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Urgent! CQV Engineers Job Opening In Spring House – Now Hiring Katalyst HealthCares & Life Sciences



Job description


Job Description:
The scope includes thermal mapping and qualification of various GMP equipment, with a strong focus on controlled temperature units and laboratory devices.

Responsibilities:

  • Preparation and execution of Qualification Protocols and Reports.


  • Design Qualification (DQ.).


  • Installation Qualification (IQ).


  • Operational Qualification (OQ.).


  • Performance Qualification (PQ.).


  • Review and/or authoring of supporting validation documentation.


  • User Requirements Specifications (URS.).


  • Risk Assessments (, SIA.).


  • Commissioning Test Report.


  • Thermal mapping strategy definition and execution.


  • Execution of FAT/SAT, where applicable.


  • PCOM/CTP support and walkdown activities.


  • Support during regulatory inspections and internal audits.

  • Requirements:
  • Equipment qualification in GMP-regulated environments.


  • Temperature mapping and calibration.


  • Understanding of GAMP principles.


  • Good documentation practices (GDP.).


  • Capability to handle multiple systems in parallel, following a risk-based approach to prioritize tasks.


  • Experience in authoring and reviewing validation protocols and reports, including deviation management.

  • Equipment in Scope:
  • Controlled Temperature Units & Storage:

  • Cryogenic Freezers.


  • Ultra-low Freezers (-°C.)

  • Standard Freezers (-°C.)

  • Refrigerators.


  • CO Incubators.


  • General Incubators.


  • Ovens.


  • Stability Chambers.

  • Safety & Laboratory Equipment:
  • Biosafety Cabinets.


  • Fume Hoods.


  • Flammable Cabinets.


  • Lyophilises

  • Cryostats.

  • HVAC and Air Handling:
  • AHUs (Air Handling Units.)

  • Room HVAC systems (supply/exhaust units.)

  • HVAC Controls and Sensors.


  • Client-connected ventilation devices.

  • Clean Utilities:
  • Purified Water (PW) Distribution System.


  • Clean Steam Supply.


  • Clean Compressed Air.


  • Nitrogen Lines for Clean Applications.


  • WFI (if confirmed in detailed docs.)
  • Black Utilities:
  • Electrical Panels and Subpanels.


  • General Lighting and Emergency Power.


  • Power Supply to Equipment.


  • Grounding Systems.


  • Compressed Air for Technical Use.


  • Cooling/Heating loops (non-GMP.)
  • Monitoring and Control Systems:
  • Environmental Monitoring System (EMS.).


  • Building Management System (Client.).


  • Temperature and Humidity Sensors.


  • Alarming and Notification Panels.



  • Required Skill Profession

    Engineers



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      Unlock Your CQV Engineers Potential: Insight & Career Growth Guide


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