A Process Simulation Engineer is required by CareerWise Recruitment to join our Biotech clients based in Carlow an 11 month initial contract role. You will be responsible for providing process, technical, and validation support to operations for Process Simulation development and execution ROLE: * Serve as technical support for manufacturing and new product introduction. * Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support. * Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations. * Design/Author/Review/Approve/Execute process simulation qualification/validation documentation and studies in line with the standard approval process * Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis * Support continuous improvement through Lean Six Sigma methodologies. * Leading and active participation in projects, system failure investigations and investigation reports. * Execution/development of change controls to support the Process Simulation process * Contribution to Kaizen events as appropriate. * Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 whys etc. REQUIREMENTS: * 3 - 5 years operations experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution. * Demonstrated ability to coach and lead change * Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment * Bachelors Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline Please call Diarmuid Buckley today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: Process Engineer Biotech