CQV Engineer

Summary:
Our client is a biopharmaceutical company based in Athlone looking for a CQV Engineer to develop and execute Qualification and Requalification protocols for Site HVAC systems.

Responsibilities:

• 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.

Qualifications & Experience:

• Minimum Degree in relevant discipline.
• 3 – 6 years’ experience in a similar role in a GMP regulated environment.
• Direct Experience executing or oversight of the Clean Room Certification Testing against ISO 14644.
• Understanding of the ISO 14644 Clean Room Testing Requirements.
• Understanding of the EU GMP Grade (A/B/C/D) requirements and qualification scope.
• Understanding of the RABS Filling Line and HVAC Requirements.
• Understanding of the Isolator Filling Line and HVAC Requirements.
• Understanding of the Unidirectional Air Flow requirements and qualification.
• Understanding of the Aseptic Manufacturing processes and contamination control.
• Understanding of the AHU Control and monitoring systems.
• Good trouble shooting and problem solving skills on HVAC systems essential.
• Understanding of the Quality System Elements, Deviation, CAPA, Calibration, Preventative maintenance, Change Control.