Janssen Vaccines & Prevention B.V. is a global biotech company which is part of the Johnson & Johnson family of companies. Within this family the company focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the company.
Due to the continued growth of the EVM department and expansion of our responsibilities we are currently seeking for a fulltime;
The Engineering-Validation-Maintenance (EVM) department (> 30 persons) is a young, motivated and dynamic team responsible for the technical support of all utilities, production and laboratory areas and all involved equipment on the Janssen Vaccines & Prevention site Leiden.
We work in a challenging environment where we make great progress in commercializing our vaccines. Engineering has a large project portfolio to improve the existing environment. The Validation group looks after the correct qualification and validation status of GMP critical equipment and processes. The key-focus point of the maintenance group is asset maintenance management of all assets within JVP.
As Maintenance Engineer Equipment you will play a critical role in the asset maintenance management of our process and manufacturing equipment in our vaccine manufacturing plant “Valerio”.
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.
- 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.
- Perform RCM on equipment.
- Perform component impact assessments to identify criticality of instruments/components.
Education: Bachelor degree preferably in one of the following disciplines: Mechanical Engineering, Electrical Engineering, Installation Technics or Process Engineering.
- 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
- 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)
- 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.
- Strong communicator and good in building relations
- Quality oriented & critical Mind-set
- Planning & Organizing
- Strong team player
Apply directly for this position if you want the part of this great team!
Janssen Vaccines & Prevention BV (8852)