Job DescriptionProduction Engineer
£40,518 – £50,646
My client based in Billingham specialise in developing and manufacturing processes for customer’s biologic drugs and offering stability studies to support customer drug substance and drug products.
Currently They are embarking upon a significant site expansion project to expand the capacity of our large-scale microbial manufacturing facility. They are looking for a Production Engineer to initially help with the process transfer, equipment qualification and facility start up with a longer term view that this person is then the process and equipment SME, and able to provide on plant support, problem solving and to lead the project through a successful PPQ campaign. A continuous improvement mindset is essential to drive process efficiencies and increase asset utilisation.
Role and Responsibilities
- Has developed a sound working knowledge of facility equipment, utility systems and supporting Quality systems through operational experience and theoretical understanding of the purpose of each system. This experience is used to provide Technical Support during manufacture and to support maintenance and engineering activities as required.
- Ensures all tasks and activities conducted in the manufacturing facilities are performed in accordance with the relevant Environmental, Health and Safety and cGMP regulations.
- Has a deep understanding of the bio manufacturing excellence programme and the operations vision. Demonstrates practical application of the vision using deployment plans and performance measures.
- Promotes use of potential problem analysis (PPA) to predict and mitigate against potential manufacturing deviations affecting quality or schedule adherence.
- Regularly spend time on plant (GEMBA), coaching the manufacturing team to become the eyes and ears of maintenance (Production Technologist Mind).
- Observes the performance of the cleanroom environment, determining trends and driving investigations to root cause. Uses observation to coach and mentor the manufacturing teams to improve standards, deploying tools such as 5S and 5C to promote good control.
- Develops and implements error proofing solutions to simplify day to day operations and support the goal of leaving no doubt.
- Leads investigations into STOP and DELAY time using appropriate root cause analysis and the 5C system. Supports implementation of countermeasures and preventative actions as required.
- Develops and deploys visual management tools to support the goal of status-at-a-glance.
- Develops and owns roll out of production technologist mind project, supporting the desired behaviours and coaching the manufacturing team in their understanding.
Please apply ASAP for immediate consideration.