CQV Engineer

Overview

On Site
Full Time

Skills

FOCUS
IQ
OQ
PQ
URS
Risk Assessment
Reporting
Auditing
Mapping
GAMP
Documentation
GDP
Storage
Laboratory Equipment
HVAC
Distribution
Electrical Engineering
Lighting
Power Supply
Adobe AIR
GMP
Element Management System
EMS
Management
Sensors

Job Details

Responsibilities:
  • 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.
Requirements:
  • 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.
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.
  • Lyophilizes.
  • Cryostats.
HVAC and Air Handling:
  • HUs (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.
  • larming and Notification Panels.
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