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 (e.g., 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 GAMP5 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 (-80 C.)
• Standard Freezers (-20 C.)
• Refrigerators.
• CO2 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.

• 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 (e.g., 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