Senior Validations Specialist

About the Role

The Senior Validations Specialist is responsible for the analysis and interpretation of genetic data using computational and statistical methods, and for the validation activities that ensure our assays, pipelines, and data systems are accurate, reliable, and ready for use. Working with large-scale genomic data sets, this role identifies patterns and trends, implements quality control measures, and uses a variety of bioinformatics tools—developing new software applications where needed to solve problems in the field of genomics.

Responsibilities

• Design, execute, and document validation and verification studies for assays, bioinformatics pipelines, instruments, and data analysis workflows in line with regulatory and accreditation requirements.
• Define acceptance criteria, analyze validation data, and prepare clear, well-organized validation reports documenting the performance metrics of pipelines and products, ensuring compliance with quality guidelines.
• Drive validation activities to completion with urgency, proactively removing roadblocks and keeping stakeholders informed of progress and risks.
• Analyze and interpret large-scale biological and genomic data sets using computational and statistical methods.
• Identify patterns, trends, and anomalies in sequencing and genotyping data, and translate findings into actionable recommendations.
• Apply sound statistical rigor to study design, data analysis, and interpretation of results.
• Implement and maintain quality control measures to ensure the accuracy, reliability, and reproducibility of collected data.
• Monitor pipeline performance metrics, investigate deviations, and lead root-cause analysis with a solutions-first mindset.
• Support internal and external audits, inspections, and accreditation activities related to validated systems and data.
• Write, review, and update standard operating procedures relevant to validation and quality control procedures in compliance with regulatory requirements.
• Use, evaluate, select, and configure bioinformatics tools and platforms to fit business and scientific needs.
• Document tools, pipelines, and processes to ensure knowledge sharing and repeatability across the team.
• Work independently on moderately complex project aspects while collaborating with laboratory, quality, and product teams.
• Simplify processes, eliminate redundant steps, and share improvements across teams to contribute to a lean, efficient workflow.
• Bring energy, ownership, and a can-do attitude to cross-functional initiatives, helping the team move quickly without compromising quality.

Requirements

• Strong knowledge of bioinformatics tools, pipelines, software, and databases used in genomics (e.g., NGS and genotyping analysis workflows), including proficiency in Linux/UNIX environments.
• Working knowledge of molecular biology and genetic laboratory testing workflows.
• Proficiency in computational and statistical methods for analyzing large-scale biological data sets.
• Thorough knowledge of quality control principles, validation and verification practices, and regulatory standards (e.g., CLIA, CAP, COLA, NYSDOH, ISO 15189, ISO/IEC 17025, UKAS).
• Proven experience drafting technical validation plans, summary reports, and standard operating procedures in a regulated clinical laboratory environment.
• Clear written and verbal communication, with strong documentation habits.
• A sense of urgency, a solutions-first mindset, and resourcefulness to thrive in a lean, fast-moving environment.

Qualifications

• Typically requires 4–7 years of related experience in bioinformatics, genomics data analysis, laboratory process validation, quality assurance, and/or regulatory compliance within a laboratory or biotechnology setting.
• Demonstrated ability to work independently and collaboratively on complex project aspects.
• Ph.D. or M.S. degree in Genetics, Bioinformatics, Computational Biology, or a related field required.

Benefits

• Medical & Health Savings: Choice of 3 medical tiers generously sponsored by the company, with a monthly $50–$100 employer HSA contribution based on plan type and dependent level.
• 100% Covered Dental & Vision: No premium costs for employees or dependents.
• 401(k) Matching: Generous 50% company match up to 6% of annual base salary.
• Diverse PTO Framework: Structured time off incorporating vacation, sick leave, mental health days, personal days, company holidays, and a flexible floating holiday.
• Income Protection & Family Leave: Full company sponsorship of Short-Term and Long-Term Disability (STD/LTD) alongside Paid Family Leave offerings.