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Validation engineering specialist

Carlow
Ellab
Engineering
Posted: 20h ago
Offer description

Exciting opportunity for you to join Carlow’s high‑performing manufacturing site to deliver safe, reliable medicines at global scale. We’re hiring a Validation Engineer to lead compliant, data‑driven qualification and validation across critical systems.What you will do:Planning, scheduling and oversight of Periodic Revalidation & Initial Qualification studies.Responsible for setting and delivery of validation strategies.Lead and supports complex & critical investigations associated with validation and commercial activities.Co-ordinate multiple complex projects in parallel including but not limited New Product Introductions, Process Improvements and Investigations.Execution of Periodic Revalidation, Cycle Development & Initial Qualification studies as required.Technical review and approval of Periodic Revalidation, Cycle Development & Initial Qualification protocols & reports.Authoring and reviewing standard operating procedures and technical reports.Engage in the early stages of projects.Act as validation SME on the equipment within the area assignedWhat skills you will need:In order to excel in this role, you will more than likely have:Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.A minimum of 2-3 years directly related experience in pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.SME in Cleaning Validation for reusable parts and process vessel washing and using Automated COP and CIP systemsKnowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.If you are interested in hearing more please contact Cara Keegan on cmua@ellab.com or send your CV into hr-irl@ellab.com.
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