This leading global biologics organisation provides comprehensive integrated and customisable services to the biopharmaceutical and related industry sectors from contract development services to contract manufacturing services. Recently, this business has announced expansions into regions such as the U.S and Ireland, where significant investment has been undertaken to build a new cell culture green-field manufacturing site. Once built, this manufacturing site will be the largest single-use biologics manufacturing plant globally and will employ around 400 staff. This site has been designed to run continuous bio-processing, a next-generation manufacturing technology which will be implemented for the first time at this site.
With this expansion, an exciting opportunity has arisen for a Process Scientist to join the team. As a key member of the manufacturing technology team, the Process Scientist focuses on process monitoring, troubleshooting which includes leading/supporting major process investigations. The process scientist will also be a key role in implementing cost reduction projects and facility/ equipment design reviews and improvements.
Duties and responsibilities of the Process Scientist will include:
- Interface with the project teams to ensure the manufacturing facility will operate as per the user requirements.
- Provide expertise in the design, commissioning and qualification of the new manufacturing facility at the site through to commercialisation.
- 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.
- 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 CAPA's and performance improvements, conduct investigation trending as required.
- 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.
- Support audit preparation.
You will have skills and experience in the following:
- Third level qualification in a Science or Engineering related subject.
- 4+ years relevant experience in a large-scale in a Biopharmaceutical/pharmaceutical facility.
- Thorough knowledge of current Good Manufacturing Practices (cGMP).
- Familiarity with Chromatography and Ultra filtration production operations is required.
- Excellent focus and attention to detail.
- Excellent communication skills including computer literacy and ability to work independently and in team
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.