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Maintenance and Qualification Specialist

2 mesi fa

Pomezia, Lazio, Italia IRBM A tempo pieno
Job Title: Maintenance and Qualification Engineer

We are seeking a highly skilled Maintenance and Qualification Engineer to join our Engineering, Maintenance and Technical Services Unit at IRBM. As a key member of our team, you will be responsible for coordinating and implementing maintenance programs for scientific equipment, preparing technical specifications, and managing equipment lifecycles.

Key Responsibilities:
  • Prepare detailed technical specifications and user requirements for maintenance and qualification programs, as well as for assigned projects;
  • Manage the execution of maintenance, qualification, and validation contracts, ensuring all tasks are completed efficiently;
  • Monitor project costs and manage changes to stay within budget;
  • Develop and oversee work order plans for maintenance activities;
  • Supervise external contractors involved in the repair and preventive maintenance of scientific equipment;
  • Ensure timely execution of qualification and calibration programs for GMP applications;
  • Oversee the validation plan execution for computerized systems used in GMP applications;
  • Supervise new equipment introduction projects, coordinating activities with contractors and external resources;
  • Facilitate seamless maintenance handover to scientific equipment technicians;
  • Coordinate qualification and validation activities related to new equipment for GMP applications;
  • Support Quality Management System (QMS), including deviation management, change control, CAPA, and risk assessment for the ADVAXIA GMP Unit;
  • Meticulously review, organize, and archive technical documentation;
  • Prepare periodic maintenance reports and calculate key performance indicators (KPIs) for continuous improvement.
Requirements:
  • Master's degree in engineering (mechanical, mechatronic, electronic, electrical, or information technology);
  • Minimum experience of 7 years in the sector;
  • Good knowledge (written and spoken) of the English language;
  • Autonomy with the main applications of MS Office;
  • Basic knowledge of Autocad;
  • Knowledge of CMMS software (in particular Microsoft Navision Dynamics) would be a plus.

The position is based at Pomezia (RM). IRBM considers all qualified applicants without discrimination and nurtures an inclusive culture where everyone can show their full potential and enjoy a fulfilling career.