Validation Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the validation subject matter expert for an Agile Team by offering clarification on business workflows, validation guidance, and regulatory context.

• Create behavior-driven development scenarios and facilitate both automated and manual test coverage that aligns with acceptance criteria, intended use, applicable standards, and industry practices.

• Provide clarification on documented business processes, user workflows, dependencies, risks, and acceptance criteria in the absence of the Product Owner, escalating decisions that require formal accountability from the Product Owner.

• Engage in and lead PI planning, backlog refinement, iteration planning, reviews, retrospectives, and other Agile ceremonies.

• Actively prevent defects by embedding quality at the source and incorporating considerations for validation, risk, regulatory requirements, traceability, and testability early in the development process.

• Examine user stories, defects, features, enablers, and other work items to ensure comprehensive acceptance criteria and test scenario coverage.

• Collaborate with Product Managers, Product Owners, Agile team members, and other stakeholders to ensure that work aligns with intended use and delivers agreed-upon business value.

• Generate and refine user stories, defects, acceptance criteria, and test scenarios from a software verification and validation perspective.

• Formulate risk-informed test scenarios that address representative use cases, normal and exceptional workflows, as well as negative and boundary conditions.

• Assist with automated testing, review test outputs, and verify that results are thorough, objective, and acceptable across relevant environments.

• Establish clear, testable, and risk-informed acceptance criteria for user stories and defects.

• Conduct ad hoc and workflow-based exploratory testing to unveil defects, ambiguities in requirements, conflicts in workflows, validation gaps, and documentation issues.

• Aid in validation planning, documentation, review, execution, and evidence retention in alignment with quality system procedures.

• Advocate for quality, inspection readiness, shared ownership, and continuous improvement while mentoring cross-functional team members on validation expectations.

⛳️ Requirements

• A Bachelor’s degree from an accredited college or university.

• A minimum of 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 experience with Agile teams is preferred.

• Experience in supporting Agile teams through PI planning, backlog refinement, iteration planning, user story creation, acceptance criteria development, and test scenario review is preferred.

• Ability to analyze and document intricate business processes, user workflows, risks, and system behaviors as user stories, acceptance criteria, and validation scenarios.

• Capability to function as a validation subject matter expert and provide clear guidance regarding blood bank workflows and user requirements.

• Proficient knowledge of software verification and validation practices, traceability, risk-based testing, defect management, change impact assessment, and expectations for objective evidence in a regulated environment.

• Familiarity with FDA-regulated software quality expectations, quality system procedures, SOP compliance, software development life cycle principles, and quality assurance methodologies is preferred.

• Ability to evaluate user stories, defects, acceptance criteria, and test evidence to determine whether validation coverage is sufficient, traceable, and objective.

• Strong analytical, facilitation, collaboration, communication, and problem-solving skills, including the ability to articulate technical, regulatory, and workflow concepts in clear, non-technical terms.

• Capacity to manage multiple priorities and maintain flexibility when sprint commitments, priorities, or work direction change.

• Must have a reliable internet connection at all times.

• Ability to travel up to 10% of the time.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and training.

• Flexible work arrangements and supportive work-life balance.