CSV Engineer - Katalyst Healthcares and Lifesciences - Somerset, NJ, US | Dice.com

CSV Engineer- ERP applications / SAP / MES

Hybrid in Raritan, New Jersey

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Today

Mandatory - Validation experience with ERP applications / SAP / MES 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

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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

Sr Level CSV Engineer

North Carolina

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Today

Title: Sr. Level CSV Engineer Location: NC Exp: At least 8-12yrs THIS IS A BACKFILL Client is seeking an experienced CSV Engineer to support key validation activities at a leading pharmaceutical manufacturing site. The contractor will play a critical role in ensuring compliance with regulatory and company standards by providing validation and technical support throughout the lifecycle of various systems and processes. Qualifications: Degree: Bachelor's degree in Engineering, Computer Science

Contract, Third Party

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

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