AVI – Process Engineer

Role Summary:

• Our client, based in Co. Waterford is looking for an Automated Visual Inspection Process Engineer to join their biopharmaceutical facility.
• Vision expert is a key role in supporting 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.
• The role will be based on Co. Waterford site and there will be opportunity to learn and leverage from other network sites and global Subject Matter Experts (SMEs)

Core Duties and 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.

Minimum Qualifications and Experience:

• Degree in Science or Engineering discipline.
• Minimum 1 – 2 years of experience in a similar role required
• Background and experience in Automated visual inspection is desired
• Experience in a highly regulated GMP environment
• Strong problem-solving and communication skills.
• Understanding of visual inspection standards and some experience with regulatory inspection is desired.

Please note, we do not require agency assistance with this role.