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Validation Engineer

Natsoft

 

Somerset, NJ, USA

Posted On: 2 days ago
Experience: 5+ years
Availability: Hybrid
Openings: 2
Category: Validation Engineer
Tenure: No Preference/Any
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Description

You will manage validation activities and compliance requirements for enterprise applications and quality systems.

This role is on-site.

Responsibilities

  • Review and approve validation test scripts, incident reports, and validation protocols.
  • Execute risk analyses and apply a risk-based approach to prioritize validation activities against project schedules.
  • Implement GxP requirements, including GMP, GDP, GLP, and GCP, into target systems.
  • Participate in change control activities for enhancements, defect fixes, and data migrations.
  • Assist with system decommissioning, focusing on data migration and archival from legacy systems.

Required Skills

  • 5+ years of experience in validation engineering or a related role.
  • Proficiency with GxP compliance standards (GMP, GDP, GLP, GCP).
  • Hands-on experience with Jira and ServiceNow.
  • Experience writing and reviewing Test Scripts.
  • Proficiency with SharePoint and Office 365.
  • Knowledge of Regulatory Assessment, Validation Plans, and Data Migration Plans.
  • Experience with User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).

Education

Any Graduate

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