21195033-Validation Engineer-Athlone Contractor

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.

Requirements:

• 3 – 6 Years of Experience

• Direct Experience executing or oversight of the Clean Room Certification Testing against ISO 14644 CAPA

HVAC Validation Engineer core competencies and qualifications:

• Understanding of the ISO 14644 Clean Room Testing Requirements

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

• 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