Senior Digital Quality Engineer

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

Seeking an experienced Senior Digital Quality Engineer to support GxP quality oversight and computerized system validation within a leading global biopharmaceutical organization. This is a hands-on opportunity for a quality and validation professional to oversee the lifecycle management of enterprise, clinical, and laboratory systems, ensuring compliance with global regulatory requirements and data integrity standards.

The ideal candidate will bring at least 7 years of GxP computerized system validation experience within the pharmaceutical or biotechnology industry, strong knowledge of FDA and EU regulations, and hands-on experience implementing risk-based validation strategies. Experience supporting AI/ML-enabled GxP systems is highly desirable as the organization continues expanding its digital capabilities.

Key Responsibilities

• Lead and support end-to-end GxP computerized system validation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, IQ/OQ/PQ protocols, Traceability Matrices (RTM), and Validation Summary Reports (VSRs).
• Apply risk-based validation approaches in alignment with FDA Computer Software Assurance (CSA) principles and ISPE GAMP 5 guidance.
• Maintain validation lifecycle documentation for enterprise GxP systems, including Veeva Vault Quality, Veeva Medical, Veeva RIM, ServiceNow, and TraceLink.
• Support validation and quality oversight of clinical systems, including EDC, IRT, eCOA, eTMF, and CTMS, as well as laboratory systems such as LIMS, CMMS, and EMS.
• Evaluate change controls, determine revalidation requirements, conduct periodic reviews, and maintain systems in a validated state throughout their lifecycle.
• Author, review, and approve GxP documentation, including SOPs, Work Instructions, and validation deliverables, ensuring compliance with ALCOA+ data integrity principles.
• Support validation and quality oversight of AI/ML-enabled GxP systems, including intended use documentation, risk assessments, acceptance criteria, and model lifecycle controls.
• Establish and evaluate AI model testing controls, including test data independence, input sample space characterization, performance monitoring, and drift detection.
• Develop and maintain human-in-the-loop (HITL) oversight procedures for AI-assisted GMP decisions, including reviewer qualifications, review documentation, and monitoring processes.
• Conduct supplier qualification assessments for GxP system vendors, including review of audit reports, vendor questionnaires, Quality/Technical Agreements, and validation documentation.
• Evaluate AI/ML vendor documentation related to model training, validation, testing, and data independence practices.
• Maintain computerized systems in a constant state of inspection readiness and serve as a subject matter expert during FDA, EMA, and other regulatory inspections.

Required Skills

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related scientific or technical discipline; advanced degree preferred.
• Minimum 7 years of GxP computerized system validation experience within the pharmaceutical or biotechnology industry.
• Demonstrated experience managing the end-to-end validation lifecycle of enterprise, clinical, and/or laboratory systems.
• Strong understanding of 21 CFR Part 11, EU Annex 11, electronic records, electronic signatures, audit trails, and access controls.
• Strong working knowledge of ISPE GAMP 5 principles, including software categorization, risk-based validation, and supplier assessments.
• Practical experience applying FDA Computer Software Assurance (CSA) guidance and developing risk-based validation strategies.
• Hands-on experience validating enterprise GxP systems, particularly Veeva Vault, ServiceNow, Qlik, or Entra ID.
• Working knowledge of clinical systems (EDC, IRT, eTMF, CTMS) and/or laboratory systems (LIMS, CDS, ELN).
• Experience validating on-premise, SaaS, and cloud-hosted computerized systems.
• Experience supporting regulatory inspections, audit readiness, and computerized system compliance.
• Strong understanding of quality systems processes, including Change Control, Deviation Management, CAPA, and Supplier Quality.

Preferred Qualifications

• Experience supporting GxP validation or quality oversight of AI/ML-enabled computerized systems.
• Familiarity with EMA Draft Annex 22 and evolving regulatory expectations for AI/ML applications in GxP environments.
• Experience with AI model classification, criticality assessments, intended use documentation, and model lifecycle controls.
• Knowledge of test data independence requirements, acceptance criteria, model performance monitoring, and input sample space drift detection.
• Experience evaluating AI/ML vendor validation documentation and supplier quality controls.
• Familiarity with explainability assessment tools and techniques, including SHAP values, LIME, and heat maps.
• Demonstrated ability to improve validation processes, strengthen documentation practices, and support digital quality initiatives.