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Quality Assurance Validation Engineer

2 months ago

Lenexa, Kansas, United States Ceva Santé Animale Full time
Job Summary

The QA Validation Engineer will lead, design, perform, and report validation activities on processes, equipment, and systems used in the manufacture of regulated veterinary vaccines for domestic and international markets.

Key Responsibilities
  • Prepare and execute protocols for Cycle Development, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Engineering Studies (ES), Factory Acceptance Test (FAT), and Site Acceptance Test (SAT)
  • Coordinate the execution of qualifications and validation projects with other departments, including Operations, Engineering, Quality Control, and Quality Assurance
  • Perform or supervise the execution of protocols and maintain documentation as evidence of compliance with current Good Documentation Practices
  • Review, analyze, and compile protocol data and write reports for management review and approval
  • Perform and document risk assessments to determine validation strategy and approach
  • Execute Re-qualification (RQ) studies and periodic reviews to ensure equipment, systems, and processes maintain qualified and validated condition
Requirements
  • Bachelor's or Master's Degree in Engineering, Biotechnology, Biology, Microbiology, Science, or related field
  • 4-2 years of validation experience in the biotech, biological, pharmaceutical, or other GMP-regulated industry
  • Experience with data logging equipment and instruments, aseptic processes, technical writing, Microsoft Word and Excel, and qualification of equipment such as refrigerators, freezers, incubators, autoclaves, lyophilizers, bioreactors, fermenters, ovens, ampule filling machines, classified environments, media fills, sterilization processes, environmental monitoring, cleaning validation, process validation, and method validation
Working Conditions

M-F, 40 hours/week. Work overtime, alternate shifts, and/or weekends when necessary to execute protocols.