Process Engineer Job Opportunity
This is a fantastic chance to work in a cutting-edge fill-finish facility and contribute to the development of life-changing oncology treatments.
The ideal candidate will be responsible for leading and executing production floor-based activities, participating in a team of engineers, and planning and executing C&Q, validation activities as required. They will also design and develop engineering studies, provide technical input into quality notifications, and execute equipment qualification programs.
Key Responsibilities include:
* 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
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