Instrument Software Validation Analyst

Title: Instrument Software Validation Analyst

Location: Cincinnati OH (Onsite)

Type: Contract

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: Bachelors 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