Operational Excellence Technical Specialist 11 month contract Cork AMC21774 We are currently on the lookout for an experienced Operational Excellence Technical Specialist for a global biotechnology manufacturer based in Cork. If you have 5+ years experience in a similar role and are ready for your next challenge this could be the role for you! Requirements Over 5 years experience in biopharmaceutical, pharmaceutical or medical device industry including operational excellence projects B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field. Project management experiences in wide-scaled and/or complex project. Lean six sigma qualification and experience applying these principles Strong analytical and problem-solving skills The role Support the process by wholistically reviewing the how and why individual process steps are performed, identifying areas where efficiencies can be made, and leading projects to deliver these efficiencies Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT. Be responsible for the completion of continuous improvement projects to support manufacturing operations through the development of validation schedules, master plans and validation protocols. Managing EHS and Quality investigations and overseeing batch record reviews. Provide technical support to Operation functions and changes. Apply Lean Six Sigma and Lean methodologies. Represent the department on cross-functional project teams. Adherence to highest standards for Compliance (Quality and Safety). Ensure compliance with site EHS policy, cGMP and other business regulations and lead/co-ordinate Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations. Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. If you are interested please apply today or send your CV to Skills: operational excellence GMP Lean Six Sigma