Validation Engineer

Uncountable Inc.; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

A technology company in the United States is seeking a Validation Engineer to ensure that software systems meet quality standards and regulatory requirements. The ideal candidate has a Bachelor's degree in a related field and experience in software validation or quality engineering. Responsibilities include planning validation activities, maintaining documentation, and collaborating with teams. Strong communication skills and attention to detail are essential for success in this role.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
• Experience in software validation, quality engineering, or QA in a regulated environment.
• Familiarity with SDLC concepts, Agile development, and software testing methodologies.
• Experience authoring and maintaining validation and quality documentation.
• Strong attention to detail and ability to manage multiple validation activities in parallel.
• Clear written and verbal communication skills.

Responsibilities

• Plan, execute, and maintain software validation activities.
• Author and maintain validation documentation.
• Review system requirements and design specifications.
• Execute and/or review functional, integration, regression, and user acceptance testing.
• Support change control activities by assessing validation impact and updating documentation as needed.
• Collaborate with Engineering and Product to identify risks early and ensure quality is built into the development process.
• Participate in audits and inspections by preparing documentation and supporting responses.
• Continuously improve validation processes, templates, and tools to increase efficiency and scalability.

Skills

Software validation

Quality engineering

Attention to detail

Communication skills

Software testing methodologies

Education

Bachelor’s degree in Engineering or Computer Science

Job description

About Uncountable

Uncountable builds software that helps R&D teams manage data, workflows, and experimentation at scale. Our platform is used by scientific and engineering teams across regulated and non-regulated industries, and quality, reliability, and compliance are core to how we build and ship product.

Role Overview

The Validation Engineer is responsible for ensuring that Uncountable’s software systems meet internal quality standards and applicable regulatory requirements. This role partners closely with Engineering, Product, and Quality to design, execute, and maintain validation activities throughout the software development lifecycle.

Key Responsibilities

• Plan, execute, and maintain software validation activities in accordance with company procedures and applicable regulations (e.g., GxP, FDA, ISO, as applicable).
• Author and maintain validation documentation, including validation plans, risk assessments, test protocols, test reports, and traceability matrices.
• Review system requirements, design specifications, and user stories to ensure they are testable and appropriately controlled.
• Execute and/or review functional, integration, regression, and user acceptance testing.
• Support change control activities by assessing validation impact and updating documentation as needed.
• Collaborate with Engineering and Product to identify risks early and ensure quality is built into the development process.
• Participate in audits and inspections by preparing documentation and supporting responses.
• Continuously improve validation processes, templates, and tools to increase efficiency and scalability.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field (or equivalent practical experience).
• Experience in software validation, quality engineering, or QA in a regulated or quality-focused environment.
• Familiarity with SDLC concepts, Agile development, and software testing methodologies.
• Experience authoring and maintaining validation and quality documentation.
• Strong attention to detail and ability to manage multiple validation activities in parallel.
• Clear written and verbal communication skills.

Preferred Qualifications

• Experience validating SaaS or cloud-based applications.
• Familiarity with GxP, 21 CFR Part 11, ISO 9001, or similar regulatory frameworks.
• Experience working with cross-functional teams in a fast-paced product environment.
• Prior experience supporting customer or internal audits.