Job Description
This role is a 24/7 shift pattern with 33.33% shift - open to graduates with 1 + years industry experience. Purpose Responsible for providing process, technical, and validation support to operations for commercial manufacturing and Process Simulation development and execution. Accountable for all studies associated with the development of new components, products, processes systems and facilities in relation to process simulations. Co-ordination, design and execution of commercial & Process simulations studies as required. Responsibilities 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 commercial & 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 investigations 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.; Implement subsequent corrective action through the change management system. Serve as technical engineering representative for internal technical group discussions and represent technical operations at global technical forums in relation to process simulations. Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. Drive compliance of company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. Work collaboratively to drive a safe and compliant culture on site. May be required to perform other duties as assigned. Requirements Bachelors Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline. Experience in an Aseptic sterile manufacturing environment preferred. 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. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Report, standards, policy writing skills required. Equipment and process validation. Sterile filling processes and equipment. Proficiency in Microsoft Office and job-related computer applications required. Lean Six Sigma Methodology experience desired. Skills: Sterile Manufacturing Lean Six Sigma Process Validation