Software Validation Analyst

Job Title: Instrument Software Validation Analyst
Location -  Cincinnati, OH (Onsite working)

Overview
We are seeking an experienced Instrument Software Validation Analyst to ensure that laboratory, manufacturing, and embedded software systems operate reliably, compliantly, and in accordance with regulatory requirements (GxP/FDA/EMA). The role focuses on maintaining validated systems through structured validation processes (IQ/OQ/PQ) and serves as a bridge between technical software testing and regulatory compliance.

Key Responsibilities
Software Validation & Compliance
Validate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelines
Develop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Ensure systems remain in a validated state throughout their lifecycle
Documentation & Regulatory Support
Author and maintain validation documentation including:
Validation Plans and Reports
User Requirement Specifications (URS)
Functional/Design Specifications
Traceability Matrices
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards
System Analysis & Design
Gather and document system requirements
Develop software specifications and validation test cases
Create infrastructure diagrams and data flow documentation
Document current-state software configurations
Testing & Execution
Perform functional, integration, regression, and data integrity testing
Identify, document, and troubleshoot validation deviations
Conduct root cause analysis and collaborate with cross-functional teams to resolve issues
Risk & Change Management
Conduct risk assessments (e.g., FMEA) to identify and mitigate system risks
Support and implement change control procedures for software updates and enhancements
Transition legacy SOPs to updated IT software management SOPs

Required Qualifications
Education: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
Experience: 2–5+ years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices)
Required Skills & Competencies
Regulatory Knowledge
5+ years of strong understanding of:
FDA, EMA, and GMP regulations
21 CFR Part 11
GAMP 5 guidelines
Data integrity principles
Technical Expertise
3 to 5 years of experience with:
Laboratory systems such as LIMS
Chromatography Data Systems (e.g., Empower)
Familiarity with validation lifecycle and documentation standards
Core Competencies
Strong analytical and problem-solving skills
Excellent technical writing and documentation abilities
Attention to detail with a quality-focused mindset
Ability to work cross-functionally with IT, QA, and business teams
Preferred Qualifications
Experience in global regulatory environments
Exposure to instrument software in laboratory or manufacturing settings
Knowledge of SOP migration and system lifecycle management