Location
Cincinnati, Ohio, United States
Posted
May 06, 2026
Job Description
Job Description:
We are seeking an experienced Instrument Software Validation Analyst to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments. The role ensures systems operate reliably and remain in a validated state in accordance with FDA, EMA, and GxP requirements. This position acts as a bridge between technical software validation, testing, and regulatory compliance.
Responsibilities:
Software Validation & Compliance:
Documentation & Regulatory Support:
We are seeking an experienced Instrument Software Validation Analyst to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments. The role ensures systems operate reliably and remain in a validated state in accordance with FDA, EMA, and GxP requirements. This position acts as a bridge between technical software validation, testing, and regulatory compliance.
Responsibilities:
Software Validation & Compliance:
- Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines.
- Develop and execute validation protocols including IQ, OQ, and PQ.
- Ensure systems remain in a validated state throughout their lifecycle.
Documentation & Regulatory Support:
- ...