PurposeThe Process Engineer is responsible for introducing new processes and/or products (product transfer). The Process Engineer will develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion.ResponsibilitiesDesign/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval processDesign/Author/Review/Approve/Execute Execution/development of change controlsContribution to Kaizen events as appropriateTechnical input into quality notification by authoring/reviewing/approving investigationsExecution of equipment/qualification validation programs; including re-qualification and re-validationSupport continuous improvement through Lean Six Sigma methodologiesPerform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issuesServe as technical engineering representative for internal technical group discussionsDrive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute 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 complianceMay be required to perform other duties as assignedQualificationsBachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical disciplineMin 3 years experience ideally in manufacturing, preferably GMP SettingDemonstratable experience of leading technical related projectsEvidence of continuous professional development is desirableKnowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessityKnowledge of regulatory/code requirements to Irish, European and International Codes, Standards and PracticesReport, standards, policy writing skills requiredEquipment and process validationSterile filling processes and equipmentProficiency in Microsoft Office and job-related computer applications requiredExcellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner