Job description
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.
