Maintenance Engineer

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.
• Co‑ordinates 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, aseptic‑process performance, validated state, safety and production continuity are closely interconnected.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Master's or Bachelor's degree in Chemical, Mechanical, Industrial, Automation, Pharmaceutical or other relevant Eng