CQV EngineerÂ
CQV EngineerÂ
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- The areas of focus will be on Cell Therapy and Temperature mapping.
- 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.
- Solid knowledge and proven experience with.
- 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.
- Lyophilizes.
- 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.
Employment Type
Full-time
