Validation Engineer jobs in New Jersey

Remote

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25d ago

Role: Scientific Data Management System (SDMS) Validation Engineer Location: NEAR SHORE - South America/Canada Length: Long term rolling contract CSV engineers and for the applications: Discoverant, BIOVIA ELN, SDMS, Empower, LabX, SoftMax Pro. Job Description: Job Overview: The SDMS (Scientific Data Management System) Validation Engineer is responsible for the qualification, validation, and compliance of scientific data management systems within laboratory environments, particularly in regula

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Contract

$30 - $35

Validation Engineer

New Brunswick, New Jersey

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Today

Job Description: Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Key responsibilities include developing and reviewing validation documentation (protocols, reports), performing risk and impact assessments, coordinating

Full-time

Validation Engineer

Raritan, New Jersey

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Today

Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems, combined with technical writing/documentation skills. This role is critical in ensuring compliance, validation, and accurate documentation of enterprise applications, particularly in regulated environments (GxP/21 CFR Part 11). Responsibilities: Perform Computer System Validation (CSV) activities for SAP and OpenText systems. Develop and execute validation protocols (IQ, OQ,

Full-time

Computer system validation Engineer (CSV)

Bridgewater, New Jersey

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Today

Roles & Responsibilities: Experience designing, implementing, and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management. Experience designing, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle). Experience in SAP/ERP Validation and test management. Experience leading IT risk, IT quality and IT compliance transformational programs. Experience in e

Full-time

Computer System Validation Engineer

New Jersey

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries. Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines. Experience with ERP, LIMS, MES, or other GxP systems. Extensive Experience in HPALM with Manual testing. Deep knowledge in Defect Management Life cycle. Proficient in writing validation protocols, reports, and SOPs

Full-time

Validation Engineer II

Morris Plains, New Jersey

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Today

Job Description Summary The Validation Engineer II, assists with the authoring, executing and reviewing of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Morris Plains, NJ Number of positions open: 2 Responsibilities: Supports the development of Validation/Qualification documents including drafting risk assessments, qualification protocols, deviations, and reports. Supports the execution of validation/qualification activities fo

Full-time

USD 70,000.00 - 130,000.00 per year

Process/Validation Engineer

Branchburg, New Jersey

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Today

Job Description: What are the top 3-5 skills, experience or education required for this position. Process and Cleaning Validation Experience. Equipment Qualification (IOQ/PQ). Quality System Experience (Veeva, Track wise, Compliance Wire). Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years. Statistical Analysis (Minitab or JUMP). Responsibilities: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Quali

Full-time

Analog ASIC Validation Engineer

Remote or Odon, Indiana

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Today

Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our multidisciplinary teams of engineers and scientists work in a collaborative environment that inspires the cross-fertilization of ideas

Full-time

USD 82,300.00 per year

Commercialization & Validation Engineer

Remote or Hybrid

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Today

The CSA Validation SME is a key stakeholder within the ELC CSA Center of Excellence (COE). This role ensures the integrity of CSA projects with a strong focus on risk assessment, compliance, and regulatory adherence. Acting as a subject matter expert (SME), the CSA Validation SME serves as a bridge between COE leadership, protocol authors, and testers. The SME will ensure projects meet regulatory, data integrity, and organizational (R&D/GSC/IT) policies while maintaining best practices in valida

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Contract

$70 - $75 per hour

SIP CIP Validation Engineer

South Harrison, New Jersey

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Today

Job Description: Responsible for the management and coordination of engineering activities related to CIP (Cleaning in Place) and SIP (Sterilization in Place) with external partners and internal stakeholders. Responsibilities: Review CIP/SIP design. Develop and implement CIP/SIP strategy. Review user requirements for CIP/SIP. Coordinate with external parties and internal stakeholders to ensure overall alignment and coordination of CIP/SIP design. Requirements: Minimum 5 years of experience in c

Full-time

Senior Software Verification & Validation Engineer

Remote or Cambridge, Massachusetts

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Today

Full-time

USD 82,300.00 per year

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Staff Software Systems Engineer, Behavior Validation

Remote or Hybrid

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Today

Job Description Role: As a Staff Software Systems E ngineer on the Behavior Validation team within the AV organization, you will play a critical role in leading the strategy and execution of validation efforts for autonomous vehicle software . You will leverage you r experience designing and implementing complex V&V strategies to quickly prototype, gain consensus, and move our programs forward with increased trust and efficiency. Your expertise will guide engineers in defining best practices, d

Full-time

USD 165,000.00 - 253,200.00 per year

Senior Systems Software Engineer, AV Infrastructure - Validation and Distributed Systems

Remote or Santa Clara, California

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Today

NVIDIA has become the platform upon which every new AI-powered application is built. From healthcare research applications to autonomous vehicles, or voice-recognition systems, the need for advanced perception and cognitive capabilities is exploding, and NVIDIA is right in the center of this revolution. We are seeking a motivated Senior Systems Software Engineer to join our Autonomous Vehicle Infrastructure organization, focusing on building, deploying, and operating validation platforms at scal

Full-time

USD 148,000.00 per year

Validation Engineer, Crash Safety, Vehicle Software

Remote or Palo Alto, California

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14d ago

The Crash Safety Software team is looking for an experienced software engineer to develop simulation and test infrastructure critical to releasing safety critical software with high confidence. This role will involve using core software tooling expertise to validate embedded controllers in a virtual simulation environment through Tesla's state-of-the-art Software in the Loop (SIL) infrastructure, along with testing physical ECU hardware through Hardware in the Loop (HIL) testers. You will be re

Full-time

USD 133,440.00 - 292,800.00 per year

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor 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 degree

Full-time

Validation Engineer

Summit, New Jersey

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Today

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 valida

Full-time

Lead Validation Analyst ( Gxp,Gmp)

Remote

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21d ago

Lead Validation Analyst ( Gxp/Gmp) Remote 12+Months Contract Mandatory Skills: GMP/GXP Job Summary: We are seeking an experienced Validation Lead to oversee and lead validation activities in compliance with GMP (Good Manufacturing Practice) and GxP (Good Clinical/ Laboratory Practice) regulations. The ideal candidate will have a strong background in managing validation processes for systems, equipment, and processes within regulated environments, ensuring compliance, quality, and safety standard

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Third Party, Contract

Depends on Experience

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Sr Process Validation Engineer

Franklin Lakes, New Jersey

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Today

Responsibilities: uthor 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 accord

Full-time

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Validation Engineer jobs in New Jersey, USA