Summary:
An Automated Visual Inspection Process Engineer is required for a biopharmaceutical company in Waterford.
The successful candidate will support the introduction of Automated Visual Inspection (AVI) activities for pre-filled syringe products.
There is a range of inspection process from manual processes through to high-speed, high volume AVI.
Responsibilities:
New recipe development and optimization for AVI machine for prefilled syringes.
Supporting FAT-SAT-qualification and PQ activities for AVI.
Evaluate and support vision system issues.
Liaison with vendor, global SMEs, Engineering group to ensure AVI process has minimum false rejects.
Working with process experts and quality group to ensure compliance of AVI process with the global standards and regulatory agency requirements.
Support new product introductions and capacity expansions, including new vendor selections, maintenance planning, design changes, change controls, OEE improvement, yield improvement, etc.
Lead systematic technical root cause investigations.
Support all company safety and quality programs and initiatives.
Qualifications & Experience:
Degree in science or Engineering discipline.
4+ years experience in a highly regulated GMP environment.
Background and experience in Automated visual inspection is desired.
Understanding of visual inspection standards and some experience with regulatory inspection is desired.
Skills:
GMP Automated visual inspection visual inspection standards regulatory inspection AVI