Biologics QA Validation - Senior Associate

Elanco Tiergesundheit AG

Elwood (KS)

On-site

USD 90,000 - 120,000

Full time

6 days ago

Be an early applicant

Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

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.