QA Validation Engineer – GMP Biotech Systems

CEVA SANTE ANIMALE; Lenexa (KS); On-site; USD 90,000 - 120,000; Full time

Job summary

Ceva Animal Health in Lenexa, KS is seeking a QA Validation Engineer to lead validation activities for vaccines in manufacturing. The role focuses on designing and performing IQ/OQ/PQ, FAT, SAT, and related studies, ensuring robust documentation and regulatory alignment.

You will collaborate with Operations, Engineering, QC and QA to maintain validated states and oversee GDP-compliant documentation while supporting continuous improvement and change control processes.

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Biology, or Microbiology with 4+ years of validation experience in a GMP-regulated industry.
• Master’s degree in Engineering, Biotechnology, Biology, or Microbiology with 2+ years of validation experience in a GMP-regulated industry.
• Ability to read, write clearly, and communicate in English.

Responsibilities

• Prepare and execute validation protocols (IQ, OQ, PQ, FAT, SAT) and related studies.
• Coordinate qualification execution with Operations, Engineering, QC, and QA.
• Review and document validation data; write reports for management review and approval.
• Perform risk assessments and re-qualification studies to maintain validated state.
• Support change control for qualified equipment, including refrigerators, freezers, incubators, autoclaves, lyophilizers, bioreactors, fermenters, ovens, ampule filling machines, and related systems.
• Provide input to URS and SOPs to align with validation requirements.
• Assist Engineering on FAT and SAT preparation and execution.
• Develop Validation Plans and Schedules; ensure CGMP compliance and identify improvement opportunities.

Skills

Audit leadership

GLP/GMP knowledge

Excel validation

Data logging

Risk assessments

CAPAs

Aseptic process simulations

Education

Bachelor’s degree in Engineering, Biotechnology, Biology, or Microbiology

Master’s degree in Engineering, Biotechnology, Biology, or Microbiology

Tools

N/A

Job description

Ceva Animal Health in Lenexa, KS is seeking a QA Validation Engineer to lead validation activities for vaccines in manufacturing. The role focuses on designing and performing IQ/OQ/PQ, FAT, SAT, and related studies, ensuring robust documentation and regulatory alignment.

You will collaborate with Operations, Engineering, QC and QA to maintain validated states and oversee GDP-compliant documentation while supporting continuous improvement and change control processes.