Validation Lead Jobs in New Jersey

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Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati

Technical Lead - Validation, Tools, and Acceleration (VTA)

General Motors

Remote

Full-time

Job Description Remote: This role is based remotely but if you live within a 50-mile radius of [Atlanta, Austin, Detroit, Warren, Milford or Mountain View ], you are expected to report to that location three times a week, at minimum. Role Overview: As a Technical Lead within the Validation, Tools, Acceleration (VTA) team under the Simulation, Evaluation, and Data organization, you will be a senior individual contributor building and optimizing the infrastructure and required technology for all

CSV Engineer

Katalyst Healthcares and Lifesciences

New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

New Brunswick, New Jersey, USA

Full-time

Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in establishing standard quality and validation pract

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in

Validation Engineer

Onkos Surgical

Parsippany-Troy Hills, New Jersey, USA

Full-time

Job DescriptionJob Summary The Validation Engineer is directly responsible for constructing and executing validation plans for equipment, processes and quality control. This role will include validation requirements, statistical analysis and testing protocols to ensure completed validations meet external Regulatory requirements and internal quality parameters. Additionally, this position will work closely and collaboratively with supporting functions including Development, Manufacturing and Qual

Sr. Analyst, IT Validation Services

Russell, Tobin & Associates

Remote or Stamford, Connecticut, USA

Contract

Job Title: Sr. Analyst, IT Validation Services Location: Remote Duration: 12 Months Pay Range: $30/hr-$35/hr on W2 (DOE) Primary Responsibilities Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls: Validation Plans/Summary Reports Risk Assessments User Requirements Specifications Test Plans Test Scripts: IQ, OQ or PQ Assess and implement the most effective validation strategy for each activity. Oversee test execution for c

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

Engineer III, Validation

Thermo Fisher Scientific

Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Validation Engineer

Katalyst Healthcares and Lifesciences

Warren, New Jersey, USA

Full-time

Responsibilities: Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. Develops protocols, and associated reports while adhering to a change management process. Supports the execution of equipment qualifications and validation protocols. Supervises vendors for qualification functions. Supports calibration, equipment qualification and validation activities. Configures and documents the configuration of computerized systems. Dev

Director of Data Engineering

Eventus WholeHealth

Remote

Full-time

Position Summary: The Director of Data Engineering will spearhead the end-to-end design, development, and optimization of a new healthcare data infrastructure, ensuring seamless operations, advanced analytics, and robust reporting solutions in a dynamic, high-growth environment. Qualifications: Education, Licensure and Certifications, Related Work Experience Degree in computer science, engineering, or related field.8+ years of experience in data engineering, with at least 3 years in a leaders

Validation Engineer

Katalyst Healthcares and Lifesciences

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses basic

Systems Engineer II - MBSE

Sierra Nevada Corporation

Remote or Lone Tree, Colorado, USA

Full-time

The ISR (Intelligence, Surveillance & Reconnaissance), Aviation, and Security (IAS) business area is a leader in ISR and aviation, it is a leading prime manned and unmanned aircraft systems integrator for innovative, high-performance ISR and aviation systems. Its end-to-end Command, Control, Computers, Communications and Intelligence, Surveillance & Reconnaissance (C4ISR) capabilities encompass design, integration, test, certification, ground/flight training and complete logistics support. IAS t

Systems Engineer III - MBSE

Sierra Nevada Corporation

Remote or Lone Tree, Colorado, USA

Full-time

The ISR (Intelligence, Surveillance & Reconnaissance), Aviation, and Security (IAS) business area is a leader in ISR and aviation, it is a leading prime manned and unmanned aircraft systems integrator for innovative, high-performance ISR and aviation systems. Its end-to-end Command, Control, Computers, Communications and Intelligence, Surveillance & Reconnaissance (C4ISR) capabilities encompass design, integration, test, certification, ground/flight training and complete logistics support. IAS t

Sr Systems Engineer - MBSE

Sierra Nevada Corporation

Remote or Lone Tree, Colorado, USA

Full-time

The ISR (Intelligence, Surveillance & Reconnaissance), Aviation, and Security (IAS) business area is a leader in ISR and aviation, it is a leading prime manned and unmanned aircraft systems integrator for innovative, high-performance ISR and aviation systems. Its end-to-end Command, Control, Computers, Communications and Intelligence, Surveillance & Reconnaissance (C4ISR) capabilities encompass design, integration, test, certification, ground/flight training and complete logistics support. IAS t

Mid/Senior Cyber Systems & Acquisition Analyst

SimVentions, Inc

Remote or Washington, USA

Full-time

Overview SimVentions is seeking a Cyber Systems Analyst/Engineer to support the SPEIR and LEED programs within PEO IWS 2.0 Above Water Sensors. This role provides direct support to APMs, Lead System Engineers, and Task Leads. A hybrid work environment is available, but on-site work in the DC area is required 2-3 times per week, with occasional travel (up to 10%). Travel Travel to Washington D.C. area 2-3 times per week and additional travel up to 10% of the time (1-2 times/month). Clearance

UKG Pro WFM Timekeeping and Integration Specialist

Sansar Tec

Remote

Contract

Job Title: UKG Pro WFM Timekeeping and Integration Specialist Department: IS Digital Health Location: Fully Remote (Philadelphia, PA-based project)Job Type:Start Date: June 30, 2025 End Date: December 31, 2025 Weekly Hours: 40 hrs/week Possibility of Extension/Conversion to Perm: YesAbout the Role:Seeking 2 highly skilled UKG Pro WFM Timekeeping and Integration Specialists to support a large-scale Workforce Management (WFM) implementation. This role focuses on timekeeping configuration, function

Sr Systems Engineer (Hybrid Eligible)

Sierra Nevada Corporation

Remote or Lone Tree, Colorado, USA

Full-time

The ISR (Intelligence, Surveillance & Reconnaissance), Aviation, and Security (IAS) business area is a leader in ISR and aviation, it is a leading prime manned and unmanned aircraft systems integrator for innovative, high-performance ISR and aviation systems. Its end-to-end Command, Control, Computers, Communications and Intelligence, Surveillance & Reconnaissance (C4ISR) capabilities encompass design, integration, test, certification, ground/flight training and complete logistics support. IAS t

Systems Engineer III (Hybrid Eligible)

Sierra Nevada Corporation

Remote or Lone Tree, Colorado, USA

Full-time

The ISR (Intelligence, Surveillance & Reconnaissance), Aviation, and Security (IAS) business area is a leader in ISR and aviation, it is a leading prime manned and unmanned aircraft systems integrator for innovative, high-performance ISR and aviation systems. Its end-to-end Command, Control, Computers, Communications and Intelligence, Surveillance & Reconnaissance (C4ISR) capabilities encompass design, integration, test, certification, ground/flight training and complete logistics support. IAS t