Job Title:
About the Role:
We are seeking a skilled Process Engineer to join our team in Carlow, Ireland. As a key member of our production team, you will be responsible for supporting multiple capital projects taking place onsite.
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.
Key Responsibilities:
* 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 authorizing/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
Requirements:
* 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