Validation Specialist

Overview

The Validation Specialist serves as the software validation subject matter expert for an Agile team, helping translate business workflows, acceptance criteria, regulatory expectations, and risk considerations into clear, testable requirements and robust verification and validation coverage. This role partners with Product Owners, Product Managers, engineers, and other cross-functional stakeholders to support compliant delivery of software in a regulated environment. The position also supports agile planning, test design and execution, traceability, defect identification and evaluation, and continuous improvement while appropriately escalating decisions that require formal Product Owner accountability.

The base salary range for this position is $61,492-$96,630.

Actual pay will be determined based upon a candidate’s job-related knowledge, skills, education, experience, geographic location, and may include other job-related factors such as certification(s), professional licensure, or internal equity considerations.

Responsibilities

• Serves as the validation subject matter expert for the Agile Team by providing business workflow clarification, validation guidance and regulatory context.
• Develops behavior-driven development scenarios and supports the creation of automated and manual test coverage aligned with acceptance criteria, intended use, applicable standards and industry practices.
• Supports the team when the Product Owner is unavailable by clarifying documented business processes, user workflows, dependencies, risks and acceptance criteria while escalating decisions requiring formal Product Owner accountability.
• Participates and facilitates (as required) in PI planning, backlog refinement, iteration planning, reviews, retrospectives, and other Agile ceremonies needed to support timely delivery.
• Steps in for the Product Owner when requested to clarify business process expectations, user workflows, dependencies, risks, acceptance criteria, and regulatory considerations that affect committed work.
• Proactively helps to prevent defects by embedding quality at the source and incorporating validation, risk, regulatory, traceability and testability considerations early in the development lifecycle. Reviews user stories, defects, features, enablers and other work items before Product Owner review to ensure that acceptance criteria and associated test scenarios provide appropriate coverage and reduce the need for extensive downstream manual testing.
• Collaborates with Product Managers, Product Owners, Agile team members and others to ensure work items support intended use and agreed business value.
• Creates and refines user stories, defects, acceptance criteria, and test scenarios from a software verification and validation perspective.
• Develops robust, risk-informed test scenarios that address representative use, normal and exception workflows and applicable negative and boundary conditions.
• Supports automated testing, reviews test output and confirms that results are complete, objective and acceptable across applicable environments.
• Drives the development of clear, testable, and risk-informed acceptance criteria for user stories and defects.
• Performs ad hoc testing and workflow-based exploratory testing throughout the development cycle to provide timely feedback and identify defects, requirement ambiguity, workflow conflicts, validation gaps and documentation concerns.
• Supports validation planning, documentation, review, execution and evidence retention in accordance with quality system procedures. 
• Promotes quality, inspection readiness, shared ownership, and continuous improvement while mentoring cross-functional team members on validation expectations.

Qualifications

• 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.