Senior Engineer, GxP Digital Systems QA & Validation

Planet Group; Bridgewater Township (NJ); Híbrido; USD 80.000 - 87.000; Tempo integral

Resumo da vaga

Planet Group seeks a Sr. Engineer, Digital Systems Quality Assurance (Contractor) to lead GxP validation of global digital systems. You will ensure compliance with 21 CFR Part 11, EU Annex 11, and CSA principles across enterprise and clinical platforms.

The role emphasizes AI-enabled validation, risk-based approaches, and rigorous documentation to support FDA and EMA inspections. Hybrid in Bridgewater, NJ with a 12-month contract.

Qualificações

• The candidate possesses a Life Sciences or IT-related degree and relevant GxP experience.
• 7+ years in GxP computerized system validation within FDA-regulated environments.
• Deep knowledge of 21 CFR Part 11, EU Annex 11, and CSA principles applied to validated systems.
• Strong familiarity with ISPE GAMP 5 and risk-based lifecycle validation.
• Experience validating enterprise GxP systems (e.g., QMS, LIMS, EDC, CTMS).
• Hands-on validation with AI/ML-enabled systems and model governance concepts.

Responsabilidades

• Lead or support end-to-end validation for GxP computerized systems per CSA and GAMP 5.
• Apply risk-based approaches to determine validation scope and resources.
• Maintain lifecycle documentation for enterprise and clinical systems.
• Evaluate change controls and perform periodic revalidations as needed.
• Author, review, and approve GxP documents ensuring ALCOA+ data integrity.
• Define acceptance criteria and ensure proper SME ownership for risk-based tests.
• Implement test data independence controls and audit trails.
• Assess whether model or system changes require retesting and document decisions.
• Track drift metrics for input space and model outputs per EMA/FDA expectations.
• Develop HITL oversight for AI-assisted GMP decisions and monitoring.
• Support explainability assessments during testing where applicable.
• Lead supplier qualification and audit readiness for GxP vendors.
• Review AI training and data independence documentation as part of supplier QA.

Conhecimentos

GxP validation

Regulatory compliance

21 CFR Part 11

GAMP 5

CSA guidance

Enterprise validation

Veeva Vault

ServiceNow

Clinical systems

AI/ML validation

Change control

Data integrity (ALCOA+)

Formação

Bachelor's degree in Life Sciences/Computer Science/Engineering

Ferramentas

Veeva Vault

ServiceNow

Qlik

Entra ID

Descrição da vaga

Planet Group seeks a Sr. Engineer, Digital Systems Quality Assurance (Contractor) to lead GxP validation of global digital systems. You will ensure compliance with 21 CFR Part 11, EU Annex 11, and CSA principles across enterprise and clinical platforms.

The role emphasizes AI-enabled validation, risk-based approaches, and rigorous documentation to support FDA and EMA inspections. Hybrid in Bridgewater, NJ with a 12-month contract.