OPERATIONS - ENGINEERING/PRODUCTION
Operation Supervisor - Life sciences - M/V/X
Permanent contract
Position Summary
As the CAR T Techlance facility continues to increase its production capacity we are looking for a Production Support Engineer. As the Production Support Engineer you hold a pivotal role in the design maintenance and continuous improvement of well-defined operational support activities within manufacturing. These activities encompass but are not limited to:
Pre-Processing activities like sterilization (internal and external) and kitting (internal and external) Non-Cell Processing Related Materials (a.o. consumables artwork gowning)
Site Risk Assessment Management
Access Rights Management
Order Management
Tasks and responsibilities
You take ownership of and will handle all related requirements including the following responsibilities:
Liaison between Ghent operations and pre-processing activities (sterilization and kitting) facilitating communication resolving issues optimizing processes and ensuring seamless collaboration to enhance overall production efficiency.
Drive continuous improvement. Regularly track and analyze key performance indicators (KPIs) to assess production efficiency material usage (scrap and yield) quality (NCs) and delivery (OOS lead times). Support & lead projects in line with site objectives and to drive continuous improvement in close collaboration with supporting departments.
Develop review and approve robust operational documentation framework of the operational supporting activities including operating procedures work instructions etc. and ensure adequate training of the organization. Perform operational assessment for changes.
Participate in the Change Control/Technical Board meetings and in Operational Performance Review meetings with focus on continuous improvement of the operational supporting activities. Contribute to root cause investigations and develop review approve (and own) robust CAPA plans.
Life sciences
Profile:
Preferably a minimum of 10 years established experience within either MSAT Quality or Operations. Ideally experience in 2 or more of these settings.
Engineering or Scientific education to Master level or equivalent through experience. Strong stakeholder management skills and ability to communicate to various departments and help navigate differing priorities to ensure deadlines are met.
Fluent in Dutch and English.
Willingness to work on site 5 days per week. Limited home work may be an option once fully up and running in role.
Project management experience or training would be an advantag
Europe Belgium Flanders Flemish Brabant
5 to 10 years
Required Experience:
Manager
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