Summary: Our client is a biopharmaceutical company in Waterford looking for a Process Engineer who will supportmanufacturing and drive development and implementation of improvement initiatives in the fill finish manufacturing and development operations. Responsibilities: Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations Optimisation of manufacturing and development operations Identification & implementation of opportunities for improvements Assist in the implementation of capital projects Act as process lead for inspection development Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams. Implementation and monitoring of performance metrics. Lead cycle time reduction initiatives in conjunction with manufacturing teams Implementation of best practice Process development programme design / plant trials, execution and implementation Constantly seeking to challenge operational standards and driving continuous improvement. Maintain required quality documents in a current compliant state. Resource for Clinical supply provision projects Aseptic manufacture or oral dose manufacture context Design and execution of experimental programmes Operation of process laboratories Scale-up and technology transfer project role Liaison for Clinical supply provision projects Liaison for new formulation and product enhancement programmes Technical representative for assessment and development of process change control and regulatory submission proposals Technical support and trouble-shooting in support of manufacturing activities Support of process qualification and process validation activities as required Qualifications & Experience: Degree in Chemical, Industrial or equivalent Engineering discipline Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage 2 years + experience within Pharmaceutical Development and Manufacturing environment OEE/SMED/RCA/CI experience.Technical knowledge of aseptic manufacturing including lyophilisation considered an advantage Pharmaceutical product development project life-cycle Structured Problem-solving skills Statistical