Place of work
Department: Engineering, Maintenance & Technical Service
Main Activities expected by the Job:
- Coordinate Maintenance (Preventive and Extraordinary) Activities in Sterile Areas with High levels of housekeeping to conform to cGMP standards to maintain the quality of the product, assembling and disassembling of equipment before and after use, and performing Maintenance Activities by following proper procedures.
- Oversee the maintenance and repair of a wide range of mechanical systems and equipment, including but not limited to HVAC, cleanrooms, autoclaves, utilities (clean & black) and production equipment such as reactors, milling, filter dryers, freeze dryers, filling machines.
- Lead, train, and mentor a team of maintenance technicians, fostering a culture of safety, excellence, and accountability.
- Supports the Mechanical Maintenance Manager in the management of the relationships with equipment suppliers and service vendors for the procurement of spare parts and external maintenance services.
- Maintain detailed records of maintenance activities, work orders, and equipment history to support audit readiness developing and monitoring KPI to minimize downtime and ensures the reliability of critical production equipment.
- Investigate and solve mechanical equipment failures through root cause analysis and implement preventive measures to avoid future issues.
- Collaborates with the Mechanical Maintenance Manager in identifying opportunities for continuous improvement of existing procedures, processes or equipment.
- Supports the Mechanical Maintenance Manager in developing and managing the maintenance budget, ensuring cost-effective strategies for equipment upkeep and upgrades.
- Support the Production and Engineering Department in drafting, reviewing and checking of Functional Specifications for New Projects and Improvements in the Site for the area of expertise
- Support the Technical Service Managers for validation, requalification and calibration strategies to comply with regulations and GMP standards
- Cooperate and proactively Support other Departments of the Site on technical matters
Technical Skills expected by the Job:
- Proven experience in mechanical maintenance management within a pharmaceutical or sterile production environment.
- Strong knowledge of aseptic and sterile production processes and equipment.
- Excellent problem-solving and troubleshooting abilities.
- Knowledge of regulatory requirements, including cGMP.
- Budget management experience.
Behavioral Skills Expected by the Job:
- Demonstrated leadership and team management skills.
- Exceptional organizational and communication skills.
- Willingness to adapt to changing priorities and handle multiple tasks simultaneously.
- Excellent attention to detail and organizational skills.
Computer Skills expected by the Job :
- Excellent Office Suite.
- Knowledge of SAP PM will be consireed a plus.
- Proficiency in using computer software for data analysis and documentation.
Languages Skills expected by the Job :
- Excellent Italian both written and spoken.
- Good English both written and spoken.
Mandatory Requirements of the Job :
- Bachelor’s degree in Mechanical Engineering
- Prior experience of 5 years in maintenance in the pharmaceutical or biotechnology industry.