We're seeking a highly skilled Process Engineer to join our team in the start-up of our European manufacturing site in Athenry. This is an exciting opportunity to make a significant impact on the development and implementation of manufacturing processes.
In this role, you will be responsible for implementing, characterizing, improving, and qualifying/validation of manufacturing processes for replicate manufacturing equipment used in the scale-up of new or existing products. You will lead and support equipment/process qualifications including protocol development and execution.
Key responsibilities include:
* Improving and optimising manufacturing process/assembly steps and operating procedures for replicate equipment and processes within a regulated quality system
* Leading and supporting equipment/process qualifications including protocol development and execution
* Developing and maintaining project timelines and providing updates and feedback to project leadership
* Implementing problem solving skills and techniques to identify potential process risks, assess their impact, developing and implementing mitigation plans
* Planning and performing Design of Experiments (DOE) and utilising six sigma methodologies to characterise, assess capabilities, and determine optimal processing operating windows
* Consulting with vendors to produce equipment, materials, and/or parts that meet determined product specifications
* Performing statistically robust and industry standard analysis of data, and presenting findings to technical teams
What makes you successful:
* A Bachelor's degree in a technical discipline, and a minimum of 13+ years related experience or a Master's degree and 8+ years equivalent industry experience or a PhD and 5+ years of experience
* The ability to run self-directed projects, maintain timelines, stay organised, and balance multiple activities in a fast-paced environment
* The ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things
* Proven ability to work hands-on in a fast-paced environment
* Familiarity with experimental design, data analysis, and interpretation of experiments; JMP experience or Minitab preferred
* Excellent communication (written and verbal) and personal interaction skills
* Knowledge of high reliability, high volume manufacturing processes and designs
Benefits:
* A front row seat to life-changing CGM technology
* A full and comprehensive benefits program
* Growth opportunities on a global scale
* Access to career development through in-house learning programs and/or qualified tuition reimbursement
To be considered for this role, please submit your application along with your resume and cover letter.