Senior QA Validation Engineer - GMP Biotech

Ceva Santé Animale; Lenexa (KS); On-site; USD 90,000 - 120,000; Full time

Job summary

Ceva Animal Health, a global leader in animal health, seeks a QA Validation Engineer in Lenexa, KS to lead validation activities for vaccines and related processes. You will design, execute, and report on IQ, OQ, PQ, FAT/SAT, and ES while ensuring GDP compliance and regulatory alignment across domestic and international markets.

The role requires a Bachelor’s in Engineering/Biotech/Biology/Microbiology with several years of validation experience and strong knowledge of GMP, GLP, and GCP.

Qualifications

• Bachelor's degree with 4+ years of validation experience in biotech/pharma GMP-regulated industries.
• Master's degree with 2+ years of validation experience in biotech/pharma GMP-regulated industries.
• Ability to read, write, and communicate in English.
• Knowledge of GDP/GCP/GMP and regulatory requirements.

Responsibilities

• Prepare and execute validation protocols (IQ/OQ/PQ, FAT/SAT, ES).
• Review protocols, coordinate qualification with cross-functional teams.
• Maintain GDP-compliant documentation and generate reports for management.
• Perform risk assessments and support re-qualification studies.
• Support change control processes and CAPA investigations.
• Develop Validation Plans and Schedules; ensure CGMP compliance.

Skills

Auditing

Regulatory knowledge

Quality systems

English communication

Education

Bachelor's degree in Engineering/Biotech/Biology/Microbiology

Master's degree in Engineering/Biotech/Biology/Microbiology

Tools

Excel

Job description

Ceva Animal Health, a global leader in animal health, seeks a QA Validation Engineer in Lenexa, KS to lead validation activities for vaccines and related processes. You will design, execute, and report on IQ, OQ, PQ, FAT/SAT, and ES while ensuring GDP compliance and regulatory alignment across domestic and international markets.

The role requires a Bachelor’s in Engineering/Biotech/Biology/Microbiology with several years of validation experience and strong knowledge of GMP, GLP, and GCP.