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.