Job Description

Duties:

• Develop and Execute Qualification and Requalification
  protocols for Site HVAC systems.
  
• Lead investigations for HVAC validation issues and
  Deviations.
  
• Provide Validation SME Support for associated HVAC
  equipment Upgrades and Change projects.
  
• Onsite Management of Contractors for HVAC qualification
  support.
  
• Identify and Drive Continuous Improvement initiatives for
  HVAC validation activities and HVAC systems. 
  
• Adhere to site EHS standards for day to day activities
  and incident reporting.
  

Requirements

   1. Understanding
of the ISO 14644 Clean Room Testing Requirements

   2. Direct
Experience executing or oversight of the Clean Room Certification Testing
against ISO 14644

   3. Understanding
of the EU GMP Grade (A/B/C/D) requirements and qualification scope

   4. Understanding
of the RABS Filling Line and HVAC Requirements

   5. Understanding
of the Isolator Filling Line and HVAC Requirements

   6. Understanding
of the Unidirectional Air Flow requirements and qualification

   7. Understanding
of the Aseptic Manufacturing processes and contamination control

   8. Understanding
of the AHU Control and monitoring systems.

   9. Good trouble shooting and problem solving skills on HVAC
systems essential.    

         a.
Deviation

         b. CAPA

         c.
Calibration

         d.
Preventative maintenance

         e. Change
Control

3 – 6 Years of Experience