Position Summary

As the CAR T Techlance facility continues to increase it's 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.

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 advantage
Senioriteitsniveau
Medewerker
Branche
IT-services en consultancy
Productie industriële machines
Productie medische apparatuur
Soort baan
Fulltime
Functies
Productie
Productmanagement
Consultancy
Vaardigheden
 
Productieondersteuning
Orderbeheer
Unix
Probleemoplossing
Oracle-database
Shellscripts schrijven
Productie-efficiëntie
JIRA
Stakeholdermanagement