Validation Engineer

ref. 01274

Validation Engineer

Asset Recruitment is recruiting a Validation Engineer for a contract role, on behalf of our client, a growing pharmaceutical manufacturer in Carlow.

The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the following areas:
• Sterilisation - Autoclaves, SIP of vessels
• Cleaning - Parts Washer and CIP of vessels
• Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Dehydrogenation systems
• Controlled Temperature Units (CTU) - Temperature/Humidity Mapping
• Filter Validation
• Container Closure Integrity Validation

Primary Responsibilities for this role include, but are not limited to, the following:

• Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
• Design/Author/Review/Approve/Execute Execution/development of change controls.
• Resolving technical issues encountered during study execution.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
• Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.

Requirements:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
• Experience in sterile Fill-Finish processes and equipment.
• Knowledge of CTU equipment qualification
• Knowledge of thermal mapping equipment
• Thermal mapping skills