Maintenance And Qualification Engineer
2 settimane fa
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.
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.
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