Validation Lead (Computer System Validation – GenAI, Agentic QMS)

Role - Validation Lead (Computer System Validation – GenAI, Agentic QMS)
Location - Raritan, NJ (Hybrid)
W2/C2C

Mandate: SAP, CSV, and GenAI project validating experience required

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