Job Overview
The Process Engineer will provide engineering support to existing operations and continuous improvement initiatives within the pre-filled syringe manufacturing process.
This role involves supporting monoclonal antibody (m Ab) commercial production, technology transfer of new products, and capacity expansion, all within a sterile manufacturing environment.
Main Responsibilities:
* Act as a Process Engineer for projects and programs associated with pre-filled syringe operations.
* Develop and optimize filter testing, fill weight cycles, and cleaning verification procedures.
* Generate and execute documentation, including recipe documents, FMEAs, protocols, and reports.
* Lead problem-solving investigations and own change controls.
* Ensure project activities are completed on schedule and within budget.
* Support daily syringe filling operations by investigating and resolving technical issues.
* Liaise with material and component vendors as required.
* Coordinate deliverables to meet project timelines and cost targets.
* Generate detailed hour-by-hour schedules for planning and execution.
* Support commercial manufacturing by meeting key performance metrics (SQDCI).
* Participate in site GMP, regulatory, and safety audits.
* Provide technical support for process improvements, new product introductions, and production activities.
* Travel to other sites or vendor locations as required.
Requirements:
* Honours degree in an Engineering discipline.
* Minimum of 3 years' relevant experience in a highly regulated GMP environment.
* Strong problem-solving skills.
* Experience in sterile manufacturing operations is an advantage.
* Knowledge of syringe filling processes is a distinct advantage.
* Experience in new product introductions is beneficial.
About Our Client
Our client is a leading biologics company that continues to grow and diversify to serve patients worldwide.
Their site in Waterford comprises almost 800 employees who work together at a state-of-the-art biopharmaceutical and medical device campus.