This company is a leading global biopharmaceutical manufacturer, with over 5,000 employees worldwide. Their focus is on becoming a leader in patient medicines across the world. They currently operate in the US, EU, Asia and Israel. They operate out of one of the most advanced manufacturing plants in all of Europe, just outside of Dublin.
This Process Scientist will be a key member of the manufacturing technology team, focusing on process monitoring, troubleshooting and leading investigations. They must have a focus on cost reduction also.
We seek to continuously optimise our processes to improve our capability and quality standards.
Provide expertise in the design, commissioning and qualification of the new manufacturing facility at "The Company" through to commercialisation ensuring all necessary plans are executed and delivered on time.
Interface with the project teams to ensure the manufacturing facility will operate as per the user requirements.
Provide technical knowledge in establishing the commercial process and routine manufacturing operations by serving as a commercial manufacturing process subject matter expert.
Subject Matter Expert (SME) when troubleshooting process issues during start-up, tech transfer activities and commercial operations. S/he will work closely with the expanded manufacturing team ensuring any actions and plans are clearly accounted for and carried out in alignment of plant operations plans.
Identify process improvement projects and implementation and work with the team to prioritise projects/support demands from the Business Unit.
Write APQR and process impact assessments to support investigation closure as applicable.
Implement process CAPAs and performance improvements, conduct investigation trending as required
Coach manufacturing personnel to increase technical knowledge of critical process steps and develops plans to build competencies and expertise.
Participate in safety, process and environmental investigations. Reviews alert and action limits as needed and implement corrective action as appropriate.
Ensure investigations are closed on time, recurring deviations are tracked, and that root cause and effective CAPA are identified and implemented.
Change Control write up and close out
Participate in cross-functional project teams as applicable
Maintain role as Process Guardian. Responsible for analysis of routine statistical process control charts.
Support audit preparation
Introduction of new or alternate consumables or raw materials
Work to implement a culture of Right-First Time through partnerships with manufacturing shift teams and provide leadership in the use of OpEx principles to optimise technical and business processes.
Support the disposition process. Ensure all data ready in a timely fashion in support of business unit disposition metric.
Perform additional duties at the request of the direct manager.
- 3-4 years' experience in a major Bio/Pharmaceutical manufacturing facility
- Experience in GMP
- Experience in Lean or process optimisation
- 3rd Level related degree