We're looking for a Senior Engineer Equipment in Leiden with experience in a biotech environment. Are you the experienced engineer that can handle the responsibility for the technical support of all utilities, production and laboratory areas? Please get in touch for an exploratory conversation.
As the Senior Maintenance Engineer Equipment you are part of a young, motivated and dynamic team (≈30) responsible for the technical support of all utilities, production and laboratory areas and all involved equipment.
You will work in a challenging environment where great progress is made in commercializing 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.
As Maintenance Engineer Equipment you will play a critical role in the asset life cycle of the process equipment in vaccine manufacturing plants:
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 across the production platform.
Support the management team in setting up, aligning and improving operational maintenance processes during the asset life cycle.
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.
Function as first point of contact for maintenance related topics.
Your key responsibilities:
Function as the maintenance equipment expert in our multi-disciplinary team.
Deploy and coordinate equipment maintenance in order to ensure compliance with Good Maintenance and Manufacturing Practices.
Lead/support as equipment SME during external inspections, audits and/or handling of compliance records.
Lead/support feasibility, implementation and improvement projects.
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.
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 4-6 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.
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!