Process Engineer, Sterile Fill Finish Waterford We are currently recruiting a Process Engineer for a major biopharmaceutical manufacturing organisation based in Waterford.

This position will provide technical leadership across sterile manufacturing operations, with particular emphasis on aseptic fill-finish, lyophilisation, process optimisation and technical problem resolution.
The successful candidate will work closely with manufacturing, engineering, quality, development and external stakeholders to improve process performance, support new product introductions and maintain robust, compliant manufacturing operations.
Responsibilities

• Provide technical leadership and process support to sterile manufacturing operations.
• Optimise aseptic fill-finish and lyophilisation processes.
• Lead technical investigations, root-cause analysis and problem resolution.
• Support deviations, complaints, CAPAs and change controls, ensuring effective and timely closure.
• Act as a process SME for critical process parameters and product quality attributes.
• Design and execute process-development studies, plant trials and experimental programmes.
• Apply Design of Experiment and statistical techniques to process optimisation.
• Lead cycle-time reduction and continuous-improvement initiatives.
• Support visual inspection process development and improvement.
• Contribute to capital-project implementation and equipment introduction.
• Support scale-up, technology-transfer and new product introduction programmes.
• Provide technical support for clinical supply and product-enhancement projects.
• Develop, implement and monitor manufacturing performance metrics.
• Maintain technical and quality documentation in a current and compliant state.
• Ensure all activities are completed in accordance with cGMP requirements.

• Degree in Chemical Engineering, Process Engineering, Industrial Engineering or a related discipline.
• An advanced qualification in Pharmaceutics, Pharmacy or a related scientific discipline would be advantageous.
• Strong experience within pharmaceutical or biopharmaceutical manufacturing.
• Practical aseptic fill-finish manufacturing experience is required.
• Lyophilisation or freeze-drying experience is desireable.
• Demonstrated experience leading process investigations and structured RCA.
• Experience with deviations, CAPAs and pharmaceutical quality systems.
• Knowledge of process development, DoE and statistical analysis.
• Previous exposure to NPI, scale-up or technology transfer would be advantageous.
• Strong technical report-writing and communication skills.