Validation Engineer

Description:

PE Global is currently recruiting for a HVAC Validation Engineer on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12-month contract role.

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.

Education and Experience:

• Minimum bachelor’s degree in a relevant discipline with 3-6 years experience
• 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
• Understanding of the AHU Control and monitoring systems.
• Good trouble shooting and problem-solving skills on HVAC systems essential. 9. Understanding of the Quality System Elements:
• Deviation
• CAPA
• Calibration
• Preventative maintenance
• Change Control

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***