Sr. Engineer, Digital Systems Quality Assurance (Contractor)

WhiteCap Workforce Solutions; Bridgewater Township (NJ); On-site; USD 96,000 - 165,000; Part time

Job summary

WhiteCap Workforce Solutions seeks a Senior Engineer, Digital Systems Quality Assurance (Contractor) to lead end‑to‑end GxP validation across enterprise, clinical and analytical systems in a regulated healthcare setting.

You will craft validation plans, URS, IQ/OQ/PQ, and VSRs in line with FDA CSA and ISPE GAMP 5 guidance.

Qualifications

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related field required; advanced degree preferred.
• Minimum 7 years of GxP computerized system validation experience in FDA-regulated environment.
• In-depth knowledge of 21 CFR Part 11 and Eudralex Annex 11 with electronic records, signatures, audit trails.
• Strong working knowledge of ISPE GAMP 5 and FDA CSA guidance for lifecycle validation.
• Hands-on experience with enterprise GxP systems (e.g. Veeva Vault, ServiceNow) and clinical/lab systems.
• Experience supporting AI/ML‑enabled system validation and regulatory inspections.

Responsibilities

• Lead or support end-to-end GxP system validation across enterprise, clinical, and lab domains.
• Apply risk-based validation to match system complexity and patient safety impact.
• Maintain validation lifecycle docs and ensure ALCOA data integrity.
• Author/review SOPs, validation deliverables, and acceptance criteria.
• Define test data independence controls and manage drift metrics for input space.
• Support supplier qualification and regulatory submissions during inspections.

Skills

GxP validation

Regulatory guidance

QA oversight

AI/ML governance

Risk-based validation

Education

Bachelor’s degree or higher

Tools

Veeva Vault

ServiceNow

Qlik

Entra ID

Job description

Our client, a leading healthcare organization, is looking for a Senior Engineer, Digital Systems Quality Assurance (Contractor) to start right away.

Location: Bridgewater, NJ

Responsibilities

• Lead or 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), in alignment with FDA CSA principles and ISPE GAMP 5 guidance.
• Apply risk-based validation approaches to right-size effort commensurate with system complexity, intended use, product quality, and patient safety impact.
• Maintain validation lifecycle documentation for Enterprise GxP systems (e.g. Veeva Vault Quality, Veeva Medical, Veeva RIM, ServiceNow, Tracelink), clinical systems (e.g. EDC, IRT, eCOA, eTMF), and analytical/lab systems (e.g. LIMS, CMMS, EMS — in compliance with 21 CFR Part 11 and EU Annex 11.
• Evaluate change control to determine revalidation scope, author periodic reviews for validated systems; and maintain the validated state throughout the system lifecycle.
• Author, review, and approve GxP documentation including SOPs, Work Instructions, and validation deliverables; ensure all documentation meets ALCOA data integrity principles.
• Author or review intended use documents with input sample space characterization; define risk-based acceptance criteria — no lower than the performance of the process being replaced — with process SME ownership; implement test data independence controls (access-controlled repository, audit trail, staff separation) to prevent hold‑out test set exposure during model development.
• Evaluate whether changes to the model, system, or physical inputs require retest and fully document any decision not to retest; define and track drift metrics for input sample space adherence and model output quality, escalating deviations per EMA Draft Annex 22 and FDA CSA expectations.
• Design and maintain HITL oversight procedures for AI‑assisted GMP decisions: define reviewer qualifications, author review SOPs, maintain per‑output records, and monitor operator agreement and override rates; support explainability assessments (e.g., SHAP values, LIME, heat maps) during acceptance testing where applicable.
• Conduct or support supplier qualification assessments for GxP system vendors, including review of audit reports, vendor questionnaires, Quality/Technical Agreements, and regulatory submission support documentation.
• For AI/ML vendor‑supplied models: assess supplier test data independence practices (access logs, repository controls, staff separation) and review vendor‑held training, validation, and testing documentation per regulated user obligations under Draft Annex 22 Section 2.2.
• Maintain the GxP computerized system portfolio in a constant state of inspection readiness; serve as subject matter expert during FDA, EMA, and other regulatory agency inspections covering computerized system validation.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field required; advanced degree preferred.
• Minimum 7 years of GxP computerized system validation experience in the FDA‑regulated pharmaceutical or biotechnology industry, with a demonstrated track record of end-to-end lifecycle management across enterprise, clinical, and/or laboratory systems.
• In-depth knowledge of 21 CFR Part 11 and Eudralex Volume 4 Annex 11, with practical experience applying electronic records, electronic signature, audit trail, and access control requirements to validated GxP systems.
• Strong working knowledge of ISPE GAMP 5 principles — including software categorization (Categories 1-5), risk‑based lifecycle validation, and supplier assessment — combined with demonstrated understanding of FDA Computer Software Assurance (CSA) guidance and right‑sized validation strategy definition.
• Hands‑on experience validating enterprise GxP systems; direct experience with one or more of the following strongly preferred: Veeva Vault (QMS, RIM, MedComms), ServiceNow (GxP modules), Qlik, or Entra ID.
• Working knowledge of Clinical Systems (e.g., EDC, IRT, eTMF, CTMS) and/or QC Laboratory Systems (e.g., LIMS, CDS, ELN) validation principles, including experience with on‑premise, SaaS, and cloud‑hosted system qualification.
• Experience supporting GxP validation or quality oversight of AI/ML‑enabled computerized systems, including familiarity with AI model classification (static vs. dynamic, deterministic vs. probabilistic) and criticality assessment based on direct impact to patient safety, product quality, or data integrity, in alignment with EMA Draft Annex 22.
• Working knowledge of AI model lifecycle controls, including intended use documentation with input sample space characterization, test data independence requirements (access‑controlled repositories, audit trail, staff separation), and acceptance criteria that are no lower than the performance of the process being replaced.
• Familiarity with human‑in‑the‑loop (HITL) oversight design for AI‑assisted GMP decisions and production monitoring concepts including input sample space drift detection; experience reviewing supplier‑held AI training, validation, and test data independence documentation as part of vendor qualification activities.
• Demonstrated experience supporting regulatory inspections and audit readiness activities.
• Experience with quality systems processes including Change Control, Deviation management, CAPA, and Supplier Quality.

Disclosure: The hourly rates and/or salaries listed may or may not reflect total compensation packages including bonus and fringe benefits, etc., nor are the advertisement(s) posted a guarantee of a certain compensation package for a position or bona fide offer of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.