Validation Lead

TechDigital Group; Raritan (NJ); On-site; USD 110,000 - 165,000; Full time

Job summary

TechDigital Group in the United States is seeking a Validation Specialist with experience validating GEN AI solutions in GxP environments. The role focuses on supporting CSV AI projects and ensuring compliance with FDA and global regulations.

You will write and execute documentation for validation deliverables, lead a team including remote members, and collaborate with global project teams during planning to define strategy and risk-based approaches.

Qualifications

• Experience in Pharmaceutical/biotech/medical device industries.
• 2+ years' experience with System Development Lifecyle.
• 3+ years' experience in Computer System Validation in FDA/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 (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

Skills

GxP validation experience

Strong communication

Team leadership

Gen AI validation

FDA/GAMP knowledge

Documentation writing

Remote collaboration

Job description

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