11 month contract
Validation Engineer - Isolator
On site Carlow
AMC23440

We are currently hiring for a Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support Isolator Airflow Visualisation/ VHP/HVAC Qualification.

The ideal candidate will have 3+ years of experience in validation of sterile fill finish processes and equipment and a relevant degree

In order to excel in this role, you will more than likely have:

• Experience in authoring, reviewing, executing and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents.
• Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
• 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.
• Exception / Deviation Management and Change Control.
• Demonstratable experience of leading technical related projects.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
• Equipment and process validation.
• Sterile Fill-Finish processes and equipment.

• Filter Validation
• CCI qualification
• Shipping Qualification
• Equipment Periodic Validation
• Equipment Validation Lifecycle
• Project Management Skills/Qualification
• Autoclave/SIP Sterilisation Validation
• Dry Heat Sterilisation
• Cleaning Validation
• Controlled Temperature Units/Equipment Qualification
• Vial and Syringe Processing Technologies