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Added 1 min ago
NN
General Engineer/ Physical Scientist
National Nuclear Security Administration
Los Alamos, NM
- $90,479 to $203,388 USD / year
The successful candidate for the General Engineer/Physical Scientist (QA position) will provide quality assurance technical expertise on all aspects of nuclear weapons components at a DOE…
Added 3 mins ago
Controls Engineer - Monroe Area
The Pivot Group Network
Monroe · Monroe, MI
Controls Systems Engineer, Manufacturing Engineer, Process Controls Engineer, Instrumentation and Controls Engineer, Automation Controls Specialist, Electrical Engineer, Automation…
Added 4 mins ago
J
Senior Information Security Engineer
Jobgether
Remote, United States
- $76.92 to $81.74 USD / hour
…steps. Our partner is looking for a Senior Information Security Engineer based in the United…
Added 6 mins ago
PLC Programmer - Coldwater Area
The Pivot Group Network
Coldwater · Coldwater, MI
Systems Integrator, Maintenance Technician, Controls Engineer, Automation Engineer, PLC Technician, Electrical Controls Technician, Instrumentation Technician, Automation Technician,…
Added 6 mins ago
Engineering Manager - Mount Clemens Area
The Pivot Group Network
Mount Clemens · Mount Clemens, MI
Direct daily engineering activities across process, equipment, and continuous improvement work.
Added 18 mins ago
VH
Boiler Plant Operator
Veterans Health Administration
Wilmington, DE
- $31 to $36 USD / hour
…Utilities Section under the direct supervision of the Utility Engineer in Wilmington, DE. The Boiler Plant Operator is a key position in maintaining the safe, uninterrupted operations of…
Added 18 mins ago
Construction Manager, GES NA, Design and Construction
Amazon.com Services LLC
Boston, MA · Austin, TX · Nashville, TN · Arlington, VA · New York, NY · Irving, TX · Houston, TX
- Seek sustainable, environmentally responsible solutions throughout the construction process in alignment with Amazon's building practices
Added 23 mins ago
AN
PRODUCTION CONTROLLER (AIRCRAFT) TITLE 32 PERMANENT
Air National Guard Units
Newington, NH
- $69,905 to $90,882 USD / year
…Monitors progress of job completion by dispatched personnel. Controls maintenance on assigned aircraft and related support and training equipment. Takes prompt and decisive action to make…
Added 25 mins ago
TT
Market Data Engineer
Trading Technologies
New York, NY
- $175,000 to $200,000 USD / year
We are looking for an experienced Market Data Engineer with at least 8 to 10+ years of relevant professional experience in software engineering and financial market data systems. Must have…
Added 25 mins ago
AN
Aircraft Mechanic (Title 32) (Indefinite)
Army National Guard Units
Sandston, VA
- $35 to $41 USD / hour
Clears Red X status symbols on aircraft forms for work performed by others. Performs in-process and final inspection of others' work on assigned aircraft and components and certifies by…
Added 26 mins ago
IG
Network Security Engineer/Architect
Insight Global
Remote, United States
- From $75 USD / hour
…Palo Alto, Cisco ASA and FTD (working alongside the wireless engineer on this role). Can find and close gaps in architecture, monitoring, process and…
Added 27 mins ago
AN
TITLE 32 AIRCRAFT MECHANIC (MI AASF 1)
Army National Guard Units
Grand Ledge, MI
- $38 to $44 USD / hour
…required to perform duties per the military definition of Flight…
Added 34 mins ago
Lead CNC Programmer - Broach/Repair
GE Vernova
Greenville, SC
Provide CNC related support to M.E. (Manufacturing Engineer) and provide operator training during new / rebuilt machine startup and / or process improvements
Added 34 mins ago
C4I Systems Engineer
BOOZ, ALLEN & HAMILTON, INC.
North Charleston, SC
As a systems engineer on our team, you have the chance to shape Naval C4I Sustainment and Modernizations Efforts by leading the best C4I engineering teams in the business. Your customer…
Added 34 mins ago
Staff Software Engineer, Platform
Jobgether
Remote, United States
…and next steps. Our partner is looking for a Staff Software Engineer, Platform based in the United…
Added 37 mins ago
AN
GENERAL ENGINEER (Title 5)
Air National Guard Units
Des Moines, IA
- $90,234 to $117,307 USD / year
As a GENERAL ENGINEER (Title 5), GS-0801-12, you will perform the following duties.
Added 42 mins ago
VH
Biomedical Engineer
Veterans Health Administration
Tulsa, OK
- $71,125 to $139,166 USD / year
The Eastern Oklahoma VA Health Care System seeks a Biomedical Engineer to support healthcare technology management. Responsibilities include assessing, acquiring, implementing, maintaining,…
Added 42 mins ago
VH
Biomedical Engineer
Veterans Health Administration
Tulsa, OK
- $71,125 to $139,166 USD / year
The Eastern Oklahoma VA Health Care System seeks a Biomedical Engineer to support healthcare technology management. Responsibilities include assessing, acquiring, implementing, maintaining,…
Added 44 mins ago
Civil/Structural Engineer
Leidos
Denver, CO
…substations and transmission and distribution lines; protection and controls design; and electrification programs. Utilities consistently come to Leidos for reliable power expertise, as…
Added 44 mins ago
K
Lead Mechanical Engineer
Kiewit
Lone Tree, CO
- $100,000 USD / year
We are hiring a Lead Mechanical Engineer to support our Industrial team. This position is critical to delivering safe, efficient, and resilient EPC and Design build projects across our…
Added 44 mins ago
Electrical Engineer - Contract and Direct
Kiewit
Lone Tree, CO
Our rapidly growing Industrial Design Group, which includes process, electrical, controls, structural, architectural, geotechnical, and civil disciplines, is a multi-faceted and…
Added 44 mins ago
Software Engineer – Level 2 or Level 3
Northrop Grumman
Aurora, CO
Northrop Grumman’s Space Sector is seeking a Software Engineer – Level 2 or Level 3 to join our team in Aurora, CO. This position is 100% onsite and cannot accommodate telecommute work.
Added 45 mins ago
Associate Software Engineer - Colorado Springs
Northrop Grumman
Colorado Springs, CO
The qualified candidate will become part of Northrop Grumman’s Software and Controls Engineering team.
Added 1 hour ago
CO
Electrical Engineer I or II
City of Ames
Ames, IA
- $37.07 to $54.2 USD / hour
The Electric Services department within the City of Ames has an exciting opportunity for an Electrical Engineer I or II!
Added 1 hour ago
US
FACILITY OPERATIONS SPECIALIST
United States Space Force
Cheyenne Mountain AFB, CO
- $41,811 to $99,650 USD / year
…and construction of all assigned facilities of the 21 Civil Engineer…

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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