Job Title: Cleaning Validation Specialist - Pharmaceuticals
A leading biopharmaceutical organisation is seeking a Cleaning Validation Specialist for a 12-month contract based in Dublin.
Responsibilities:
* Maintain/update input to the Cleaning/Validation Master Plan to support the multi-product drug substance manufacturing facility.
* Develop and implement/update cleaning strategies for fixed and mobile parts.
* Development/update and/or optimise cleaning (CIP) 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 to occur.
* 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:
* At least 2 years' experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organisation.
* Technical and operational knowledge of cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
* Experience of cleaning validation.
* Experience of cleaning verification/validation of downstream processing equipment.