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Maintenance and Qualification Engineer

Engineering, Maintenance and Technical Services Unit

IRBM is a scientific contract research organization (CRO) that stands at the forefront of drug discovery, leveraging a single, unified research facility, located in Pomezia (Rome), Italy, to accelerate team-based breakthroughs and improve efficiencies from initial concept to pre-clinical candidate.

With a history of contributing to several approved drugs, and its own internal pipeline of oncology and other therapeutic assets, IRBM is powered by deep collaborations and decades of expertise from leading global institutions. Our comprehensive in-house capabilities assist partners in achieving key milestones and progressing towards clinical readiness, positioning IRBM as a major player in driving innovation in the pharmaceutical and biotech fields.

IRBM Group also has a GMP – certified Contract Development and Manufacturing Organization (CDMO), ADVAXIA Biologics. ADVAXIA is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) and is compliant with the FDA and EMA regulatory guidelines.

Job Description

We have an opening for a highly motivated Maintenance and Qualification Engineer to join our Engineering, Maintenance and Technical Services Unit. Reporting to the Unit Director, the incumbent will be involved in coordinating and implementing maintenance programs for scientific equipment (GMP and non GMP applications), 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.

Competencies/skills:

  • Expertise in scientific equipment for R&D and GMP applications;
  • Extensive experience in the maintenance and metrology of scientific equipment;
  • Strong background in the installation, commissioning and start up of scientific equipment for new projects;
  • Well-established knowledge and experience in project management principals and practices;
  • Proven experience in GMP environments, including the validation and life cycle management of computerized systems;
  • Flexibility and adaptability in dynamic work environments;
  • Proactive mindset with a strong team-building spirit;
  • Strong interpersonal skills for effective collaboration;
  • Analytical and detail-oriented approach to tasks;
  • Results-driven personality with high level of enthusiasm, energy and confidence;
  • Strong organizational skills to manage multiple tasks efficiently;
  • Effective problem solving abilities;
  • Ability to work well under pressure.

Qualifications

  • 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)

During the job interview we will evaluate candidates’ experience and the job offer will be commensurate.

We thank all applicants for their interest, candidates selected for interviews will be contacted.

IRBM considers all qualified applicants without discrimination, including on the basis of race, gender, age, disability, gender identity or expression, national origin, religion, sexual orientation, or other protected classes. We nurture an inclusive culture where everyone can show their full potential and enjoy a fulfilling career.

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