Validation Specialist (NGS & Bioinformatics)

Job Title: Validation Specialist (NGS & Bioinformatics)

Work Location: Wake County, North Carolina

Summary:

Seeking a Validation Specialist to lead the integrated validation of Next-Generation Sequencing (NGS) assays and bioinformatics workflows. This role bridges analytical development and computational data analysis to support advanced therapeutic platforms.

Responsibilities:

• Develop and implement validation strategies for NGS assays, including mRNA sequence confirmation, vector genome identification, and plasmid identification.
• Assess insert integrity, detect mutations and rearrangements, and perform on-target/off-target analysis for gene editing platforms.
• Validate bioinformatics pipelines to ensure data integrity and analytical accuracy across computational workflows.
• Draft and execute IQ/OQ/PQ protocols for software and computational tools used in NGS analysis.
• Conduct gap assessments of digital infrastructure to align with industry best practices and regulatory standards.
• Establish and maintain harmonized documentation frameworks that integrate wet lab and bioinformatics outputs.
• Develop and manage integrated Validation Master Plans, risk assessments (FMEA), and traceability matrices for end-to-end workflow coverage.
• Oversee lifecycle management and change control strategies for analytical methods and bioinformatics pipelines.

Qualifications:

• Experience writing and revising Validation Master Plans, protocols, and reports.
• Proficiency in developing bioinformatics validation packages (URS, FS, IQ/OQ/PQ).
• Skilled in preparing risk assessments and regulatory readiness documentation.
• Ability to conduct internal training sessions on validated methods.
• Bachelor’s or Master’s degree in Molecular Biology, Bioinformatics, Genetics, or a related field.
• Significant experience in NGS assay validation within a GxP regulated environment.
• Strong understanding of CRISPR analysis, mRNA sequencing, and viral vector characterization.
• Proven ability to create inspection-ready documentation and uphold data integrity principles.
• Capable of translating complex technical validation data into clear regulatory briefings.

Published Category: Quality & Validation