Search Jobs | Dice.com

Job Details

Skills

Computerized System Validation
Gen AI
Agentic
Validation Lead
Medical Devices

Summary

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

Location: Raritan, NJ(Hybrid)

Duration: 12 Months

Job Description:

Experience with Validation of GEN AI solutions in GxP environment is key.
Look for someone who has supported CSV AI projects

•               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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: prutx001
Position Id: 9027888
Posted 1 day ago

Fitment

Dice Job Match Score™

🔗 Matching skills to job...

Contact the job poster

Sai Sree Kuncha

Recruiter @ Prudent Technologies and Consulting

View Profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Validation Lead

Raritan, New Jersey

•

Today

We are looking for Validation Lead for our client in Raritan, NJ. Job Title: Validation Lead Job Location: Raritan, NJ Job Type: Contract Job Overview: Pay Range: $48hr - $53hr Requirement/Must Have: Experience in the Pharmaceutical, biotechnology, or medical device industry.2+ years experience with System Development Lifecycle.3+ years experience in Computer System Validation.Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validati

Easy Apply

Contract, Third Party

Depends on Experience

CSV Engineer

Raritan, New Jersey

•

Today

Job Summary: Shop Floor CSV/CSA Lead/Engineer responsible for leading and executing validation deliverables across the lifecycle in regulated manufacturing and laboratory GMP/GLP environments. The role includes automation/controls validation, risk-based validation activities, audit readiness, data integrity compliance, and coordination with IT/OT teams for validated systems. Roles & Responsibilities: Lead and execute validation deliverables including risk assessment, validation planning, require

Full-time

Validation Lead(Computer System Validation GenAI, Agentic QMS)

Remote or New Jersey

•

Today

Validation Lead(Computer System Validation GenAI, Agentic QMS) Raritan, NJ (Onsite - Hybrid) Long Term Contract Job Details: Experience in the Pharmaceutical, biotechnology, or medical device industry Experience with Validation of GEN AI solutions in GxP environment is key 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 validatio

Easy Apply

Contract

AI Validation Engineer, Macro Technology

New York, New York

•

Today

A Career with Point72's Technology Team As Point72 reimagines the future of investing, our Technology team is constantly evolving our firm's IT infrastructure and engineering capabilities, positioning us at the forefront of a rapidly evolving technology landscape. We're a team of experts who experiment and work to discover new ways to harness open-source solutions, modern cloud architectures, and sophisticated Artificial Intelligence (AI) solutions, while embracing enterprise agile methodologie

Full-time

USD 140,000.00 - 200,000.00 per year

Filter Results

Job post features

Posted date

Work settings

Employment type

Distance

Employer type

Work authorization

Computer System Validation

Skills

Summary

Dice Job Match Score™

Sai Sree Kuncha

Similar Jobs

Computer System Validation

Job Details

Skills

Summary

Dice Job Match Score™

Sai Sree Kuncha

Similar Jobs