Job Title: Senior Process Development Engineer
We are seeking an experienced Senior Process Development Engineer to join our team in Galway. The successful candidate will have a strong background in new product introduction and manufacturing process development.
The ideal candidate will have:
* Bachelors degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering or related field.
In addition to the above qualifications, the following skills and experience are highly desirable:
* 27 years of manufacturing engineering experience.
* Hands-on experience with process validation and documentation.
This role involves ensuring that products are manufactured efficiently safely and compliantly. Key responsibilities include creating process flow diagrams work instructions standard operating procedures SOPs leading executing process validation activities IQ/OQ/PQ ensuring compliance with FDA regulations ISO 13485 GMP requirements supporting audits inspections quality system maintenance collaboration troubleshooting equipment processes support design for manufacturability DFA efforts root cause investigations corrective actions CAPA application Lean Six Sigma methodologies knowledge.