Sr. Qa Validation Specialist, Csv & Equipment

Legend Biotech

Raritan, NJ, United States
On-site
Computer systems validation
Equipment qualification
Process validation
Legend Biotech is seeking a Sr. QA Validation Specialist in Raritan, NJ, to oversee quality assurance processes related to computer systems and equipment validation in a cell therapy manufacturing environment. The ideal candidate will have extensive experience in quality assurance, particularly in aseptic manufacturing and compliance with cGMP regulations

Job Summary

  • Provide quality oversight over validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant.
  • Review and approve qualification/validation documentation including specifications, protocols, reports, and risk assessments.
  • Provide expertise and guidance on industry best practices and quality requirements for maintaining a compliant state for all site systems.

Matching Summary

Match Score: 85

Legend Biotech is seeking a Sr. QA Validation Specialist in Raritan, NJ, to oversee quality assurance processes related to computer systems and equipment validation in a cell therapy manufacturing environment. The ideal candidate will have extensive experience in quality assurance, particularly in aseptic manufacturing and compliance with cGMP regulations.

Skills & Requirements

Must-have

  • computer systems validation
  • equipment qualification
  • process validation
  • data integrity
  • cGMP regulations

Nice-to-have

  • cell therapy manufacturing
  • aseptic manufacturing facility
  • industry best practices
  • continuous improvement

Key Requirements

  • Bachelor’s Degree in Science or equivalent technical discipline
  • 7+ years relevant work experience
  • Experience in aseptic manufacturing facility
  • Knowledge of cGMP regulations and FDA/EU guidance
  • Experience in cGMP regulatory body audits

Work Rights

Not specified

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