CSV Consultant

Katalyst Talent Agency

Raritan, NJ, United States

1 day ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience required

1 year minimum

Compensation

$124,800.0

Working hours

Regular working hours

Job source

Systems Development Life Cycle SAP FI/CO System Testing SAP S/4HANA GXP

CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
The role involves working within the System Development Lifecycle (SDLC) and contributing to validation documentation and testing processes.
Strong verbal and written communication skills, Job Title: Business Information Security consultant Job Location: Raritan, NJ 08869 (open for remote) Job Duration: 6+ months Minimum years of experience required: Type of …
20 hours ago
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Experience in the pharmaceutical, biotechnology, or medical device industry
2+ years of experience with System Development Lifecycle (SDLC)
3+ years of experience in Computer System Validation (CSV)
Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation
Knowledge of FDA guidance and industry standards (e.g., GAMP)
Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously
Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports)
Experience in reviewing system test and user acceptance test (UAT) scripts, Traceability Matrix, and Design Specifications
Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT scripts, and test procedures