medical validation/qualification engineer Jobs in jersey city, nj

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Validation Engineer

Katalyst Healthcares and Lifesciences

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Summit, 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 equipment qualification and systems validation activities. Configures and documents the configuration of computerized systems. Develops
Posted 5 days ago | Updated 4 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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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
Posted 50 days ago | Updated 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 38 days ago | Updated 4 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 4 hours ago

Sr Process Validation Engineer

Katalyst Healthcares and Lifesciences

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Franklin Lakes, New Jersey, USA

Full-time

Responsibilities: Author and execute Master Validation Plans (MVPs), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports in compliance with regulatory and internal standards. Lead validation activities for critical manufacturing processes including: Liquid phase mixing of formulation materials. Lyophilization (freeze-drying). Moulding and sizing of bioabsorbable components. Maintain and own Process FMEA (pFMEA) documentation and risk management files in
Posted 11 days ago | Updated 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Piscataway, New Jersey, USA

Full-time

Position Overview: Looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, adhering to project timelines, ensure compliance with company and industry standards and participating in cross-functional teams. Required Skills: Experience with drafting and executing IQ / OQ / PQ. CAD proficiency to
Posted 60+ days ago | Updated 4 hours ago

Validation - Commissioning/Qualification Specialist / Specific Commissioning and Validation support

Futran Solutions

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Warren, New Jersey, USA

Full-time

Job Description: Validation Qualification Specialist This role is 100% Onsite Work Schedule: Mon - Fri, Business Hours 1. PURPOSE AND SCOPE OF POSITION: The Validation Engineer supports the successful implementation of laboratory equipment and 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 facility, utility, and equipment qualification. With minimum sup
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Posted 60+ days ago | Updated 9 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 6 days ago | Updated 4 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 4 hours ago

Network Validation Engineer

Kramers Consulting

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Remote

Contract, Third Party

Job Title: Network Validation Engineer Location: Remote from anywhere in the USA Duration: 12 months to start with possibility to renew Job Description Debug and automate deployment problems typically found in aggregate systems built from multiple vendors like, HPE, Dell, Cisco, NetApp, Palo Alto, Thales etc.Hardware validation of the GDC Systems.Working closely with System Integrators and our partner teams to build, troubleshoot and mitigate issues using tools to reduce resolution time.Understa
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Posted 1 day ago | Updated 13 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

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
Posted 16 days ago | Updated 4 hours ago

Engineer II, Validation

Thermo Fisher Scientific

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Remote or St. Louis, Missouri, USA

Full-time

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
Posted 22 days ago | Updated 4 hours ago

Sr. Analyst, IT Validation Services

Russell, Tobin & Associates

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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
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Posted 42 days ago | Updated moments ago

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 4 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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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
Posted 60+ days ago | Updated 4 hours ago

Model Validation Associate Director

DTCC

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Jersey City, New Jersey, USA

Full-time

Are you ready to make an impact at DTCC? Do you want to work on innovative projects, collaborate with a dynamic and supportive team, and receive investment in your professional development? At DTCC, we are at the forefront of innovation in the financial markets. We are committed to helping our employees grow and succeed. We believe that you have the skills and drive to make a real impact. We foster a thriving internal community and are committed to creating a workplace that looks like the world
Posted 60+ days ago | Updated 1 hour ago

Model Validation Director- Market Risk/Liquidity Risk/Quantitative Research

The Caldwell Group

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Jersey City, New Jersey, USA

Full-time

Master s or Ph.D. in Quantitative Finance, Mathematics, Economics, Financial Engineering, or other quantitative fields.3-5 years of experience in financial risk model validation, risk analytics, or quantitative modeling.Strong expertise in valuation models (curve building, term structure models, option pricing, credit models).Experience with risk management models (Greeks, VaR, back testing, stress testing).Deep understanding of model risk management frameworks, particularly SR 11-7 guidelines.K
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Posted 60+ days ago | Updated 2 days ago

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

General Motors

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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
Posted 34 days ago | Updated 1 hour ago

Model Validation - Advisor

Fannie Mae

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Remote or Washington, District of Columbia, USA

Full-time

At Fannie Mae, the inspiring work we do helps make a home a possibility for millions of homeowners and renters. Every day offers compelling opportunities to impact the future of the housing industry while being part of a collaborative team thriving in an energizing environment. Here, you will grow your career and help create access toaffordable housing finance. Job Description THE IMPACT YOU WILL MAKE The Model Validation - Advisor role will offer you the flexibility to make each day your own