Cleaning Validation Specialist
We are seeking a highly skilled professional to play a pivotal role in maintaining and updating the Cleaning/Validation Master Plan for multi-product drug substance manufacturing facilities.
* Maintain and update input to the Cleaning/Validation Master Plan.
* Develop and implement effective cleaning strategies for fixed and mobile parts.
* Design, optimize, and refine cleaning cycles/methods/recipes for buffer and media preparation systems, upstream bioreactors, and downstream equipment trains.
* Design and execute cleaning validation protocols as required.
* Autor and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents, and supporting documentation.
About You:
* At least 2 years of experience in Technical Services, Manufacturing, Technical Development, or 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 in cleaning validation and verification/validation of downstream processing equipment.