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)
• Cell and Gene Therapy Experience

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:
9. Biosafety Cabinets
10. Fume Hoods
11. Flammable Cabinets
12. Lyophilizers
13. Cryostats
    HVAC and Air Handling:
14. AHUs (Air Handling Units)
15. Room HVAC systems (supply/exhaust units)
16. HVAC Controls and Sensors
17. Client-connected ventilation devices
    Clean Utilities:
18. Purified Water (PW) Distribution System
19. Clean Steam Supply
20. Clean Compressed Air
21. Nitrogen Lines for Clean Applications
22. WFI (if confirmed in detailed docs)
    Black Utilities:
23. Electrical Panels and Subpanels
24. General Lighting and Emergency Power
25. Power Supply to Equipment
26. Grounding Systems
27. Compressed Air for Technical Use
28. Cooling/Heating loops (non-GMP)
    Monitoring and Control Systems:
29. Environmental Monitoring System (EMS)
30. Building Management System (Client)
31. Temperature and Humidity Sensors
32. Alarming and Notification Panels
    Job Type: Contract
    Pay: $55.91 - $99.55 per hour

Benefits:

• Relocation assistance

Work Location: Remot

Please refer the Job description for details