CQV Engineer

Only US candidates allows to apply!!

Summary:
The scope includes thermal mapping and qualification of various GMP equipment, with a strong focus on controlled temperature units and laboratory devices.

You will be responsible for:
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

About you:
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:
1. Cryogenic Freezers
2. Ultra-low Freezers (-80 C)
3. Standard Freezers (-20 C)
4. Refrigerators
5. CO2 Incubators
6. General Incubators
7. Ovens
8. Stability Chambers
Safety & Laboratory Equipment:
1. Biosafety Cabinets
2. Fume Hoods
3. Flammable Cabinets
4. Lyophilizers
5. Cryostats
HVAC and Air Handling:
1. AHUs (Air Handling Units)
2. Room HVAC systems (supply/exhaust units)
3. HVAC Controls and Sensors
4. Client-connected ventilation devices
Clean Utilities:
1. Purified Water (PW) Distribution System
2. Clean Steam Supply
3. Clean Compressed Air
4. Nitrogen Lines for Clean Applications
5. WFI (if confirmed in detailed docs)
Black Utilities:
1. Electrical Panels and Subpanels
2. General Lighting and Emergency Power
3. Power Supply to Equipment
4. Grounding Systems
5. Compressed Air for Technical Use
6. Cooling/Heating loops (non-GMP)
Monitoring and Control Systems:
1. Environmental Monitoring System (EMS)
2. Building Management System (Client)
3. Temperature and Humidity Sensors
4. Alarming and Notification Panels