Senior Lab Instruments Software Validation Analyst

Senior Lab Instruments Software Validation Analyst

Kentucky, Highland Heights

10/21/2025

Contract

Active

We are seeking an experienced Lab Instruments Software Validation Analyst with over 10 years of expertise in the clinical research industry, including a minimum of 5 years of hands‑on experience in analytical instrument/software validation and equipment qualification. This role ensures the reliability, accuracy, and regulatory compliance of laboratory instrument software and computerized systems used in clinical trials. The ideal candidate will have deep knowledge of GCP, GLP, cGMP, FDA 21 CFR Part 11, EU Annex 11, and strong leadership and cross‑functional collaboration skills.

• Lead and execute validation protocols (DQ, IQ, OQ, PQ) for analytical instruments and laboratory software
• Design and implement integration, regression, and performance testing strategies
• Oversee validation execution in GxP facilities, ensuring compliance with SOPs and international standards
• Author, review, and maintain validation life cycle documentation including URS, FRS, Traceability Matrix, Risk Assessments, Validation Summary Reports, SOPs, and technical specifications
• Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal policies
• Conduct periodic system reviews and manage revalidation activities
• Perform in‑depth risk assessments and gap analyses to mitigate compliance risks
• Lead investigations into deviations and ensure effective CAPA implementation
• Collaborate with QA, R&D, Production, IT, and global teams to deliver validation outcomes
• Partner with software/hardware development teams for issue resolution and debugging
• Mentor and train junior analysts, fostering knowledge sharing and best practices

• 10+ years of progressive experience in laboratory instrument and software validation within clinical research, pharmaceutical, or biotechnology industries
• 5+ years of hands‑on expertise in equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation
• Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5
• Risk assessment, root cause analysis, and CAPA management
• Validation documentation authoring and review (Validation Plans, URS/FRS, Risk Assessments, Traceability Matrices, Validation Summary Reports)
• Process improvement and SOP/work practice development in validation life cycle management
• Strong leadership skills with the ability to manage multiple validation projects simultaneously
• Excellent communication, technical writing, and collaboration skills across global teams