Validation Specialist

ARC-One Solutions

. Serve as the validation subject matter expert for an Agile Team by providing business workflow clarification, validation guidance and regulatory context.

Posted 11/6/2026full-timeRemote • United StatesMid-LevelSenior💰 $61,492 - $96,630 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in validation processes and Agile methodologies, with a strong focus on developing risk-informed test scenarios and acceptance criteria. Proficient in collaborating with cross-functional teams to ensure quality assurance and compliance in regulated environments.

Highest-signal resume keywords

Validation Subject Matter ExpertAgile MethodologiesRisk-Based TestingSoftware Verification and ValidationFDA-Regulated Quality Expectations

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Behavior-Driven DevelopmentTest Scenario DevelopmentUser Story CreationAcceptance Criteria DevelopmentDefect ManagementChange Impact AssessmentExploratory TestingQuality Assurance MethodologiesTraceabilityRegulatory Compliance

Soft Skills

Analytical SkillsFacilitation SkillsCollaboration SkillsCommunication SkillsProblem-Solving Skills

Certifications & Qualifications

SAF(e) Agile Certification

Industry Keywords

Regulated Quality AssuranceBlood Bank EnvironmentQuality System ProceduresSOP ComplianceSoftware Development Life Cycle

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Serve as the validation subject matter expert for an Agile Team by providing business workflow clarification, validation guidance and regulatory context.
Develop behavior-driven development scenarios and support automated and manual test coverage aligned with acceptance criteria, intended use, applicable standards and industry practices.
Clarify documented business processes, user workflows, dependencies, risks and acceptance criteria when the Product Owner is unavailable, escalating decisions requiring formal Product Owner accountability.
Participate in and facilitate PI planning, backlog refinement, iteration planning, reviews, retrospectives and other Agile ceremonies.
Proactively prevent defects by embedding quality at the source and incorporating validation, risk, regulatory, traceability and testability considerations early in development.
Review user stories, defects, features, enablers and other work items to ensure appropriate acceptance-criteria and test-scenario coverage.
Collaborate with Product Managers, Product Owners, Agile team members and other stakeholders to ensure work supports intended use and agreed business value.
Create and refine user stories, defects, acceptance criteria and test scenarios from a software verification and validation perspective.
Develop risk-informed test scenarios covering representative use, normal and exception workflows, and negative and boundary conditions.
Support automated testing, review test output and confirm results are complete, objective and acceptable across applicable environments.
Drive clear, testable and risk-informed acceptance criteria for user stories and defects.
Perform ad hoc and workflow-based exploratory testing to identify defects, requirement ambiguity, workflow conflicts, validation gaps and documentation concerns.
Support validation planning, documentation, review, execution and evidence retention in accordance with quality system procedures.
Promote quality, inspection readiness, shared ownership and continuous improvement while mentoring cross-functional team members on validation expectations.

Requirements

What you’ll need

Bachelor’s degree from an accredited college or university.
Five (5) years of experience in regulated quality assurance, a blood bank environment, software testing, business analysis, validation, or an equivalent combination of education, training, and experience.
SAF(e) Agile certification, training, or practical Agile team experience preferred.
Experience supporting Agile teams through PI planning, backlog refinement, iteration planning, user story creation, acceptance criteria development, and test scenario review preferred.
Ability to analyze and document complex business processes, user workflows, risks, and system behavior as user stories, acceptance criteria, and validation scenarios.
Ability to serve as a validation subject matter expert and provide clear guidance regarding blood bank workflow and user needs.
Working knowledge of software verification and validation practices, traceability, risk-based testing, defect management, change impact assessment, and objective evidence expectations in a regulated environment.
Knowledge of FDA-regulated software quality expectations, quality system procedures, SOP compliance, software development life cycle principles and quality assurance methodologies preferred.
Ability to evaluate user stories, defects, acceptance criteria and test evidence to determine whether validation coverage is adequate, traceable and objective.
Strong analytical, facilitation, collaboration, communication and problem-solving skills, including the ability to explain technical, regulatory and workflow concepts in clear, non-technical terms.
Ability to manage multiple priorities and remain flexible when sprint commitments, priorities or work direction change.
Must have reliable internet connection at all times.
Must be able to travel 10% of the time.