Validation Engineer

Overview

On Site
Full Time

Skills

Risk Assessment
Testing
Regulatory Compliance
GMP
Data Integrity
Change Control
Documentation
Continuous Improvement

Job Details

Job Summary:
A leading organization is seeking an experienced Validation Engineer to support validation strategy, compliance, and qualification activities for digital solutions in a GMP-regulated environment.

Roles and Responsibilities:
  • Develop and implement validation strategies aligned with regulatory and internal standards.
  • Create validation plans and protocols for digital solutions, data pipelines, models, and automation tools.
  • Perform risk assessments and define mitigation controls.
  • Execute testing, qualification, and documentation activities.
  • Ensure compliance with GMP, data integrity, and industry guidelines.
  • Maintain validation plans, protocols, reports, and change control documentation.
  • Lead continuous improvement initiatives for validation processes.
  • Act as liaison between business and IT to drive scoping and stakeholder alignment.
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