Validation Lead(Computer System Validation – GenAI, Agentic QMS

Job Title: Validation Lead(Computer System Validation – GenAI, Agentic QMS) Location: Raritan, NJ (Hybrid - Onsite role) Duration: 6+ Months In addition to validation and regulation experience, the resource should have the following experience: Experience with Validation of GEN AI solutions in GxP environment is key. Look for someone who has supported CSV AI projects Job Details: • Experience in the Pharmaceutical, biotechnology, or medical device industry • 2+ years’ experience with System Development Lifecyle • 3+ years’ experience in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. • Knowledge of FDA guidance’s and industry standards (i.e., GAMP) • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports • Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs. • Strong verbal and written communication skills. • Ability to lead a team. Ability to work with remote teams and support several changes/projects simultaneously. • Ability to provide Validation guidance, timely reviews, and escalations to TQ management. • Ability to work with global project teams during the initial project planning phases • Ability to provide guidance on validation strategy and be able to handle the highly fluid state of the project