Experience

The ideal candidate should preferably have a minimum of 6 months experience in Engineering, Maintenance, Commissioning,
Qualification and Validation in an Industrial Environment, preferably in the pharmaceutical industry.

Must have experience in preparing and executing commissioning, qualification and validation documentation, such as:

  • Impact Assessment (IA)
  • Risk Assessment (RA)
  • User Requirements Specification (URS)
  • Conducting Enhanced Design Review
  • Preparation and execution of Design Qualification
  • Preparation and execution of commissioning
  • Preparation and execution of Installation Qualification
  • Preparation and execution of Operational Qualification
  • Preparation and execution of Performance Qualification

Technical Skills

  • Degree in Engineering
  • Knowledge of GMP and FDA regulations
  • Strong organizational and communication skills
  • Fluency in English
  • Critical analysis skills and proactive personality
  • Ability to work in a multidisciplinary team