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