Title: Business Analyst
Location: Arden Hills, MN or Marlborough, MA
Salary: $110-125k.
No sponsorship available
Benefits:
health insurance
disability insurance
life insurance
retirement plans (like a 401(k))
paid time off (PTO) including vacation and sick days
Summary:
This position focuses on the execution of validation activities for software solutions that support quality and regulatory processes, including tools that incorporate artificial intelligence capabilities. The role is responsible for supporting validation efforts through documentation development, test execution, traceability management, and coordination with cross-functional stakeholders to ensure compliance with established software lifecycle and quality management practices.
Key Responsibilities - Prepare validation documentation including system purpose descriptions, validation plans, and test cases in alignment with internal governance and software lifecycle expectations.
- Execute validation testing activities, capturing evidence, documenting results, and tracking defects or issues identified during testing.
- Maintain traceability between system requirements, intended functionality, test cases, and validation outcomes.
- Assist with preparation and routing of change documentation related to validation deliverables.
- Work with quality, regulatory, and operational stakeholders to understand process workflows and convert them into testable system requirements.
- Incorporate user feedback into testing activities and validation documentation updates.
- Identify unclear or incomplete requirements and escalate issues to appropriate governance or project leads.
- Support validation readiness by coordinating system access, preparing test data, assisting with environment setup, and scheduling validation activities.
- Collaborate with technical teams, including developers, data specialists, and subject-matter experts, to ensure validation coverage and timely completion of activities.
- Participate in cross-functional discussions to clarify requirements, testing expectations, and validation outcomes.
- Ensure validation activities adhere to applicable internal procedures, documentation standards, and regulatory expectations.
- Maintain organized validation records to support audit readiness and compliance reviews.
- Contribute to continuous improvement of validation templates, documentation standards, and testing processes.
- Assist in developing standardized validation approaches to improve efficiency and consistency across projects involving advanced software tools.
- Track validation tasks and milestones across multiple projects and provide status updates to project leadership as needed.
Qualifications Required - At least 5 years of experience in software validation, quality engineering, or related roles within a regulated industry such as life sciences, healthcare technology, or pharmaceuticals.
- Strong understanding of validation documentation practices, including requirements traceability, test planning, test case development, and change management.
- Experience performing validation testing and producing documentation suitable for regulatory or internal audits.
- Ability to translate operational workflows and user needs into structured validation requirements and test cases.
- Strong written documentation skills and attention to detail with a focus on compliance.
- Ability to collaborate effectively with cross-functional teams including technical staff and process subject-matter experts.
- Analytical mindset with the ability to identify issues in requirements, documentation, or testing activities.
- Experience managing multiple validation tasks across concurrent projects.
- Familiarity with structured validation frameworks, procedures, and controlled documentation environments.
- Strong communication skills and ability to clearly present validation findings and documentation concerns.
- Ability to work independently within established governance and validation processes.
