Job Description

Previa 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

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

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, aseptic-process performance, validated state, safety and production continuity are closely interconnected.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

<

📌 Maintenance Engineer (Ospedaletto)
🏢 Takeda Pharmaceutical
📍 Ospedaletto