Description

Legend Biotech USA, Inc. (Raritan, NJ) seeks 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. Requires bachelor's in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering or a related field, plus 2 yrs of experience Validation or manufacturing/process/production engineer within the pharmaceutical/biopharma industry & proficiency in process validation, equipment qualification, or aseptic processing, & writing or supporting Quality Risk Assessments. $120,000/yr. Email CV to: Attn. E McShane, to: [email protected].