; support internal audits and regulatory inspections; promote a Safety First and Quality Always culture.

Skills

Quality oversight

Cross-functional teamwork

Documentation review

Microsoft Office

Education

Bachelor’s degree in science/engineering

Tools

SAP

JMP

Veeva Vault

Job description

Elanco is seeking a Sr. Associate, Quality Assurance Validation for its Elwood, Kansas monoclonal antibody manufacturing facility.

You will partner 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 role supports data integrity, regulatory readiness, and adherence to cGMP while backing the full lifecycle of capital and validation projects.