Senior Digital Quality Engineer: GxP & AI/ML Validation

Meet Life Sciences Ltd.; Bridgewater Township (NJ); On-site; USD 120,000 - 190,000; Full time

Job summary

Meet Life Sciences Ltd. seeks an experienced Senior Digital Quality Engineer to support GxP quality oversight and computerized system validation across enterprise, clinical, and laboratory systems in a leading global biopharmaceutical organization.

The ideal candidate will bring 7+ years of GxP CVS experience within pharma/biotech, strong knowledge of FDA/EU regulations, and hands-on risk-based validation strategies.

Qualifications

• 7+ years of GxP computerized system validation experience in pharma/biotech.
• Experience managing end-to-end validation lifecycle for enterprise, clinical, and laboratory systems.
• Strong understanding of 21 CFR Part 11, EU Annex 11, electronic records, e-signatures, audit trails, and access controls.
• Hands-on experience with enterprise GxP systems such as Veeva Vault, ServiceNow, Qlik, Entra ID.

Responsibilities

• Lead end-to-end GxP computerized system validation, including Validation Plans, URS, IQ/OQ/PQ, RTM, and VSRs.
• Apply risk-based validation per FDA CSA principles and ISPE GAMP 5 guidance.
• Maintain validation lifecycle documentation for enterprise GxP systems (Veeva Vault, Veeva Medical, Veeva RIM, ServiceNow, TraceLink).
• Support validation and quality oversight of clinical systems (EDC, IRT, eCOA, eTMF, CTMS) and laboratory systems (LIMS, CMMS, EMS).
• Evaluate change controls and revalidation requirements; maintain validated state.
• Author/review SOPs, WI, and validation deliverables ensuring ALCOA+ data integrity.
• Support AI/ML-enabled GxP systems, including use documentation, risk assessments, and model lifecycle controls.
• Establish AI model testing controls, data independence, and drift detection.
• Develop HITL oversight procedures for AI-assisted GMP decisions; monitor reviewer qualifications and documentation.
• Conduct supplier qualification assessments for GxP vendors; review audit reports, Q/TA, and validation documentation.
• Evaluate AI/ML vendor documentation on model training, validation, testing, and data independence.

Skills

GxP validation

Regulatory compliance

Risk-based validation

CSA FDA guidance

ISPE GAMP 5

AI/ML validation

QA documentation

Education

Bachelor degree in Life Sciences, CS, Eng

Advanced degree preferred

Tools

Veeva Vault

Veeva Medical

Veeva RIM

ServiceNow

TraceLink

Qlik

Entra ID

Job description

Meet Life Sciences Ltd. seeks an experienced Senior Digital Quality Engineer to support GxP quality oversight and computerized system validation across enterprise, clinical, and laboratory systems in a leading global biopharmaceutical organization.

The ideal candidate will bring 7+ years of GxP CVS experience within pharma/biotech, strong knowledge of FDA/EU regulations, and hands-on risk-based validation strategies.