GMP Validation Engineer – Biotech & Vaccines

CEVA Logistics; Lenexa (KS); Hybrid; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Ceva Animal Health in Lenexa, KS seeks a QA Validation Engineer to lead validation activities for processes, equipment, and systems used to manufacture regulated veterinary vaccines for domestic and international markets.

You will design, execute, review protocols (IQ, OQ, PQ), perform risk assessments, support change control, and ensure GDP/GMP compliance while collaborating with Operations, Engineering, QA/QC, and Quality Assurance.

Qualifikationen

• Bachelor’s degree in Engineering, Biotechnology, Biology, or Microbiology with 4+ years of validation experience in GMP-regulated industry.
• Master’s degree in Engineering, Biotechnology, Biology, or Microbiology with 2+ years of validation experience in GMP-regulated industry.
• Experience performing validation activities and maintaining GDP/GMP compliant documentation.

Aufgaben

• Lead validation activities for processes, equipment, and systems.
• Design, execute, and review validation protocols (IQ/OQ/PQ, FAT, SAT).
• Perform risk assessments and support change control processes.
• Ensure CGMP compliance and continuous improvement.

Kenntnisse

Audit lead

Regulatory knowledge

Quality systems

Excel data validation

Data logging

Risk assessments

CAPA investigations

Ausbildung

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

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

Jobbeschreibung

Ceva Animal Health in Lenexa, KS seeks a QA Validation Engineer to lead validation activities for processes, equipment, and systems used to manufacture regulated veterinary vaccines for domestic and international markets.

You will design, execute, review protocols (IQ, OQ, PQ), perform risk assessments, support change control, and ensure GDP/GMP compliance while collaborating with Operations, Engineering, QA/QC, and Quality Assurance.