Wanted! Maintenance Engineer Equipment! Do you want to make the world a little better? Do you have experience with validation in the pharmaceutical industry? Then we are looking for you!
Job description Maintenance Engineer Equipment
As Maintenance Engineer Equipment you will play a critical role in the asset maintenance management of our process and manufacturing equipment in a vaccine manufacturing plant.
Your main responsibility will be to lead the asset maintenance management of our critical GMP manufacturing equipment. You will be part of a multidisciplinary team of maintenance specialists in which you will;
Serve as the Maintenance Subject Matter Expert for a number of systems across the production platform.
Support the maintenance supervisory team together with the other equipment engineer in setting up, aligning and improving operational maintenance processes like; RCM, spare part management, maintenance and calibration contracting and execution.
Interact with peer functions in related support departments like; Operations, Engineering, Process Engineering, Quality Assurance to assure efficient and reliable technical support to our customers.
Participate in the EVM 24/7 support team which means that on a regular basis (once every 6 weeks) you will be available for first line support outside normal working hours.
Your key responsibilities as Maintenance Engineer are:
Deploy and coordinate equipment maintenance in order to ensure compliance with Good Maintenance and Manufacturing Practices.
Functions as the maintenance equipment expert in our multi-disciplinary team and as equipment SME during external inspections or audits.
Lead/support Maintenance/feasibility studies.
Planning and coordination of preventive, corrective and replacement maintenance activities.
First/second line troubleshooting in case of technical problems.
Spare part control and availability.
Handling of compliance records (Change controls, Events, CAPA, Deviations).
Preparation, organization and coordination of yearly maintenance/calibration activities on equipment.
Handling of maintenance, calibration and requalification documentation in a GMP environment.
Represent maintenance in projects.
Support continuous improvement projects within EVM department (e.g. ME2).
Perform RCM on equipment.
Perform component impact assessments to identify criticality of instruments/components.
Perform the SME role on the assigned equipment.
Lead/support improvement and modification projects on equipment.
Requirements Maintenance Engineer Equipment
The requirements for this role are:
Bachelor degree preferably in one of the following disciplines: Mechanical Engineering, Electrical Engineering, Installation Technics or Process Engineering.
Specific knowledge and experience:
Understanding of regulatory requirements and industry guidelines specific for the pharmaceutical industry and the maintenance & engineering scope (e.g., GMP, RCM, NEN3140, VCA, CE, etc.)
Knowledge of pharmaceutical and/or bioprocessing equipment which are used in upstream and downstream manufacturing processes.
Affinity with Project management.
You have experience in supporting other engineers, technicians and guiding of external contractors.
Skills and passion for fault finding and troubleshooting.
You have a minimum of 2-4 years work experience as Maintenance Engineer. You are familiar with documents and processes within the pharmaceutical industry.
You are a good communicator in the Dutch and English language, both verbally and in writing.
Experience within a maintenance organization in a process/biotechnology/healthcare or pharmaceutical (GMP) environment.
Experience with SAP-PM/QM or another Enterprise software system.
Experience with disposable technologies (e.g. Bioreactors or filtration systems).
The offer Maintenance Engineer Equipment
You will join an innovative biotech company with a global presence. You will work in multidisciplinary teams of dedicated and talented individuals with a common goal: to make the world a healthier place!