CSV & Validation Architect for Regulated Systems

Anovo; Memphis (TN); In loco; USD 110.000 - 140.000; Tempo pieno

Descrizione del lavoro

Anovo is seeking a Technical Validation Architect in Memphis, TN to own CSV strategy and execution for the Aperture platform, ensuring FDA Part 11 compliance, data integrity, and audit readiness. The role sits at cross-section of software engineering, QA, and regulatory affairs.

Responsibilities include IQ/OQ/PQ execution, CI/CD validation, risk-based scoping, and documentation. Travel and audits are part of the job, with a focus on empowering agile delivery within a GxP framework.

Competenze

• Bachelor''s degree required in a relevant field.
• 7+ years'' CSV experience in FDA-regulated environments.
• Deep knowledge of 21 CFR Part 11 and ALCOA+ data integrity.
• Hands-on authoring and execution of IQ/OQ/PQ protocols and validation summaries.
• Familiarity with GAMP 5 risk-based validation methodology.
• Understanding of modern SDLC/CI-CD with validation controls.

Mansioni

• Develop and maintain CSV master plan and validation strategy for Aperture and GxP systems.
• Assess architecture against 21 CFR Part 11 for electronic records, signatures, and audit trails.
• Author and execute IQ/OQ/PQ protocols and validation reports.
• Embed validation into CI/CD pipelines with validation-by-design controls.
• Define and validate audit trails and data integrity requirements.
• Lead risk assessments for scope and rigor using a GAMP 5 approach.
• Maintain change control processes aligned with Part 11 and agile delivery.
• Prepare URS, FRS, DDS, traceability matrices, and validation summaries.
• Serve as SME during audits and inspections; support client due-diligence.
• Train teams on validation requirements and data integrity; align IT validation with broader GxP program.
• Attend reliably and fulfill other duties as assigned.

Formazione

Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field

7+ years of CSV experience in FDA-regulated environments

21 CFR Part 11 and data integrity (ALCOA+)

IQ/OQ/PQ protocol authoring and execution

GAMP 5 risk-based validation methodology

SDLC and CI/CD with validation controls

Technical writing and documentation

FDA inspections or client audits support

Descrizione del lavoro

Anovo is seeking a Technical Validation Architect in Memphis, TN to own CSV strategy and execution for the Aperture platform, ensuring FDA Part 11 compliance, data integrity, and audit readiness. The role sits at cross-section of software engineering, QA, and regulatory affairs.

Responsibilities include IQ/OQ/PQ execution, CI/CD validation, risk-based scoping, and documentation. Travel and audits are part of the job, with a focus on empowering agile delivery within a GxP framework.