Sr. Associate, Quality Assurance Validation

About the role

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.

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.

Requirements

• 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).

Preferred qualifications

• 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).
• 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.