Instrument Software Validation Analyst
Job Location:
Cincinnati, OH - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Location - Work from client office - 2110 East Galbraith Road Cincinnati OH 45237
End Date 31st Dec
Job Title: Instrument Software Validation Analyst
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
