Quality Control Engineer

Description

• Plan, execute, and document temperature mapping studies for chambers (cold rooms, freezers, incubators, stability chambers).
  
  
• Prepare and review validation protocols, reports, and deliverables in Kneat or equivalent systems.
  
  
• Perform data integrity assessments and ensure compliance with GDP and ALCOA+ principles.
  
  
• Draft and maintain SOPs for temperature mapping and chamber qualification.
  
  
• Support deviation management, change control, and CAPA implementation.
  
  
• Provide technical input for requalification planning and continuous improvement.
  
  
• Collaborate with QC, QA, and Engineering to support audit and inspection readiness.
  
  

Responsibilities

• Good experience in temperature mapping of chambers within pharmaceutical/biotech or regulated industries.
  
  
• Knowledge of GDP, ALCOA+ principles, and qualification practices.
  
  
• Familiarity with mapping across a variety of chambers is advantageous.
  
  
• Experience with validation documentation and use of Kneat preferred.
  
  
• Strong technical writing, data review, and teamwork skills.