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Scarborough, Maine

•

Today

Description We are seeking a highly motivated and detail-oriented Validation/Quality Engineer to support our manufacturing operations. This role is critical in ensuring compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards. The ideal candidate will lead validation activities, maintain robust quality systems, and drive continuous improvement initiatives across manufacturing processes. Key Responsibilities: Validation & Qualification: Develop and execute validation protocols (I

Full-time

USD 60.00 - 65.00 per hour

RTL Validation Engineer

Remote

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28d ago

Position: RTL Validation Engineer Location: Dallas, TX ( Remote) Duration: 6 months Visa Preference: GC s, EAD s, L2 EAD s RTL Validation, working knowledge of PCIE/CXL protocols. Familiarity with simulation technologies.Exceptional analytical skills and problem solving skills.Experience in crafting testbenches, methodologies for large and complex chips.Deep understanding of verification concepts.Proficiency with at least one of these - C++, Object Oriented Programming, UVM, System Verilog.Fam

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Contract, Third Party

Depends on Experience

Computer System Validation Engineer

Remote or New Jersey

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Today

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

Full-time

Engineer III, Validation

Remote or Fair Lawn, New Jersey

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Today

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

Full-time

Engineer III, Validation

Remote or Waltham, Massachusetts

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn

Full-time

Engineer II, Validation

Remote or St. Louis, Missouri

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you

Full-time

Computer System Validation Analyst - R Studio & Clinical Systems

Remote or New Jersey

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Today

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

Full-time

Validation Lead, SAP S4 HANA

Remote or New Jersey

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Today

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

Full-time

Sr. Analyst, IT Validation Services

Remote or Hybrid in Stamford, Connecticut

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Today

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

Easy Apply

Contract

BASED ON EXPERIENCE

Mid-level, FIPS 140 Security Engineer & CVP Certified Tester

Remote

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Today

Mid-level, FIPS 140 Security Engineer & CVP Certified Tester Work model: REMOTE Department: FIPS/Testing Location:Columbia, MD Role Type:Contract No Clearance Required* Not available on C2C contract basis* About Our Client Our client offers an exciting opportunity to work in the rapidly expanding IT Security field, integral to supporting national defense initiatives. This organization plays a crucial role in ensuring national security by evaluating and validating IT security products that are

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Contract

Depends on Experience

Senior, FIPS 140 Security Engineer & CVP Certified Tester

Remote

•

Today

Senior, FIPS 140 Security Engineer & CVP Certified Tester Work model: REMOTE Department: FIPS/Testing Location: Columbia, MD Role Type: Contract No Clearance Required* Not available on C2C basis* About Our Client Our client offers an exciting opportunity to work in the rapidly expanding IT Security field, integral to supporting national defense initiatives. This organization plays a crucial role in ensuring national security by evaluating and validating IT security products that are deployed t

Easy Apply

Contract

Depends on Experience

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

Remote or Hybrid

•

Today

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

Full-time

USD 186,200.00 - 285,300.00 per year

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