Cleaning Validation Specialist

Summary:

An exciting opportunity has arise with our client, a biopharmaceutical company in West Dublin. The Cleaning Validation Technical Specialist will support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS. The specialist will provide cleaning validation expertise to support the facility design, start-up and routine commercial manufacturing.

Responsibilities: Responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with process development, engineering, supply chain, quality, regulatory and other involved departments to ensure successful facility design, construction, startup and qualification. The position is accountable for timely completion of cleaning validation/verification related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility. 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 equipment. Development/update and/or optimize 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. Support the cleaning monitoring programme. Qualifications & Experience: Degree in Engineering or Science. Minimum of 3 years' experience working in a similar role within a GMP environment. Strong knowledge of the complete validation lifecycle. Previous experience in CIP cycles. Knowledge of both up and downstream bioprocessing.
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