Process Engineer

Process Engineer - Contract - Ireland With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Leinster. This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US. Essential Duties and Responsibilities for this role include, but are not limited to, the following:Lead/execute production floor-based activitiesParticipate on a team of engineersPlan and execute C&Q, validation activities as requiredDesign & develop engineering studiesProvide technical input into quality notification by authoring/reviewing/approving investigationsExecution of equipment/qualification validation programs; including re-qualification and re-validationPerform data analysis and make informed decisions/recommendations around conclusions reached from data analysisStatistical data analysis to support development and commercialisation batchesSupport continuous improvement through Lean Six Sigma methodologiesLeading and active participation in projects, system failure investigations and investigation reportsPerform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issuesParticipate and/or lead cross functional or single function teams including liaising with vendors or above site groupsRequirements:Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical disciplinePrior related work experience; ideally in manufacturing, preferably GMP SettingTypically have 5 years related work experience in Aseptic manufacturing / process engineeringKnowledge of regulatory/core 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 requiredLean Six Sigma Methodology experience desiredExcellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated mannerIf you are interested initially, please apply now for immediate consideration and further information. #LI-CH3