
Website TPM05683
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.
To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.