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The Role
Reporting to the Program Lead, the Process & Technology Engineer/Scientist is responsible for the development, qualification, control and optimization of the new Chromatography Media manufacturing processes.
Duties Include:
1. Develop knowledge & expertise in the new Chromatography Media manufacturing process in order to become a subject matter expert & key member of the new product introduction team. This will include collaboration with U.S. based R&D colleagues.
2. Assist with the fit out of a small scale lab in the Media manufacturing area. This task includes feasibility trials & qualification of the lab scale interleaver, flow reactor and critical point dryer.
3. Support the program by assisting with conversion of the small-scale lab process into a commercially viable large-scale operation.
4. Assist with development, installation & qualification of full scale production equipment to include interleaving machine, flow reactor and critical point dryer. This includes trial work to determine process windows prior to qualifications.
5. Involvement in all qualification activities for the full scale production process. These activities will include feasibility trials, engineering batches, OQ & PQ runs.
6. Identify, develop, and implement improvement projects, using lean six sigma tools where appropriate.
7. Support the implementation of product data collection systems and analytical techniques such as SPC, FMEA, Risk Assessments and DOE.
8. Evaluate new technology and raw materials which may be considered for use.
9. New raw material characterisation / validation.
10. Lead investigations into any process, product, and quality issues to achieve long term solutions. This includes technical support and contact with external R&D personnel. Use of Root Cause Analysis methodology, and implementation of robust corrective and preventative actions.
11. The initiation, co-ordination and completion of capital and process development projects within the Media manufacturing plant, using structured approach and detailed planning to deliver projects that meet or exceed stakeholder expectations and that are delivered Right First Time, safely, on schedule and within budget.
12. Support the management of the plant BoMs and COR systems. Develop expertise in SAP ERP system.
13. Responsible for the development, introduction and operation of process monitoring/control system and procedures. Review of data to identify trends, weaknesses etc.
14. Maintain and develop process documentation and procedures.
15. Support of the Natrix A program stakeholders: Quality, Validation, Maintenance, EHS etc to achieve all team objectives.
16. Ensure that process information is recorded in a Process Knowledge document and ensure that this document is updated as necessary to reflect increased process knowledge and understanding as the program progresses.
17. Ensure compliance with GMP and Safety rules on all new and existing equipment & processes.
Who You Are
Degree in Chemistry/Chemical/Process Engineering or equivalent. A postgraduate qualification in one of these disciplines would be an advantage.
Working Knowledge of some of the following would be an advantage but not a requirement:
1. Leadership & Influencing Skills.
2. Change Agent.
3. A Demonstrated Commitment to Safety and Quality.
4. Automated control loop design and optimization.
5. Process trending and data extraction software.
6. Minitab/ Lean 6 Sigma techniques.
7. Root Cause Analysis methodology.
8. Strong Project Management Capabilities.
9. Microsoft Excel to an advanced level.
10. Microbiological & Aseptic Design requirements in GMP manufacturing.
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