QA Validation Lead – Capital Projects & CSV

Elanco; Elwood (IL); On-site; USD 85,000 - 110,000; Full time

Job summary

Elanco, a global leader in animal health, is seeking a Sr. Associate, Quality Assurance Validation at our Elwood facility. You will provide QA oversight for capital projects, commissioning, qualification, and CSV activities to ensure facilities, utilities, equipment, and systems are compliant with regulatory requirements.

You will review validation lifecycle documents, guide qualification strategies, and support CSV initiatives to uphold data integrity and cGMP standards across the site.

Qualifications

• Bachelor’s degree in science or engineering required.
• 5+ years in quality, engineering, or validation roles in biologics/pharma.
• Experience with equipment lifecycle management and CSV.

Responsibilities

• Provide Quality oversight for capital projects across the project lifecycle, including design, qualification, and validation of facilities and systems used in mAb manufacturing.
• Review and approve validation lifecycle documentation (URs, IQ/OQ/PQ, FAT/SAT) and guide teams on qualification strategies.
• Support CSV activities and maintain data integrity processes site-wide; drive standardization of lifecycle documentation.
• Ensure compliance with cGMP and regulatory requirements; support internal audits and inspections; promote Safety First and Quality Always.

Skills

Organizational skills

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in science or engineering

Tools

Microsoft Office

SAP

JMP

Veeva Vault

Job description

Elanco, a global leader in animal health, is seeking a Sr. Associate, Quality Assurance Validation at our Elwood facility. You will provide QA oversight for capital projects, commissioning, qualification, and CSV activities to ensure facilities, utilities, equipment, and systems are compliant with regulatory requirements.

You will review validation lifecycle documents, guide qualification strategies, and support CSV initiatives to uphold data integrity and cGMP standards across the site.