Expert Equipment Validator

3 days ago

Singapore beBeevalidation Full time $90,000 - $120,000
Validation Specialist

We are seeking a highly skilled Validation Specialist to join our team. This role will involve the execution of various qualification and validation activities across critical equipment and controlled environments.

The ideal candidate will have experience in temperature mapping, environmental validation, and equipment qualification using Kaye AVS.

  • Temperature Mapping & Environmental Qualification:

This includes conducting thermal mapping studies for Cold Rooms (2°C to 8°C), Freezers, and Incubators using Kaye AVS, as well as preparing and executing IOPQ protocols, performing data analysis, and compiling comprehensive validation summary reports.

  • Manage requalification of site autoclaves and qualification of new units, ensuring alignment with cGMP standards.
  • Support introduction of new loads such as towel packs and perform specialized tests like the Air Detector Test.
  • Develop and execute SOPs, OPQ protocols, and performance verification plans for all validated loads.
  • Validate and qualify Kaye Validator AVS systems through IOQ protocol development, execution, and reporting.
  • Support calibration and maintenance of validation instrumentation and document performance accordingly.
  • Perform smoke studies (air visualization) for biosafety cabinets (BSCs), cleanroom zones, and equipment doors in compliance with cleanroom standards.
  • Execute protocols and prepare clear and accurate documentation including study reports.

Requirements:

  • Bachelor's Degree or Diploma in Engineering, Life Sciences, or a related technical discipline.
  • Solid experience in equipment qualification, environmental validation, and temperature mapping using Kaye AVS.
  • Knowledge of regulatory standards including cGMP, GDP, and GxP.
  • Strong understanding of validation lifecycle: IQ, OQ, PQ, and requalification.
  • Excellent technical writing, data analysis, and problem-solving skills.
  • Ability to work independently and collaboratively across functional teams.

Preferred Qualifications:

  • Previous experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
  • Familiarity with cleanroom validation and environmental monitoring standards.

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