Senior Lab Instrument Validation Lead – GxP

Compunnel, Inc.; Highland Heights (KY); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading clinical research firm in Kentucky is seeking a Senior Lab Instruments Software Validation Analyst. This role requires over 10 years of experience in laboratory instrument validation, ensuring compliance with FDA regulations and leading validation projects. The ideal candidate will possess strong leadership and technical writing skills, along with deep knowledge of risk assessment and quality assurance procedures.

Qualifications

• 10+ years of progressive experience in laboratory instrument and software validation.
• 5+ years of hands-on expertise in equipment qualification (DQ, IQ, OQ, PQ).
• Strong leadership skills to manage multiple validation projects.

Responsibilities

• Lead and execute validation protocols for analytical instruments and software.
• Design and implement testing strategies.
• Ensure compliance with FDA and international standards.

Skills

Analytical instrument validation

Regulatory compliance (FDA 21 CFR Part 11)

Risk assessment

Leadership

Cross-functional collaboration

Technical writing

Job description

A leading clinical research firm in Kentucky is seeking a Senior Lab Instruments Software Validation Analyst. This role requires over 10 years of experience in laboratory instrument validation, ensuring compliance with FDA regulations and leading validation projects. The ideal candidate will possess strong leadership and technical writing skills, along with deep knowledge of risk assessment and quality assurance procedures.