Performance Engineer Full Time

3 weeks ago


Edmonton AB, Canada Tandem Project Management Ltd. Full time

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.
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.
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 RABS Filling Line and HVAC Requirements.
~ Understanding of the Isolator Filling Line and HVAC Requirements.
~ 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.

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