The Cleaning Validation Technical Specialist will support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at the companies facility in Dublin. The Specialist will provide cleaning validation expertise to support the facility design, start-up and routine commercial manufacturing. The Cleaning Validation Technical Specialist will be 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.
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Purpose: This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company...Apply For This Job