VALIDATION TECHNICIAN
SMOKE STUDIES

The role of the "Validation Technician" with experience in performing Smoke Studies (Airflow Visualization Studies) will involve conducting Smoke Studies to verify airflow patterns and ensure the proper movement of air within controlled contamination environments or installations.

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  Responsibilities:

  
  
  
  
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    • Conduct Smoke Studies: Verify airflow patterns to ensure the proper movement of air within controlled contamination environments or installations.
    
    
    • Video Recording and Editing: Plan, execute, and edit video recordings to document and analyze airflow and other validation activities.
    
    
    • Qualification and Requalification of Pharmaceutical Systems: Perform qualification activities in compliance with current regulations and GMP (Good Manufacturing Practice Guidelines) requirements.
    
    
    • Project Management: Coordinate and oversee testing, validation, and documentation phases, ensuring adherence to quality standards and deadlines.
    
    
    • Collaboration with Various Operational Areas: Work closely with different teams to meet deadlines and ensure high-quality work while fostering a collaborative and efficient work environment.
    
    
    • Validation Documentation Preparation: Draft comprehensive reports or protocols for qualification activities, ensuring traceability and compliance with current regulations.
    
    
    • Compilation of Qualification and Requalification Reports: Compile reports and documentation by collecting data from qualification activities, including detailed documented evidence of tasks performed.
    
    
    
    
  
  
  
  

Requirements:

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    • Diploma or degree in a technical/scientific field.
    
    
    • At least one year of experience as a validation technician or in similar positions.
    
    
    • Strong knowledge of regulations and quality standards (UNI EN ISO 14644-1, UNI EN ISO 14644-3, and EudraLex - Volume 4 Annex 1).
    
    
    • Proficiency in IT.
    
    
    • Solid knowledge of videomaking.
    
    
    • Familiarity with the following software: Blackmagic DaVinci Resolve and DJI Mimo.
    
    
    • Experience with validation instrumentation – HVAC.
    
    
    • Attention to detail and precision.
    
    
    • Strong analytical and problem-solving skills.
    
    
    • Good communication skills and a team-oriented attitude.
    
    
    • Availability for frequent domestic travel.
    
    
    • Availability for international travel.
    
    
    • Good command of the English language.
    
    
    
    
  
  
  
  

We Offer:

A stimulating growth path with leading clients in the pharmaceutical sector, providing opportunities for professional development in a dynamic and innovative environment.