Equipment Specialist

4 settimane fa

Milan, Italia Tensive A tempo pieno

Tensive is a biomedical company that is developing an innovative scaffold aiming to improve breast cancer patients’ quality of life, by offering a natural breast reconstruction.

We are looking for an Equipment Specialist who will be responsible for managing all production and R&D equipment, ensuring their optimal performance through comprehensive maintenance, qualification processes (Installation, Operational, and Performance Qualification – I/O/PQ) and calibration. This role includes drafting and reviewing maintenance procedures, and actively proposing solutions to enhance equipment management and optimize the overall production process. The specialist plays a critical role in maintaining the efficiency, safety, and compliance of the company’s operations.

We love to hire collaborative and self-motivated people with a passion for learning and a teamwork spirit.

Our team invests heavily in coaching new hires.

Responsibilities

The Equipment Specialist:

  1. Ensures the continuous efficiency, functionality, and safety of production and Research and Development (R&D) equipment, machinery, and tools, in compliance with internal procedures and by liaising with external companies when necessary and authorized.
  2. Develops an appropriate maintenance strategy to ensure production continuity and the desired levels of equipment/instrument availability.
  3. Manages routine and extraordinary maintenance of equipment and machinery, in accordance with procedures.
  4. Collaborates in defining and monitoring maintenance-related KPIs.
  5. Manages the implementation of company software, their validation, and the monitoring of related licenses.
  6. Provides 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.
  7. Proposes initiatives aimed at optimizing equipment and machinery, supporting company functions in identifying and implementing improvement actions.
  8. Monitors and ensures the continuous efficiency of safety and alarm devices to prevent injuries and damage to workers, machines, and equipment.
  9. Participates in preparing the company for inspections by Competent Authorities and contributes to their successful outcome by collaborating on the implementation of any corrective actions.
  10. Identifies actions to ensure continuous updates and role adequacy in relation to new required knowledge.
  11. Drafts and updates Standard Operating Procedures (SOPs) and written operating instructions regarding the maintenance of company facilities, equipment, and machinery.
  12. Executes and manages validation activities related to machinery, utilities, and instruments under the supervision of the Chief responsible and in collaboration with relevant company functions; oversees 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.
  13. Collaborates in the management of non-conformities within their area of responsibility.
  14. Collaborates in the management of preventive and corrective actions within their area of responsibility.
Requirements
  1. Diploma as an industrial or technical expert in electrical or mechanical industries, or a degree in engineering disciplines.
  2. Precision, reliability, and the ability to work independently.
  3. At least 2 years of experience in the manufacturing environment.
  4. Practical experience in the use and maintenance of production and laboratory tools for chemical and biological activities.
  5. Knowledge of quantitative and qualitative approaches, as well as the organizational, operational, and technical aspects of businesses.
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