Senior QA Validation Lead: Capital Projects & CSV

Elanco; Elwood (KS); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Multiple relocation packages for eligible roles

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Up to 6% 401(k) matching

Job summary

A global leader in animal health is seeking a Sr. Associate for Quality Assurance Validation at their Elwood, Kansas facility. This role requires overseeing capital projects, ensuring compliance with cGMP standards, and managing documentation for regulatory readiness. Candidates should possess a Bachelor’s degree in a science or engineering discipline and have over 5 years of relevant experience in quality roles. The position offers full-time employment with various benefits, including parental leave and 401(k) matching.

Qualifications

• 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).
• Experience in materials management within regulated environments.

Responsibilities

• Provide Quality oversight for capital projects throughout the project lifecycle.
• Review and approve validation lifecycle documentation.
• Support and oversee computer system validation (CSV) activities.
• Ensure compliance with cGMP and regulatory requirements.

Skills

Strong organizational skills

Communication skills

Attention to detail

Collaboration skills

Proficiency with Microsoft Office

Education

Bachelor’s degree in a science or engineering discipline

Tools

SAP

JMP

Veeva Vault

Job description

A global leader in animal health is seeking a Sr. Associate for Quality Assurance Validation at their Elwood, Kansas facility. This role requires overseeing capital projects, ensuring compliance with cGMP standards, and managing documentation for regulatory readiness. Candidates should possess a Bachelor’s degree in a science or engineering discipline and have over 5 years of relevant experience in quality roles. The position offers full-time employment with various benefits, including parental leave and 401(k) matching.