Automated Visual Inspection Process Engineer
The Automated Visual Inspection (AVI) Process Engineer plays a vital role in supporting the introduction and optimization of AVI activities for pre-filled syringe products. This involves collaborating with manual processes and high-speed, high-volume AVI systems while ensuring compliance with global standards and regulatory requirements.
Key Responsibilities:
* Develop and optimize new recipes for AVI machines for prefilled syringes.
* Support FAT, SAT qualification, and PQ activities for AVI.
* Evaluate and resolve issues related to the vision system.
* Liaise with vendors, global SMEs, and the Engineering group to ensure minimal false rejects in the AVI process.
* Work with process experts and the quality group to ensure AVI compliance with global standards and regulatory requirements.
* Support new product introductions and capacity expansions, including vendor selections, maintenance planning, design changes, change controls, OEE, and yield improvements.
* Lead systematic technical root cause investigations.
* Support company safety and quality programs and initiatives.
Requirements:
* Experience in a highly regulated GMP environment.
* Degree in Science or Engineering discipline.
* Strong problem-solving and communication skills.
* Experience in Automated Visual Inspection is desired.
* Understanding of visual inspection standards and some experience with regulatory inspection is preferred.