Validation Specialist

Responsibilities

• Execute site validation activities according to regulatory and site requirements
• Control Aseptic process validation and particle runs from protocol generation to reporting
• Support equipment process qualification and investigation of validation/PQ challenges
• Establish KPIs and own execution of routing CPV/OPV reporting
• Provide technical assessments and approvals for engineering and process changes
• Implement and evaluate raw material and consumable changes, including leachable/extractable studies
• Oversee manufacturing visual inspection, manufacturing control strategy, and microbial control strategy
• Assess change controls for validation impact and work cross-functionally to implement automation platforms

Requirements

• Bachelor’s degree in Industrial, Manufacturing, or Mechanical Engineering or a related field
• 2 years of experience in validation or manufacturing/process/production engineering within the pharmaceutical/biopharma industry
• Proficiency in process validation, equipment qualification, or aseptic processing
• Experience writing or supporting Quality Risk Assessments

About the Company

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy.