CSV-Validation/(Good Clinical Practice)

Summary: IT CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on validating ERP Master Data Governance processes and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards. Roles & Responsibilities: Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems Support validation activities fo

Role 1 : Jr.IMRegulatory Validation Lead Location:Raritan, NJ (Hybrid) Hire Type : Contract Job Description Technical Lead is responsible for end-to-end technical ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud stack 1. Work with cross functional team 2. Ensure all deliverables are met 3. Ensure Timeline is met, 2. Act as technical single point of contact for large regulatory programs 3. Understanding of Veeva (highly preferred) and AWS stack is a

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description When you are part of the team at Thermo Fisher, you'll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure

Location: Branchburg, NJ (Hybrid) Responsibilities: Serve on project technical team, consisting of cross-functional resources including but not limited to R&D, PDS&T, Quality, Biocompatibility, and Regulatory. Partner with R&D to identify user and technical product requirements for a medical device product. With Technical Lead, develop Design Verification & Validation strategy. Support Design Verification (planning, fixture development, method development, test method validation, protocol devel