IM Regulatory Validation Lead

Ex-J&J preferred Experience in the Pharmaceutical, biotechnology, or medical device industry 2+ years experience with System Development Lifecyle 3+ 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. Knowledge of FDA guidances and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati

Technical Product Owner with pharma Domain Experience Location:Somerset, NJ (From day one onsite) Duration: 6-12 Months contract Skills Required : Product Owner , FDA , EMA, Regulatory, pharmaceutical Job Description:Act asTechnical Product Owner withglobal regulatory systems Experience in pharmaceutical regulatory frameworks (e.g., FDA, EMA) and compliance with data integrity and GxP standards. Partner with IT, quality, and compliance teams to manage change control and validation acti

Position: Senior Data Engineer Azure Orchestration & Snowflake Data Platform (GxP) Location: Somerset, NJ Duration: 6+ Months Position Summary Client is seeking a Senior Data Engineer to build and operate enterprise-grade data pipelines using Microsoft Azure as the orchestration layer and Snowflake as the enterprise data lake/warehouse. This role focuses on reliable ETL/ELT, push/pull data integration patterns, and scalable platform engineering in a GxP / validated environment. Key Responsibili