Lavori attuali relativi a Equipment Specialist - Milano, Lombardia - Tensive
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Milano, Lombardia, Italia Tensive A tempo pienoJob DescriptionTensive is a biomedical company that is developing an innovative scaffold to improve breast cancer patients' quality of life. We are seeking a skilled Equipment Specialist to manage our production and R&D equipment, ensuring optimal performance through comprehensive maintenance, qualification processes, and calibration.The ideal candidate will...
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Mechanical Engineer Equipment Specialist
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Equipment Specialist
2 mesi fa
Tensive is a biomedical company that specializes in developing innovative medical solutions to improve the quality of life for patients with breast cancer. Our mission is to provide cutting-edge technology and expertise to support the development of natural breast reconstruction solutions.
Job DescriptionWe are seeking an experienced Equipment Specialist to join our team. The successful candidate will be responsible for managing all production and R&D equipment, ensuring their optimal performance through comprehensive maintenance, qualification processes, and calibration. This role includes drafting and reviewing maintenance procedures, and actively proposing solutions to enhance equipment management and optimize the overall production process.
Key Responsibilities- Equipment Maintenance and Management: Ensure the continuous efficiency, functionality, and safety of production and R&D equipment, machinery, and tools, in compliance with internal procedures and by liaising with external companies when necessary and authorized.
- Maintenance Strategy Development: Develop an appropriate maintenance strategy to ensure production continuity and the desired levels of equipment/instrument availability.
- Routine and Extraordinary Maintenance: Manage routine and extraordinary maintenance of equipment and machinery, in accordance with procedures.
- Maintenance-Related KPIs: Collaborate in defining and monitoring maintenance-related KPIs.
- Software Implementation and Validation: Manage the implementation of company software, their validation, and the monitoring of related licenses.
- Malfunction Intervention: Provide prompt intervention in the event of malfunctions or anomalies in the production process and R&D equipment and machinery, with the goal of minimizing downtime.
- Equipment Optimization: Propose initiatives aimed at optimizing equipment and machinery, supporting company functions in identifying and implementing improvement actions.
- Safety and Alarm Devices: Monitor and ensure the continuous efficiency of safety and alarm devices to prevent injuries and damage to workers, machines, and equipment.
- Inspection Preparation: Participate in preparing the company for inspections by Competent Authorities and contribute to their successful outcome by collaborating on the implementation of any corrective actions.
- Knowledge Updates: Identify actions to ensure continuous updates and role adequacy in relation to new required knowledge.
- Standard Operating Procedures: Draft and update Standard Operating Procedures (SOPs) and written operating instructions regarding the maintenance of company facilities, equipment, and machinery.
- Validation Activities: Execute and manage validation activities related to machinery, utilities, and instruments under the supervision of the Chief responsible and in collaboration with relevant company functions; oversee the qualification and validation of new equipment, machinery, and tools, particularly ensuring the correct execution of required functionality and calibration tests, as well as pre-startup and startup trials.
- Non-Conformity Management: Collaborate in the management of non-conformities within their area of responsibility.
- Preventive and Corrective Actions: Collaborate in the management of preventive and corrective actions within their area of responsibility.
- Education: Diploma as an industrial or technical expert in electrical or mechanical industries, or a degree in engineering disciplines.
- Skills: Precision, reliability, and the ability to work independently.
- Experience: At least 2 years of experience in the manufacturing environment.
- Practical Experience: Practical experience in the use and maintenance of production and laboratory tools for chemical and biological activities.
- Knowledge: Knowledge of quantitative and qualitative approaches, as well as the organizational, operational, and technical aspects of businesses.