21113481-Validation Engineer II-Athlone Contractor

This is a 12-month initial contract.

Responsibilities

• Duties: Lead Development and execution of CD and PQ requirements for new projects.
• develop and execute Requal protocols for various Thermal Systems (Autoclave, SIP, CTUs)
• Lead investigations on validation deviations where required.
• Identify and Implement Continuous improvement initiatives.
• Adhere to site EHS standards and reporting requirements.

Requirements

• 3 – 6 Years of Experience

Thermal Systems Validation Engineer core competencies and qualifications:

• Direct Experience with hands-on qualification of Steam Sterilization Autoclaves and porous loads
• Understanding of the EN285 Requirements and testing
• Understanding of the Saturated Steam requirements, heat transfer, and Sterilization kill kinetics.
•  Understanding of the Cycle Development and Performance requirements for the Porous Load sterilization
•  Understanding and handling of the Biological Indicators used for Steam Sterilization
•  Understanding of the SIP (Steaming/Sterilization in Place) system design and SIP CQAs
•  Direct Experience with hands-on for SIP qualification
•  Understanding of the Filter Integrity Testing requirements for SIP applications
•  Direct Experience with hands-on qualification of Depyrigenation Tunnel
•  Understanding of the Endotoxins and thermal Requirements for Depyrogenation cycle (dry heat)
• Direct Experience with execution of Control Temperature Units and qualification requirements
•  Direct Experience using thermal acquisition systems.
•  Understanding of the Aseptic Manufacturing processes
•  Understanding of the Quality System Elements:

a. Deviation

b. CAPA

c. Calibration

d. Preventative maintenance

e. Change Control