CSV Engineer jobs in New Jersey

Hybrid in Raritan, New Jersey

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9d ago

Job Description: Experience in validating ERP/SAP/ MES Manufacturing applications 3+ years experience with System Development Lifecyle 7+ years experience in Computer System Validation (Based on the role selected) Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation Experience in writing and executing docum

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Depends on Experience

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

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

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

CSV Engineer

Raritan, New Jersey

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Today

Roles & Responsibilities: 5-10 years' experience in Computer System Validation of GxP systems. Must have experience in Agile methodology and handled multiple releases in parallel. Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation. 5+ years of experience in validating SAP application implementation, test script review, test execution review, test defect management. Has working experience in any one or two of the following domains Tool validation like Servic

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

CSV Engineer

New Jersey

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Today

Roles & Responsibilities: We are now looking for a resource on the validation side of things going on here. Depending on the resource, we're looking for someone with (LabVantage) LIMS and quality systems validation experience, and/or general more broad Pharma/Biotech CSV experience that could back-fill as staff augmentation. Engagement would be (at least) through the end of the year. Potential in-scope activities. i. CSV/Lab Systems Qualification document/deliverable authoring. ii. Test script/p

Full-time

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

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CSV Engineer jobs in New Jersey, USA