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:
- 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
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