Join a life-changing pharmaceutical organisation in their mission to drive innovation.
We are recruiting for a Cleaning Validation Specialist for a 12-month contract based in Dublin.
Cleaning Validation Specialist Responsibilities:
* Maintain and update the Cleaning/Validation Master Plan to support multi-product drug substance manufacturing facilities.
* Develop and implement cleaning strategies for fixed and mobile parts.
* Develop, update, and optimise cleaning cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers, and supporting process equipment.
* Generate and execute cleaning validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities.
* Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents, and supporting documentation as required.
About you:
* You have at least 2 years of experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organisation.
* You possess technical and operational knowledge of cleaning validation/verification, quality systems, and regulatory requirements across multiple health authorities.
* You have experience in cleaning validation.
* You have experience in cleaning verification/validation of downstream processing equipment.