QA Validation Engineer

Biomune - Lenexa, KS

Full-time - Mid Level

Lenexa, KS

Chemical Manufacturing

About the position

The QA Validation Engineer at Biomune Company, a part of Ceva Animal Health, 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.
• Conducts risk assessments to determine validation strategies and executes Re-qualification studies.
• Ensures proper maintenance and calibration of equipment used for qualification purposes.
• Supports the change control process for qualified and validated equipment.
• Troubleshoots and resolves issues impacting validated conditions.
• Provides input to and reviews User Requirements Specifications and standard operating procedures.
• Researches equipment and processes to establish testing parameters for validation requirements.
• Develops Validation Plans and Schedules.
• Works overtime, alternate shifts, and/or weekends as necessary to execute protocols.

Requirements

• Bachelor's or Master's Degree in Engineering, Biotechnology, Biology, Microbiology, Science or related field.
• 4 years of validation experience with a bachelor's degree or 2 years with a master's degree in a GMP-regulated industry.
• Experience with data logging equipment and instruments, aseptic processes, and technical writing.
• Hands-on experience in qualification of equipment such as refrigerators, freezers, incubators, and autoclaves.

Nice-to-haves

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

Benefits

• Health insurance
• 401k plan
• Paid time off
• Flexible scheduling
• Professional development opportunities