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Maintenance Engineer Equipment Pharmaceutical

Locatie

Leiden

Publicatiedatum

31-05-2019

Opdrachtgever

Independent Recruiters Groep BV

Maintenance Engineer Equipment Pharmaceutical

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.

Preferebly:

  • 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!
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