Validation Lead

Hybrid in Raritan, NJ, US • Posted 19 hours ago • Updated 19 hours ago
Contract W2
12 Months
No Travel Required
Hybrid
$45 - $50/hr
Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

  • Computerized System Validation
  • GAMP
  • GxP
  • Generative Artificial Intelligence (AI)
  • Validation

Summary

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

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

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: 10112463
  • Position Id: 9045151
  • Posted 19 hours ago
Contact the job poster
AJ

Amit Jha

Recruiter @ eTeam, Inc.
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