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Added 7 mins ago
Senior Compiler Engineer - AI
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C/C++ and Python programming, with excellent software design skills, including debugging, performance analysis, and test design.
Added 24 mins ago
IC Test Engineer
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…opportunities and market trends that address unmet needs. As an IC Test Engineer, you will be joining a dedicated team of visionaries to innovate and deliver the next generation of high…
Added 31 mins ago
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Senior AI/ML Engineer
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- $120,100 to $214,500 USD / year
…challenges at enterprise scale? We are seeking a Senior AI/ML Engineer to design, build, and operationalize AI capabilities that drive decision-making, productivity, and innovation across…
Added 32 mins ago
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Engineer Aircraft Communications - Orlando FL
Military Spouse Jobs & VetJobs
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Added 40 mins ago
Data Center Technician II
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Added 48 mins ago
Senior Software Development Engineer in Test, ML
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Added 56 mins ago
Software Engineer TS/SCI CI Poly Required (Java/J2EE)
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Added 56 mins ago
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Added 1 hour ago
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- $80,000 to $131,000 USD / year
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Added 1 hour ago
Lead DevOps Engineer
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Added 1 hour ago
Forward Deploy Engineer Guatemala
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Added 1 hour ago
Engineer III, OverWatch Labs (Remote)
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Added 1 hour ago
Lead, IPTL Software Engineer (Optical Space Systems) : Sign-on bonus ($30K max)
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Added 1 hour ago
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Added 1 hour ago
Software Engineer Co-op (January 2027)
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The Software organization develops software applications, including integration and test on missiles, launchers, radars, naval systems, fire control and other complex systems. Our precision…
Added 1 hour ago
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Cybersecurity Architect
Fresenius Medical Care
Waltham, MA
- $137,000 to $229,000 USD / year
Ability to work in a group development environment as an application security engineer across software engineer, QA engineer and build/test/release engineer teams.
Added 1 hour ago
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- $95,000 to $100,000 USD / year
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Added 1 hour ago
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Added 1 hour ago
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Added 2 hours ago
ENGR TECH III (MATERIALS)
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To assist a civil engineer or an engineering technician of higher rank in the supervision of a staff of subordinate Engineering Technicians engaged in materials testing activities; to take…
Added 2 hours ago
ENGR TECH III (MATERIALS)
Department of Transportation
United States
To assist a civil engineer or an engineering technician of higher rank in the supervision of a staff of subordinate Engineering Technicians engaged in materials testing activities; to take…
Added 2 hours ago
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Staff Software Engineer, Edge Agent
Cribl, Inc
Denver, CO
- $170,000 to $220,000 USD / year
…thousands of machines with diverse configurations. As a Staff Software Engineer on the Edge team, you will be a go-to engineer for Windows, building and improving the experience of running…
Added 2 hours ago
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ICT Engineer III
Jobgether
Remote, United States
- $104,738 to $130,502.05 USD / year
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an ICT Engineer III based in the United States.

The Planet Group

Sr. Engineer, Digital Systems Quality Assurance

Bridgewater, NJ, United States

$58 to $63 USD / hour

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Job details

Pay: $58 to $63 USD / hour
Apply by: Dec 2, 2026
Posting language: English
Posted: Nov 2, 2026

Original job description

Sr. Engineer, Digital Systems Quality Assurance

12 months

Location: Bridgewater, NJ Hybrid

Pay range: $58-63/hr.

Position Summary

The Senior Associate, Digital Systems Quality Assurance (Contractor) is responsible for providing GxP quality oversight and hands-on validation support for a global portfolio of computerized systems and digital platforms. This role partners closely with IT, Digital Quality, and cross-functional business teams to ensure that enterprise GxP systems--including Quality Management Systems (QMS), clinical and laboratory systems, enterprise platforms, and emerging AI/ML-enabled applications--are validated, compliant, and operationally sound in accordance with 21 CFR Part 11, EU Annex 11, EMA Draft Annex 22, FDA Computer Software Assurance (CSA) principles, and ISPE GAMP 5 guidance.

This role will play a critical part in establishing and executing compliant validation practices for AI-enabled digital capabilities, ensuring that quality, patient safety, and data integrity are maintained in alignment with evolving regulatory expectations.

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 efforts based on 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, and TraceLink), clinical systems (e.g., EDC, IRT, eCOA, eTMF), and analytical/laboratory systems (e.g., LIMS, CMMS, EMS) in compliance with 21 CFR Part 11 and EU Annex 11.

• Evaluate change controls to determine revalidation scope, conduct periodic reviews of validated systems, and maintain validated status throughout the system lifecycle.

• Author, review, and approve GxP documentation, including SOPs, Work Instructions, and validation deliverables, ensuring compliance with ALCOA+ data integrity principles.

• Author or review intended-use documents with input sample space characterization; define risk-based acceptance criteria that meet or exceed the performance of the process being replaced, with process SME ownership.

• Implement test data independence controls, including access-controlled repositories, audit trails, and staff separation, to prevent hold-out test set exposure during model development.

• Evaluate whether changes to models, systems, or physical inputs require retesting and fully document decisions not to retest.

• Define and track drift metrics for input sample space adherence and model output quality, escalating deviations in accordance with EMA Draft Annex 22 and FDA CSA expectations.

• Design and maintain human-in-the-loop (HITL) oversight procedures for AI-assisted GMP decisions, including reviewer qualifications, review SOPs, per-output records, and monitoring of operator agreement and override rates.

• Support explainability assessments (e.g., SHAP values, LIME, and 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, including access logs, repository controls, and staff separation, and review vendor-held training, validation, and testing documentation in accordance with regulated user obligations under Draft Annex 22 Section 2.2.

• Maintain the GxP computerized system portfolio in a constant state of inspection readiness and serve as a subject matter expert during FDA, EMA, and other regulatory agency inspections involving computerized system validation.

Required Skills & Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field required; advanced degree preferred.

• Minimum of 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 EU EudraLex Volume 4 Annex 11, with practical experience applying electronic records, electronic signatures, audit trails, 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.

• Hands-on experience validating enterprise GxP systems. Direct experience with one or more of the following is 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 trails, and staff separation), and acceptance criteria that meet or exceed 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.

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More about this job

Skills

Quality assurance
Documentation
ServiceNow
EDC
LIMS
CMMS
EMS
Regulatory compliance
Good manufacturing practices
ML
Inspection
Computer science
Biotechnology
Qlik
Quality control systems

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