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Added 1 min ago
RI
Project Engineer (Construction)
RONCELLI INC
Sterling Heights, MI
- $65,000 to $90,000 USD / year
Roncelli, Inc. is currently seeking a full time Project Engineer. The Project Engineer supports the planning, coordination, and execution of construction projects by assisting with project…
Added 15 mins ago
A
Controls Engineer
Actalent
Maple Grove, MN
- $50 to $65 USD / hour
Job Title: Controls EngineerJob DescriptionThe Controls Engineer designs and programs controls systems for complex automated machinery, taking ownership of assigned machines, machine…
Added 20 mins ago
Associate Program Director
Texas A&M Engineering
College Station, TX
The Associate Director of Professional Education Programs provides general project and program oversight for the TEES Professional & Continuing Education initiatives within Texas A&M…
Added 27 mins ago
VT
Senior Reliability Engineer
Videojet Technologies Inc.
Elk Grove Village, IL
- $120,000 to $150,000 USD / year
…health benefits, a 401(k) savings plan with employer match, and associate wellbeing programming with…
Added 33 mins ago
SL
Senior Detection Engineer
Solutions³ LLC
Arlington, VA
- $131,000 to $150,000 USD / year
Solutions³ LLC is seeking an experienced and technically proficient Senior Detection Engineer who develops, validates, deploys, and tunes detection logic supporting proactive threat hunting…
Added 33 mins ago
SL
Senior Detection Engineer
Solutions³ LLC
Arlington, VA
- $131,000 to $150,000 USD / year
Solutions³ LLC is seeking an experienced and technically proficient Senior Detection Engineer who develops, validates, deploys, and tunes detection logic supporting proactive threat hunting…
Added 35 mins ago
Business Intelligence Systems Management #12
Delan Associates, Inc
Clearwater, FL
…configuration and auditing of data warehouses to ensure quality control of…
Added 42 mins ago
CMM Programmer - Croswell Area
The Pivot Group Network
Croswell · Croswell, MI
Knowledge of statistical process control (SPC).
Added 42 mins ago
PLC Programmer - Mount Pleasant Area
The Pivot Group Network
Mount Pleasant · Mount Pleasant, MI
Troubleshoot PLC and control system issues on the production floor.
Added 42 mins ago
Software Product Management Pre Sales Senior Manager - Supply Chain
Accenture LLP Company
NY
…814,000 people with proprietary assets and platforms, deep process and industry expertise, and leading ecosystem relationships to deliver end-to-end solutions and measurable outcomes at…
Added 44 mins ago
DA
ICT Designer III
DLB Associates
Remote, United States
- $78,750 to $95,812 USD / year
…specifications and assist in the construction administration…
Added 49 mins ago
PLC Programmer - Flint Area
The Pivot Group Network
Flint · Flint, MI
Troubleshoot PLC and control system issues on the production floor.
Added 49 mins ago
Field Service Technician - Sault Ste. Marie Area
The Pivot Group Network
Sault Ste. Marie · Sault Ste. Marie, MI
Troubleshoot mechanical, electrical, and control system faults on site.
Added 49 mins ago
Field Service Technician - Shelby Township Area
The Pivot Group Network
Shelby Township · Shelby Township, MI
Troubleshoot mechanical, electrical, and control system faults on site.
Added 50 mins ago
McWane Ductile Ohio - 3rd Shift Superintendent
McWane, Inc.
Coshocton, OH
Confirm required safety checks, proper lockout/tagout release, control functions and process settings before equipment is returned to production.
Added 54 mins ago
Sr. Associate, Process Improvement Engineer
West Pharmaceutical Services
St. Petersburg, FL
In this role, you will be key to implementing new technology, developing and introducing process improvements, standards, life cycle management and validation in select process areas,…
Added 54 mins ago
Senior ServiceNow Platform Developer (1043) - Systems and Analytics - Department of Human Resources
City and County of San Francisco
San Francisco, CA
Implement HR Criteria, Role Assignment Rules, and user/group/role logic (including criteria-based role assignment) for secure and accurate access control
Added 1 hour ago
Senior Associate Software Developer, Risk Engine
SAS
Cary HQ, NC
…(2) years of experience in the job offered or as a Software Engineer or related…
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Security Technology Engineer
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Dallas, TX
Engineer, configure, test, deploy, and optimize Genetec Security Center and associated technologies, including integrations across access control, video, intrusion, analytics, and incident…
Added 1 hour ago
A
Controls Engineer
Actalent
Kansas City, MO
- $40 to $45 USD / hour
Job Title: Controls EngineerJob DescriptionThe Controls Engineer designs, programs, and commissions industrial automation control systems from concept through start-up. This role combines…
Added 1 hour ago
AC
Electrical & Controls Systems Specialist
American Crystal Sugar Co
Moorhead, MN
- $91,381.26 to $114,226.57 USD / year
The E&C Systems Specialist consults with the Maintenance Engineer, Control Systems Engineer and Electrical & Instrumentation Supervisor regarding the maintenance of control systems and…
Added 1 hour ago
Sr Associate, Mechanical Engineering
L3Harris Technologies
Huntsville, AL
L3Harris is seeking a Sr Associate Mechanical Design Engineer to support the design and development of filament‑wound composite cases for solid propulsion and controllable solids systems.…
Added 1 hour ago
DevSecOps Cloud Engineer
Trace3
Colorado Springs, CO
…their organizations to achieve competitive advantage through a process of Integrate, Automate,…
Added 1 hour ago
Readiness Coordinator - PA Work Management - New Castle Service Building
FirstEnergy
New Castle, PA
Utilize applicable critical control checklists to identify exposures ensuring safe work execution and job site safety for self and others.
Added 1 hour ago
TH
Sr./Lead Network Engineer (MUST BE CLEARED SECRET)
Tlingit Haida Tribal Business Corporation
Washington, DC
- $110,000 to $121,000 USD / year
The Senior Network Engineer delivers mission-critical network engineering, infrastructure administration, and cyber security hardening across unclassified (NIPR) and classified (SIPR)…

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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