Maintenance Engineer Equipement
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.
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
• Lead/support improvement and modification projects on equipment
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 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)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Vincent van Straten.
The Company
Big Pharmaceutical company.Role Description
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.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.
Responsibilities
Your key responsibilities:• 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
• Lead/support improvement and modification projects on equipment
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
Requirements
- 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)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Vincent van Straten.
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