Maintenance Engineer Pharmaceutical
||Independent Recruiters Groep
||maandag 25 november 2019
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!
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.
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).
A global player in the field of biotech developments in Leiden. The company produces the Ebola and HIV vaccins!
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! You are offered a salary between €3.000 - €4.000 gross monthly