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CSV Lead
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2025-12-05
Listing for:
TechDigital Group
Full Time
position Listed on 2025-12-05
Job specializations:
-
IT/Tech
IT QA Tester / Automation, IT Consultant
Job Description & How to Apply Below
- Validating ERP to AWS Data migration process and Data migration validation project
- Experience in the Pharmaceutical, Biotechnology, or Medical Device industry – 5+ years in System Development Lifecycle
- 5+ years' experience in Computer System Validation, based on the role
- Experience in FDA and/or globally regulated environments with good understanding of GxP standards and risk-based validation
- Knowledge of FDA guidance and industry standards (e.g., GAMP)
- Proven experience in writing and executing validation documentation such as Requirements, Validation/Compliance Plans, Test Protocols, Test Summary Reports, and Validation Reports
- Experience reviewing system test and UAT scripts, Traceability Matrices, and Design Specifications; familiar with QA methodologies, designing, reviewing, and approving Test Plans, UAT scripts, and procedures
- Strong verbal and written communication skills
- Ability to work collaboratively in teams, lead projects, or work independently
- Experience working with remote teams and managing multiple projects simultaneously
- Ability to provide validation guidance, conduct timely reviews, and escalate issues to Technology Quality Management
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