Validation Specialist

Axiota US Inc • Wamego, KS

2d

About The Position

Job
Purpose: The Validation Specialist will be responsible for supporting GMP quality control laboratory activities while primarily executing and maintaining equipment, process, and method validation in compliance with applicable regulatory and internal quality requirements. This role is hands-on and execution-focused, supporting day-to-day QC operations and ensuring validation activities are properly documented, maintained, and audit-ready.

Requirements

• Bachelor’s degree in Biology, Chemistry, Microbiology, or related science field.
• 3+ years of experience in GMP environment (biotech, animal health, pharmaceuticals, or related).
• Hands-on experience executing validation activities (equipment, process, or method validation).
• Working knowledge of GMP documentation, change control, deviations, and CAPA.
• Strong attention to detail and ability to manage documentation-heavy workflows.
• Comfortable working in a small-to-mid-size manufacturing environment with evolving priorities.

Nice To Haves

• Supporting audits and regulatory inspections.
• Experience in animal health, fermentation, or biotechnology manufacturing environments.
• Developing, writing, and executing validation protocols in a GMP environment.
• Prior QC laboratory experience.

Responsibilities

• Execute, document, and maintain equipment, process and analytical method validations (IQ/OQ/PQ) in accordance with GMP requirements.
• Author and revise validation protocols, reports, and supporting documentation.
• Support risk-based validation activities and change control assessments.
• Maintain validation files and ensure validation status is current and audit-ready.
• Support investigations, deviations, and CAPAs related to validation activities.
• Partner with QA, Engineering, and Production to support validation activities associated with new equipment, process changes, and continuous improvement initiatives.
• Provide validation support during internal and external audits.
• Perform routine QC testing in accordance with approved methods, SOPs, and specifications.
• Support laboratory documentation and data review.
• Assist with laboratory investigations, OOS/OOT events, and corrective actions.
• Support maintenance of laboratory equipment, calibration, and documentation.
• Ensure compliance with GMP, GLP, safety, and quality system requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level