Project 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 activities
- Participate on a team of engineers
- Plan and execute C&Q, validation activities as required
- Design & develop engineering studies
- Provide technical input into quality notification by authoring / reviewing / approving investigations
- Execution of equipment / qualification validation programs; including re-qualification and re-validation
- Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis
- Statistical data analysis to support development and commercialisation batches
- Support continuous improvement through Lean Six Sigma methodologies
- Leading and active participation in projects, system failure investigations and investigation reports
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues
- Participate and / or lead cross functional or single function teams including liaising with vendors or above site groups
Requirements :
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.
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