CQV Engineers
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.
- 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.
- Controlled Temperature Units & Storage:
- Cryogenic Freezers.
- Ultra-low Freezers (-80 C.)
- Standard Freezers (-20 C.)
- Refrigerators.
- CO2 Incubators.
- General Incubators.
- Ovens.
- Stability Chambers.
- Biosafety Cabinets.
- Fume Hoods.
- Flammable Cabinets.
- Lyophilises
- Cryostats.
- AHUs (Air Handling Units.)
- Room HVAC systems (supply/exhaust units.)
- HVAC Controls and Sensors.
- Client-connected ventilation devices.
- Purified Water (PW) Distribution System.
- Clean Steam Supply.
- Clean Compressed Air.
- Nitrogen Lines for Clean Applications.
- WFI (if confirmed in detailed docs.)
- 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.)
- Environmental Monitoring System (EMS.).
- Building Management System (Client.).
- Temperature and Humidity Sensors.
- Alarming and Notification Panels.
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