Equipment Qualification Specialist

17 hours ago


Kuwait City, Al Asimah Mezzan Full time

About the Role

We are seeking a skilled Equipment Qualification Specialist - Quality Assurance to join our team at Mezzan. This role is responsible for ensuring that equipment and instruments are qualified and validated to meet quality and regulatory requirements.

Key Responsibilities

  • Execution of SAT, installation, operational, and performance qualification activities for equipment and instruments.
  • Qualification of thermal validation activities, including steam sterilizers, vessels/tank systems, lyophilizers, and tunnels.
  • Equipment qualification, including filling and sealing machines, vial washing machines, external vial washing machines, HVAC systems, isolators, VHP processes, LAFs, and dynamic pass boxes.
  • Temperature mapping activities for areas and equipment.
  • Compilation of documents during and after execution of qualification/validation activities.
  • Co-ordination and planning of qualification/validation activities.
  • Compliance with validation schedules and plans to ensure timely completion of equipment qualification.
  • Preparation and review of validation master plans, site master files, qualification/validation protocols, and reports.
  • Development of SOPs related to QA validation policies and activities.
  • Review of media fill interventions trend data and participation in simulation activities.
  • Investigation of failures/discrepancies related to qualification/validation activities.
  • Review of relevant documentation, including logs, calibration records, and preventive maintenance records.
  • Engineering assurance at the site.
  • Review of CSV documents for computer system validation with compliance to current regulatory requirements.
  • Update and review of periodic qualification planners/schedules.
  • Initiation and completion of QMS documents.
  • Completion of SOP training and CGMP training.
  • Maintenance of Good Manufacturing Practices (GMP) and ISO standards, as well as good housekeeping practices.
  • Analyzing and solving engineering-related problems effectively.
  • Implementation of lean management techniques to simplify equipment qualification/validation approaches.

Requirements and Qualifications

  • Bachelor's degree in a relevant field, such as engineering or life sciences.
  • Proven experience in equipment qualification/validation, preferably in a pharmaceutical or medical device industry.
  • Strong knowledge of GMP, ISO, and regulatory requirements.
  • Excellent analytical, problem-solving, and communication skills.
  • Ability to work independently and as part of a team.


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