Job Title: Project Engineer
This is a fantastic opportunity to work on a state-of-the-art fill-finish facility and our company's first stand-alone vaccine and biologics plant outside the US.
About The Job
* Lead/execute production floor-based activities.
* Participate on a team of engineers responsible for planning, executing C&Q, validation activities as required.
* Design & develop engineering studies to support development and commercialisation batches.
* Provide technical input into quality notifications 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.
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.
Our Company Offers
We are committed to providing an environment where you can grow professionally and personally.
A competitive salary package and benefits will be offered to the right candidate.
The successful candidate will be based at our site in Ireland.