Job Summary:
We're seeking a skilled Visual Inspection Process Engineer to join a leading global biopharmaceutical company based in the Southeast of Ireland on an initial 12-month contract. In this position the person will play an integral role within the Product Supply Unit's team, ensuring reliable supply of syringe and vial products to patients globally while interfacing with various departments, such as MSAT, Technical Development, Quality Assurance, and Supply Chain.
Key responsibilities:
Provide process engineering support to the Product Supply APU.
Support delivery of continuous improvement projects to existing equipment.
Lead and coordinate elements of an automated inspection project and contribute to process engineering activities related to the development of new and existing manufacturing capacity.
Utilization of knowledge gained from existing manufacturing technologies to aid in the development of new technologies with the goal of implementing higher output and yield.
Ensure safety compliance, providing technical and engineering support for process and equipment failures, identifying, and implementing process and product improvements, supporting qualification of new products/processes, analyzing machine performance data, and managing improvement projects within budget and time constraints with a distinct focus on AVI inspection.
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.
Key Requirements:
Degree in an Engineering discipline (Mechanical, Manufacturing, Chemical, or related field).
Experience in a highly regulated GMP (Good Manufacturing Practice) environment.
Strong problem-solving and critical thinking skills.
Excellent communication and cross-functional collaboration skills.
Strong documentation, protocol generation, and execution skills.
Automation experience with vision systems is desirable.
3+ years of experience in pharmaceutical or medical device manufacturing preferred.
Demonstrated experience in process validation, equipment qualification (IQ/OQ/PQ), and change control.
Familiarity with data analysis tools and methodologies (e.g., Minitab, Six Sigma, SPC).
Working knowledge of regulatory requirements (e.g., FDA, EMA, ICH guidelines).
Experience with SCADA, PLCs, HMI interfaces, and control systems in automated production environments.
Ability to manage multiple priorities in a fast-paced production environment.
Project management skills with experience leading cross-functional teams.
Understanding of lean manufacturing principles and continuous improvement methodologies.
Knowledge of equipment and processes related to syringe/vial filling, visual inspection, and secondary packaging is a plus.
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