Validation Analyst

Limitlessli•Charlotte, NC

About The Position

We are seeking a Validation Analyst to support validation, quality, and compliance initiatives across a regulated operating environment. This role is responsible for developing and executing validation activities for equipment, technology solutions, business applications, and operational processes to ensure performance, reliability, and compliance with internal standards and applicable regulations.The ideal candidate will have experience working in quality-driven environments, managing validation documentation, supporting system implementations, evaluating operational risk, and collaborating with cross-functional teams to ensure successful project execution.

Requirements

Bachelor's degree in a technical, scientific, engineering, information systems, or related field.
3+ years of experience in a regulated or quality-focused environment.
2+ years of experience supporting validation, qualification, compliance, testing, or quality assurance activities.
Experience creating validation documentation, test protocols, and technical reports.
Strong analytical, organizational, and problem-solving skills.
Excellent written and verbal communication abilities.
Ability to manage multiple priorities with minimal supervision.

Nice To Haves

Experience supporting enterprise software applications, automated systems, or operational technologies.
Familiarity with risk assessment methodologies and change control processes.
Experience participating in audits, inspections, or compliance reviews.
Knowledge of validation lifecycle concepts and industry best practices.
Exposure to quality management systems and regulated business environments.
Detail-oriented and process-focused.
Strong collaborator who can work effectively across departments.
Comfortable interpreting technical requirements and translating them into practical testing strategies.
Able to balance compliance requirements with business objectives.
Self-starter with strong project management and organizational skills.
Committed to continuous improvement and operational excellence.

Responsibilities

Develop, execute, and maintain validation protocols, test plans, qualification documents, and summary reports.
Support validation activities throughout the lifecycle of equipment, systems, and business applications.
Analyze testing results and determine compliance with established acceptance criteria.
Investigate deviations, document findings, and support corrective actions.
Participate in periodic reviews and revalidation assessments as needed.
Ensure all validation activities comply with internal quality procedures and regulatory expectations.
Support validation efforts related to software applications, system enhancements, integrations, upgrades, and configuration changes.
Create and maintain testing documentation, requirements traceability, risk assessments, and validation deliverables.
Participate in user acceptance testing and implementation activities.
Evaluate proposed system changes and assess potential impact to validated environments.
Maintain validation documentation throughout the change management process.
Review performance data and provide recommendations regarding system suitability and operational readiness.
Support issue resolution efforts and assist with documentation related to quality events and investigations.
Monitor validation-related activities to ensure completion within established timelines.
Collaborate with internal stakeholders to identify and mitigate operational risks.
Participate in cross-functional projects involving quality, operations, technology, engineering, and business teams.
Review technical documentation, specifications, change requests, and implementation plans for completeness and compliance.
Support internal and external audits, inspections, and quality reviews.
Contribute to the development and continuous improvement of procedures, work instructions, and validation methodologies.
Provide guidance on validation practices and documentation standards.