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Validation Engineer

Job in South Plainfield, Middlesex County, New Jersey, 07080, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2025-12-15
Job specializations:
  • Engineering
    Validation Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below

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.

Seniority level: Mid‑Senior level

Employment type: Contract

Industry: Pharmaceutical Manufacturing

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