Job Overview
We are seeking a dedicated Manufacturing Process Specialist to support our day-to-day production within the Biotools manufacturing areas. This role involves effectively implementing change management projects and providing technical support for processing issues or changes on existing manufacturing processes.
* The ideal candidate will have a strong background in engineering, preferably within the Medical Device industry or other regulated environments.
* They must be proficient in root cause analysis methodology and process validation procedures.
* A bachelor's degree in Mechanical/BioMedical/Process Engineering is required.
* The successful candidate will possess excellent verbal, written, and interpersonal communication skills.
About the Role
This position is primarily responsible for troubleshooting various manufacturing process issues using root cause analysis methodology. The specialist will investigate process, product, and quality issues to achieve long-term solutions and identify opportunities for improvement based on manufacturing data such as OEE and Yield.
* Key responsibilities include conducting feasibility trials/process DOE's to determine appropriate/robust process windows and preparing associated protocols, developing and executing plans, and compiling relevant reports.
* The specialist will also maintain and develop manufacturing process documentation and procedures.
Requirements
* Bachelor's degree in Mechanical/BioMedical/Process Engineering or similar.
* 5 years engineering experience, preferably within Medical Device industry or other regulated environments.
* Working knowledge of Product & Process validations essential.
* Excellent verbal, written, and interpersonal communication skills.