As a Quality Engineer you are part of a small team of professionals in a GMP environment. You take care of the execution and coordination of main engineering activities including maintenance, calibration and qualification.
You will give support to both sites Maastricht and Geleen. You have functional relationships with colleagues in Manufacturing, Quality Control and Quality Assurance and you report to the Head of Facilities, Engineering and ICT.
Tasks and results:
- Execution of all required preventive, breakdown and cleaning maintenance, (re)calibration and (re)qualification activities.
- Perform small engineering and maintenance activities by monitoring utilities, systems and equipment status.
- Counseling and instructing contractors for maintenance, calibration and qualification of all individual systems.
- Prepare and write controlled or qualification documents and technical reports related to validation, calibration and maintenance.
- Operate the Building Management System and the Equipment Management System and associated installations. First contact person for equipment and system status and all breakdowns.
- Provide first line support on request for technical assistance.
- Provide first line support on request for technical assistance in the fields of facilities, equipment and ICT
- Report non-compliances and deviations to superior.
- Bachelor in Mechanical and/or Electrical Engineering (HBO)
- More than 3 years’ hands-on experience in Engineering or Maintenance position, preferably in Pharmaceutical or Biotech Industry
- Preferably experience with (pharmaceutical) utilities such as HVAC, purified water, clean steam, equipment like LAFC, autoclave and systems like EMS and BMS
- Preferably knowledge of GMP regulations and affinity with ICT
- Excellent communication skills in Dutch and English, both verbally and in writing
- Pro-active, service and team oriented attitude, capable of working independent
- Analytical and creative problem-solver, including definition and resolution
- Ability to work on multiple projects under time pressure
- Quality awareness
- Team player, eager to contribute to the success of a new area of drug development