- Develop and Execute Qualification and Requalification
protocols for Site HVAC systems.
- Lead investigations for HVAC validation issues and
- Provide Validation SME Support for associated HVAC
equipment Upgrades and Change projects.
- Onsite Management of Contractors for HVAC qualification
- 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.
of the ISO 14644 Clean Room Testing Requirements
Experience executing or oversight of the Clean Room Certification Testing
against ISO 14644
of the EU GMP Grade (A/B/C/D) requirements and qualification scope
of the RABS Filling Line and HVAC Requirements
of the Isolator Filling Line and HVAC Requirements
of the Unidirectional Air Flow requirements and qualification
of the Aseptic Manufacturing processes and contamination control
of the AHU Control and monitoring systems.
9. Good trouble shooting and problem solving skills on HVAC
of the Quality System Elements:
3 – 6 Years of Experience