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.
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 (mAb) 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.
Execute engineering activities in compliance with safety and regulatory standards.
Develop process and operational control strategies, including writing FMEA documents and training operators.
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.
Skills and Experience Required: 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.
Skills: Engineer pharmaceutical Manufacturing