**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 in compliance with safety and regulatory standards.
• 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