Validation Lead- Raritan, NJ(Hybrid)

Role - Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment with good understanding of GxP st

Role - Validation Lead Location - Raritan, NJ (Hybrid) W2/C2C Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment with good understanding of GxP

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards. Key Responsibilities: Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.Develop and execute validation documentation, including Valida

Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Demonstrated delivery experience with Generative AI and Agentic AI solutions, including validation/governance of AI-enabled systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model l