Validation Specialist
Listed on 2026-06-18
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Engineering
Validation Engineer, Quality Engineering, Pharma Engineer, Process Engineer -
Manufacturing / Production
Validation Engineer, Quality Engineering
Position Overview
Legend Biotech USA, Inc. (Raritan, NJ) seeks a Validation Specialist to execute site validation activities, address deviations, oversee pre-validation and validation activities, and control aseptic process validation and particle runs. Support equipment process qualification, validation investigations, and KPI, CPV/OPV, and APQ/APQR reporting. Provide technical assessments for engineering, process, raw material, packaging, and labeling changes. Assess validation impacts, oversee manufacturing control strategies, identify process risks, and support automation platform implementation for cell therapy development and manufacturing.
Oversee manufacturing visual inspection program.
- Bachelor's in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field.
- Minimum two years of experience as a validation or manufacturing/process/production engineer in the pharmaceutical/biopharma industry.
- Proficiency in process validation, equipment qualification, or aseptic processing.
- Experience writing or supporting Quality Risk Assessments.
$120,000 per year.
ContactEmail CV to:
Attn. E McShane, to: talent.
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