Ecocareers ยท 2 months ago
Senior Lab Instruments Software Validation Analyst / Technical Writers
Highland Heights, KY
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expConfidential company is seeking an experienced Lab Instruments Software Validation Analyst with extensive expertise in the clinical research industry. The role focuses on ensuring the reliability, accuracy, and regulatory compliance of laboratory instrument software and computerized systems used in clinical trials, leading validation protocols and collaborating across teams.
Staffing & Recruiting
Responsibilities
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 Corrective and Preventive Actions (CAPA) are implemented
Collaborate with Quality Assurance, 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, foster knowledge sharing and best practices
Qualification
Required
10+ years of progressive experience in laboratory instrument and software validation within the clinical research, pharmaceutical, or biotechnology industry
5+ years of hands-on expertise in analytical instrument systems validation (e.g., spectroscopy, chromatography, protein analyzers, next-gen sequencers, PCR systems)
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 Assessment Documents, 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
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase