Maintenance Engineer
Job Description
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Maintenance Engineer – Sterile Filling & Isolator Technology
OBJECTIVES/PURPOSE
-
- Provides 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.
- Acts 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.
- Supports 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.
- Provides support on spare-parts management, maintenance documentation, maintenance contract review, SOP review within the assigned area of expertise.
ACCOUNTABILITIES
-
- Supports 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.
- Works closely with Process Engineering to investigate production problems, recurring alarms, stoppages, process deviations and performance losses involving sterile filling equipment.
- Supports troubleshooting, RCA, technical investigations, CAPA and continuous improvement in accordance with EHS, cGMP, Quality and Data Integrity requirements.
- Complies with EHS requirements and supports their implementation during maintenance activities. Supports the team in promoting the culture of operational safety and procedures development.
- Works with RCM tools, dashboards and data analytics to increase OEE of filling line.
- Supports spare-parts management for assigned equipment, including criticality assessment, identification of technical requirements, notification of system or inventory gaps and proposal of improvements.
- Develops and maintains strong technical knowledge of the assigned equipment and process, including operating principles, critical parameters, equipment documentation, interfaces and failure modes.
- Coordinates and technically supervises suppliers and contractors for maintenance, specialist support, service visits and improvement activities, ensuring compliance with EHS and site requirements.
CORE ELEMENTS RELATED TO THIS ROLE:
-
- Maintenance role with a differentiated process-engineering orientation and specialist focus on sterile filling technology, while keeping an olistic perspective on site activities.
- Acts as a technical interface between Maintenance and Process Engineering for isolators, aseptic filling equipment, vial washers and depyrogenation tunnels.
- Field-oriented contributor able to connect process behaviour, machine functionality, maintenance history and compliance requirements.
- Contributes to site capability building through technical support, knowledge sharing, documentation, structured troubleshooting and dissemination of lessons learned.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
-
- Applies engineering knowledge to maintenance and process-related issues on sterile pharmaceutical equipment.
- Supports equipment reliability, maintenance strategy, technical documentation, validated-state maintenance and compliance with cGMP, EHS and Data Integrity requirements.
Leadership
-
- Promotes technical excellence, safe behaviours and structured problem solving
- Collaborates with cross-functional teams for problem solving and technical implementation / assessment
Decision-making and Autonomy
-
- Performs assigned activities autonomously within approved procedures, defined priorities and the boundaries of the role.
- Evaluates technical evidence, proposes actions and escalates significant risks and decisions to the Maintenance Lead and relevant Process Engineering or Quality stakeholders.
Interaction
-
- Maintains regular interaction with Maintenance, Process Engineering, Production, Quality, Automation, Reliability, EHS, Validation and external suppliers.
Innovation
-
- Uses equipment data, failure history and process observations to identify recurring issues and propose sustainable improvements.
Complexity
-
- Operates in a regulated sterile-manufacturing environment where equipment reliability, asepti
È questo il suo prossimo lavoro? Legga la descrizione completa qui sotto per scoprirlo e non esiti a candidarsi.
Maintenance Engineer – Sterile Filling & Isolator Technology
OBJECTIVES/PURPOSE
-
- Provides 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.
- Acts 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.
- Supports 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.
- Provides support on spare-parts management, maintenance documentation, maintenance contract review, SOP review within the assigned area of expertise.
ACCOUNTABILITIES
-
- Supports 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.
- Works closely with Process Engineering to investigate production problems, recurring alarms, stoppages, process deviations and performance losses involving sterile filling equipment.
- Supports troubleshooting, RCA, technical investigations, CAPA and continuous improvement in accordance with EHS, cGMP, Quality and Data Integrity requirements.
- Complies with EHS requirements and supports their implementation during maintenance activities. Supports the team in promoting the culture of operational safety and procedures development.
- Works with RCM tools, dashboards and data analytics to increase OEE of filling line.
- Supports spare-parts management for assigned equipment, including criticality assessment, identification of technical requirements, notification of system or inventory gaps and proposal of improvements.
- Develops and maintains strong technical knowledge of the assigned equipment and process, including operating principles, critical parameters, equipment documentation, interfaces and failure modes.
- Coordinates and technically supervises suppliers and contractors for maintenance, specialist support, service visits and improvement activities, ensuring compliance with EHS and site requirements.
CORE ELEMENTS RELATED TO THIS ROLE:
-
- Maintenance role with a differentiated process-engineering orientation and specialist focus on sterile filling technology, while keeping an olistic perspective on site activities.
- Acts as a technical interface between Maintenance and Process Engineering for isolators, aseptic filling equipment, vial washers and depyrogenation tunnels.
- Field-oriented contributor able to connect process behaviour, machine functionality, maintenance history and compliance requirements.
- Contributes to site capability building through technical support, knowledge sharing, documentation, structured troubleshooting and dissemination of lessons learned.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
-
- Applies engineering knowledge to maintenance and process-related issues on sterile pharmaceutical equipment.
- Supports equipment reliability, maintenance strategy, technical documentation, validated-state maintenance and compliance with cGMP, EHS and Data Integrity requirements.
Leadership
-
- Promotes technical excellence, safe behaviours and structured problem solving
- Collaborates with cross-functional teams for problem solving and technical implementation / assessment
Decision-making and Autonomy
-
- Performs assigned activities autonomously within approved procedures, defined priorities and the boundaries of the role.
- Evaluates technical evidence, proposes actions and escalates significant risks and decisions to the Maintenance Lead and relevant Process Engineering or Quality stakeholders.
Interaction
-
- Maintains regular interaction with Maintenance, Process Engineering, Production, Quality, Automation, Reliability, EHS, Validation and external suppliers.
Innovation
-
- Uses equipment data, failure history and process observations to identify recurring issues and propose sustainable improvements.
Complexity
-
- Operates in a regulated sterile-manufacturing environment where equipment reliability, asepti