Job Description
As an Aseptic Manufacturing Engineer, you will have the opportunity to work on a state-of-the-art fill-finish facility and our first stand-alone vaccine and biologics plant outside the US. You will lead/execute production floor-based activities, participate in 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, execute 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.
Required Skills and Qualifications
* Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other technical discipline
* Prior related work experience; ideally in manufacturing, preferably GMP Setting
* Typically have 5 years related work experience in Aseptic manufacturing / process engineering
* Knowledge of regulatory/core 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
* Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
Benefits
This is a fantastic opportunity to grow your career and gain valuable experience in the field of aseptic manufacturing.
Others
As an Aseptic Manufacturing Engineer, you will be part of a dynamic team that is passionate about delivering high-quality products to our customers.