Business Analyst: AI Validation
About The Position
Your responsibilities will include: Execute validation testing according to the applicable lifecycle (e.g., Gen AI lifecycle, GSM), including evidence capture, defect logging, and result documentation. Support preparation and routing of change-control documentation associated with validation deliverables. Collaborate with Quality and Regulatory process owners, SMEs, and end users to understand workflow needs and translate them into testable requirements. Coordinate validation readiness activities such as access, test data preparation, environment setup, and scheduling. Work closely with Quality Systems stakeholders, Data Scientists, Developers, Legal representatives, and Quality/Regulatory SMEs to ensure validation coverage and timely execution. Participate in cross-functional discussions to clarify requirements, test expectations, and validation outcomes. Support audit readiness by maintaining accurate, complete, and defensible validation packages. Assist in developing standardized test cases and documentation patterns to improve efficiency and consistency across AI validation projects. Manage concurrent validation tasks across multiple AI tools, providing updates to project managers as needed. Minimum of 5 years' experience in software validation, quality engineering, or validation roles in a regulated environment (medical device, pharma, biotech, or equivalent). Strong knowledge of validation documentation practices including requirements traceability, intended use, test case development, and change control. Demonstrated experience executing validation testing and preparing audit-ready documentation. Ability to interpret user workflows and translate them into testable requirements. Excellent documentation skills with strong attention to detail and compliance focus. Ability to collaborate effectively with Data Scientists, developers, Quality/Regulatory SMEs, and process owners. Strong analytical and problem-solving skills with the ability to identify and escalate documentation or testing gaps. Comfortable managing multiple validation tasks in parallel projects. Experience following structured validation lifecycles, SOPs, and WI-driven processes. Strong communication skills with the ability to explain test outcomes and documentation gaps clearly and concisely. Ability to work independently within defined governance and validation frameworks. Familiarity with AI/ML-enabled tools, automated systems, or algorithmic platforms (training can be provided). Experience with Gen AI lifecycle, GSM, or similar validation models. Understanding of Quality and Regulatory workflows in the medical device or life sciences industry.
Requirements
- Minimum of 5 years' experience in software validation, quality engineering, or validation roles in a regulated environment (medical device, pharma, biotech, or equivalent).
- Strong knowledge of validation documentation practices including requirements traceability, intended use, test case development, and change control.
- Demonstrated experience executing validation testing and preparing audit-ready documentation.
- Ability to interpret user workflows and translate them into testable requirements.
- Excellent documentation skills with strong attention to detail and compliance focus.
- Ability to collaborate effectively with Data Scientists, developers, Quality/Regulatory SMEs, and process owners.
- Strong analytical and problem-solving skills with the ability to identify and escalate documentation or testing gaps.
- Comfortable managing multiple validation tasks in parallel projects.
- Experience following structured validation lifecycles, SOPs, and WI-driven processes.
- Strong communication skills with the ability to explain test outcomes and documentation gaps clearly and concisely.
- Ability to work independently within defined governance and validation frameworks.
- Familiarity with AI/ML-enabled tools, automated systems, or algorithmic platforms (training can be provided).
- Experience with Gen AI lifecycle, GSM, or similar validation models.
- Understanding of Quality and Regulatory workflows in the medical device or life sciences industry.
Responsibilities
- Execute validation testing according to the applicable lifecycle (e.g., Gen AI lifecycle, GSM), including evidence capture, defect logging, and result documentation.
- Support preparation and routing of change-control documentation associated with validation deliverables.
- Collaborate with Quality and Regulatory process owners, SMEs, and end users to understand workflow needs and translate them into testable requirements.
- Coordinate validation readiness activities such as access, test data preparation, environment setup, and scheduling.
- Work closely with Quality Systems stakeholders, Data Scientists, Developers, Legal representatives, and Quality/Regulatory SMEs to ensure validation coverage and timely execution.
- Participate in cross-functional discussions to clarify requirements, test expectations, and validation outcomes.
- Support audit readiness by maintaining accurate, complete, and defensible validation packages.
- Assist in developing standardized test cases and documentation patterns to improve efficiency and consistency across AI validation projects.
- Manage concurrent validation tasks across multiple AI tools, providing updates to project managers as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
