Maintenance Engineer
h3Job Description /h3pPrevia verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo : /ph3OBJECTIVES/PURPOSE /h3ulliProvides maintenance engineering support for pharmaceutical production equipment, with a specific process and technical focus on sterile filling lines, isolator technology, vial washers , depyrogenation tunnels, stopper processors, autoclaves. /liliActs as a technical interface between Maintenance and Process Engineering, combining equipment reliability and maintenance expertise with a solid understanding of aseptic filling processes and contamination-control requirements. /liliSupports troubleshooting on corrective and preventive maintenance activities, in accordance with EHS and GMP rules, for GmP/non-GmP equipment /systems at the Pisa site, in support of production and filling plans. /liliProvides support on spare-parts management, maintenance documentation, maintenance contract review, SOP review within the assigned area of expertise. /li /ulh3ACCOUNTABILITIES /h3ulliSupports the Maintenance Department in ensuring safe, compliant and reliable performance of assigned pharmaceutical equipment, with particular attention to sterile filling and isolator systems and ancillary systems. /liliWorks closely with Process Engineering to investigate production problems, recurring alarms, stoppages, process deviations and performance losses involving sterile filling equipment. /liliSupports troubleshooting, RCA, technical investigations, CAPA and continuous improvement in accordance with EHS, cGMP, Quality and Data Integrity requirements. /liliComplies with EHS requirements and supports their implementation during maintenance activities.Supports the team in promoting the culture of operational safety and procedures development. /liliWorks with RCM tools, dashboards and data analytics to increase OEE of filling line. /liliSupports spare-parts management for assigned equipment, including criticality assessment, identification of technical requirements, notification of system or inventory gaps and proposal of improvements.
/liliDevelops and maintains strong technical knowledge of the assigned equipment and process, including operating principles, critical parameters, equipment documentation, interfaces and failure modes. /liliCoordinates and technically supervises suppliers and contractors for maintenance, specialist support, service visits and improvement activities, ensuring compliance with EHS and site requirements. /li /ulh3CORE ELEMENTS RELATED TO THIS ROLE /h3ulliMaintenance role with a differentiated process-engineering orientation and specialist focus on sterile filling technology, while keeping an olistic perspective on site activities. /liliActs as a technical interface between Maintenance and Process Engineering for isolators, aseptic filling equipment, vial washers and depyrogenation tunnels. /liliField-oriented contributor able to connect process behaviour, machine functionality, maintenance history and compliance requirements. /liliContributes to site capability building through technical support, knowledge sharing, documentation, structured troubleshooting and dissemination of lessons learned. /li /ulh3DIMENSIONS AND ASPECTS /h3h3Technical/Functional (Line) Expertise /h3ulliApplies engineering knowledge to maintenance and process-related issues on sterile pharmaceutical equipment. /liliSupports equipment reliability, maintenance strategy, technical documentation, validated-state maintenance and compliance with cGMP, EHS and Data Integrity requirements. /li /ulh3Leadership /h3ulliPromotes technical excellence, safe behaviours and structured problem solving /liliCollaborates with cross-functional teams for problem solving and technical implementation / assessment /li /ulh3Decision-making and Autonomy /h3ulliPerforms assigned activities autonomously within approved procedures, defined priorities and the boundaries of the role. /liliEvaluates technical evidence,
proposes actions and escalates significant risks and decisions to the Maintenance Lead and relevant Process Engineering or Quality stakeholders. /li /ulh3Interaction /h3ulliMaintains regular interaction with Maintenance, Process Engineering, Production, Quality, Automation, Reliability, EHS, Validation and external suppliers. /li /ulh3Innovation /h3ulliUses equipment data, failure history and process observations to identify recurring issues and propose sustainable improvements. /li /ulh3Complexity /h3ulliOperates in a regulated sterile-manufacturing environment where equipment reliability, aseptic-process performance, validated state, safety and production continuity are closely interconnected. /li /ulh3EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS /h3ulliMaster's or Bachelor's degree in Chemical, Mechanical, Industrial, Automation, Pharmaceutical or other relevant Engineering discipline. /liliApproximately 2-4 years of relevant professional experience in pharmaceutical process engineering, maintenance engineering, equipment engineering or technical support, including practical experience with sterile filling equipment and isolator technology. /liliA process-engineering educational background or demonstrated process-engineering experience in sterile filling operations and isolator technology is preferred. /liliStructured troubleshooting and field-oriented problem-solving capabilities. /liliFluent in English /liliPrioritization and project-management skills /liliAbility to manage simultaneous activities, competing priorities, and challenges /liliAbility to influence through technical competence, collaboration and clear communication. /li /ulh3Locations /h3pITA - Pisa /ph3Base Salary Range /h3p€34,300.00 - €47,080.00 /ppThe estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. /ph3Benefits /h3h3Worker Type /h3pEmployee /ph3Worker Sub-Type /h3pRegular /ph3Time Type /h3pFull time /p #J-18808-Ljbffr
/liliDevelops and maintains strong technical knowledge of the assigned equipment and process, including operating principles, critical parameters, equipment documentation, interfaces and failure modes. /liliCoordinates and technically supervises suppliers and contractors for maintenance, specialist support, service visits and improvement activities, ensuring compliance with EHS and site requirements. /li /ulh3CORE ELEMENTS RELATED TO THIS ROLE /h3ulliMaintenance role with a differentiated process-engineering orientation and specialist focus on sterile filling technology, while keeping an olistic perspective on site activities. /liliActs as a technical interface between Maintenance and Process Engineering for isolators, aseptic filling equipment, vial washers and depyrogenation tunnels. /liliField-oriented contributor able to connect process behaviour, machine functionality, maintenance history and compliance requirements. /liliContributes to site capability building through technical support, knowledge sharing, documentation, structured troubleshooting and dissemination of lessons learned. /li /ulh3DIMENSIONS AND ASPECTS /h3h3Technical/Functional (Line) Expertise /h3ulliApplies engineering knowledge to maintenance and process-related issues on sterile pharmaceutical equipment. /liliSupports equipment reliability, maintenance strategy, technical documentation, validated-state maintenance and compliance with cGMP, EHS and Data Integrity requirements. /li /ulh3Leadership /h3ulliPromotes technical excellence, safe behaviours and structured problem solving /liliCollaborates with cross-functional teams for problem solving and technical implementation / assessment /li /ulh3Decision-making and Autonomy /h3ulliPerforms assigned activities autonomously within approved procedures, defined priorities and the boundaries of the role. /liliEvaluates technical evidence,
proposes actions and escalates significant risks and decisions to the Maintenance Lead and relevant Process Engineering or Quality stakeholders. /li /ulh3Interaction /h3ulliMaintains regular interaction with Maintenance, Process Engineering, Production, Quality, Automation, Reliability, EHS, Validation and external suppliers. /li /ulh3Innovation /h3ulliUses equipment data, failure history and process observations to identify recurring issues and propose sustainable improvements. /li /ulh3Complexity /h3ulliOperates in a regulated sterile-manufacturing environment where equipment reliability, aseptic-process performance, validated state, safety and production continuity are closely interconnected. /li /ulh3EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS /h3ulliMaster's or Bachelor's degree in Chemical, Mechanical, Industrial, Automation, Pharmaceutical or other relevant Engineering discipline. /liliApproximately 2-4 years of relevant professional experience in pharmaceutical process engineering, maintenance engineering, equipment engineering or technical support, including practical experience with sterile filling equipment and isolator technology. /liliA process-engineering educational background or demonstrated process-engineering experience in sterile filling operations and isolator technology is preferred. /liliStructured troubleshooting and field-oriented problem-solving capabilities. /liliFluent in English /liliPrioritization and project-management skills /liliAbility to manage simultaneous activities, competing priorities, and challenges /liliAbility to influence through technical competence, collaboration and clear communication. /li /ulh3Locations /h3pITA - Pisa /ph3Base Salary Range /h3p€34,300.00 - €47,080.00 /ppThe estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. /ph3Benefits /h3h3Worker Type /h3pEmployee /ph3Worker Sub-Type /h3pRegular /ph3Time Type /h3pFull time /p #J-18808-Ljbffr