Validation Specialist
About The Position
The Validation Specialist serves as the software validation subject matter expert for an Agile team, translating business workflows, acceptance criteria, regulatory expectations, and risk considerations into clear, testable requirements and robust verification and validation coverage. The role partners with Product Owners, Product Managers, engineers, and other cross-functional stakeholders to support compliant software delivery in a regulated environment. The position supports Agile planning, test design and execution, traceability, defect identification and evaluation, and continuous improvement. It clarifies documented business processes and validation expectations when needed while escalating decisions requiring formal Product Owner accountability. The role also promotes quality, inspection readiness, shared ownership, and early consideration of validation and risk throughout the development lifecycle.
Requirements
- Bachelor’s degree from an accredited college or university.
- Five 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.
- 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.
- 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 a reliable internet connection at all times.
- Must be able to travel 10% of the time.
Nice To Haves
- SAFe Agile certification, training, or practical Agile team experience.
- Experience supporting Agile teams through PI planning, backlog refinement, iteration planning, user story creation, acceptance criteria development, and test scenario review.
- Knowledge of FDA-regulated software quality expectations, quality system procedures, SOP compliance, software development life cycle principles, and quality assurance methodologies.
Responsibilities
- Serve as the Agile Team’s validation subject matter expert 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, acceptance criteria, and regulatory considerations when the Product Owner is unavailable or when requested; escalate decisions requiring formal Product Owner accountability.
- Participate in and facilitate, as needed, PI planning, backlog refinement, iteration planning, reviews, retrospectives, and other Agile ceremonies.
- Review user stories, defects, features, enablers, and other work items before Product Owner review to assess acceptance criteria and test-scenario coverage and help prevent defects early.
- Collaborate with Product Managers, Product Owners, Agile team members, and others to ensure work items support 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 applicable negative and boundary conditions.
- Support automated testing, review test output, and confirm results are complete, objective, and acceptable across applicable environments.
- Drive development of clear, testable, risk-informed acceptance criteria for user stories and defects.
- Perform ad hoc and workflow-based exploratory testing throughout development to provide timely feedback and identify defects, 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, and mentor cross-functional team members on validation expectations.
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What This Job Offers
Job Type
Full-time
