Validation Specialist

Axiota US Inc•Wamego, KS

10h

About The Position

The Validation Specialist will support GMP quality control laboratory activities within a microbiology laboratory environment. This role combines hands-on microbiological testing with execution and maintenance of equipment, process, and analytical method validations. This is a bench-based role requiring daily work in a microbiology laboratory (e.g. culture handling, plating, microbial enumeration, environmental monitoring) in addition to validation documentation responsibilities. The position is execution-focused and requires strong technical laboratory competency.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry.
3+ years 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 experience in a microbiology-focused QC laboratory

Responsibilities

Perform routine microbiological testing in a GMP QC Laboratory, including but not limited to: Microbial plating and enumeration Culture handling and propagation Media preparation Environmental monitoring Aseptic technique and biosafety practices
Execute analytical method testing in accordance with approved SOPs and specifications
Assist with laboratory investigations, OOS/OOT events, and corrective actions.
Maintain laboratory equipment, calibration, and documentation.
Ensure compliance with GMP, GLP, safety, and quality system requirements.
Execute and document 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 and QC 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.