Senior Validations Specialist

Position Overview

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.

As a global company with a presence in the United States, the United Kingdom, and Australia, we operate as lean, hands-on teams where every role has real ownership and visible impact. This position suits someone who moves with urgency, approaches challenges with a solutions-first mindset, and enjoys the pace and variety that come with contributing to moderately complex aspects of projects both independently and collaboratively.

Accountabilities and Responsibilities

Validation and Verification

• 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 that they are in compliance with required quality guidelines.
• Drive validation activities to completion with urgency, proactively removing roadblocks and keeping stakeholders informed of progress and risks.

Bioinformatics Analysis and Interpretation

• 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.

Quality Control and Data Integrity

• 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 as they relate to validated systems and data.
• Write, review, and update standard operating procedures relevant to validation and quality control procedures in compliance with regulatory requirements.

Tools and Software Development

• Use a variety of bioinformatics tools and platforms; evaluate, select, and configure tools to fit business and scientific needs.
• Document tools, pipelines, and processes so that knowledge is shared and work is repeatable across the team.

Collaboration and Continuous Improvement

• Work independently on moderately complex aspects of projects while collaborating closely with laboratory, quality, and product teams.
• Contribute to a lean, efficient way of working by simplifying processes, eliminating redundant steps, and sharing improvements across teams.
• Bring energy, ownership, and a can-do attitude to cross-functional initiatives, helping the team move quickly without compromising quality.

Skills and Knowledge

• 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 and understanding 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 published by national and international accrediting programs (e.g., CLIA, CAP, COLA, NYSDOH, ISO 15189, ISO/IEC 17025, UKAS, etc.)
• 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 the resourcefulness to thrive in a lean, fast-moving environment

Experience

• Typically requires 4-7 years of related experience in bioinformatics, genomics data analysis, laboratory process validation and quality assurance, and/or regulatory compliance, within a laboratory or biotechnology setting
• Demonstrated ability to work independently and collaboratively, contributing to complex aspects of projects

Education

• Ph.D. or M.S. degree in Genetics, Bioinformatics, Computational Biology, or a related field required

Key Relationships / Stakeholder s

Internal Stakeholders

• Bioinformatics and Data Science teams
• Laboratory Operations
• Quality Assurance and Regulatory Affairs
• Research and Development / Product teams
• IT and Software Engineering

External Stakeholders

• Accreditation and regulatory bodies (e.g., CAP, CLIA) during audits and inspections
• Instrument, reagent, and software vendors
• External collaborators and reference laboratories, as required

Decision Making

Decisions this role makes alone

• Selection of analytical methods, statistical approaches, and bioinformatics tools for assigned work.
• Design details of validation and verification studies within approved protocols.
• Day-to-day prioritization and sequencing of tasks within assigned projects.
• Identification and escalation of data quality issues and validation risks.

Decisions this role makes under guidance or escalates

• Final acceptance and release of validated assays, pipelines, or systems (with Quality and management).
• Changes to SOPs, validated processes, or regulated workflows.
• Significant tool, software, or infrastructure purchases.
• Project scope, timeline, and resourcing changes.

Comprehensive 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.