QA Validation Engineer

Ceva Sante Animale - Lenexa, KS

Full-time

Lenexa, KS

Professional, Scientific, and Technical Services

About the position

The QA Validation Engineer at Ceva Biomune in Lenexa, KS, is responsible for leading and executing validation activities for processes, equipment, and systems used in the manufacture of regulated veterinary vaccines. This role is crucial for ensuring compliance with regulatory standards and maintaining the quality of products intended for both domestic and international markets.

Responsibilities

• Prepares and executes validation protocols including Cycle Development, IQ, OQ, PQ, Engineering Studies, FAT, and SAT.
• Reviews protocol drafts and resolves conflicts to achieve management pre-approval.
• Coordinates the execution of qualifications with other departments such as Operations, Engineering, Quality Control, and Quality Assurance.
• Performs or supervises the execution of protocols and maintains documentation for compliance with Good Documentation Practices.
• Reviews, analyzes, and compiles protocol data and writes reports for management review.
• Conducts risk assessments to determine validation strategy and approach.
• Executes Re-qualification studies and periodic reviews to maintain qualified conditions.
• Ensures proper maintenance and calibration of equipment used for qualification.
• Supports change control processes for qualified equipment and systems.
• Troubleshoots and resolves issues impacting validated conditions.
• Provides input to and reviews User Requirements Specifications (URS).
• Writes, reviews, and edits standard operating procedures to align with validation requirements.
• Researches equipment and processes to establish testing parameters for validation.
• Supports the development of Validation Plans and Schedules.
• Works overtime, alternate shifts, and/or weekends as necessary to execute protocols.
• Ensures compliance with local, state, and federal regulations and CGMP standards.

Requirements

• Bachelor's or Master's Degree in Engineering, Biotechnology, Biology, Microbiology, Science or related field.
• For Bachelor's degree: 4 years of validation experience in the biotech, biological, pharmaceutical or GMP-regulated industry; for Master's degree: 2 years of experience.
• Experience with data logging equipment and instruments, aseptic processes, and technical writing.
• Hands-on experience in qualification of equipment such as refrigerators, freezers, incubators, autoclaves, and bioreactors.
• Knowledge of regulatory requirements such as USDA, cGMP's, and Eudralex.

Nice-to-haves

• Experience performing risk assessments, investigations, CAPA's, and Aseptic Process Simulations (APS or media fills).