Maintenance Engineer - Sterile Filling & Isolator Technology

Takeda Pharmaceutical; Ospedaletto; In loco; EUR 34.000 - 47.000; Tempo pieno

Descrizione del lavoro

Takeda Pharmaceutical Co. in Pisa is seeking a Maintenance Engineer specializing in sterile filling lines and isolator technology.

You will support maintenance of aseptic equipment, work with Process Engineering on problems, and ensure cGMP/EHS compliance and data integrity. The role emphasizes RCA, CAPA and continuous improvement, with responsibility for coordinating suppliers and maintaining OEE to support production continuity.

Competenze

• Must have practical experience with sterile filling equipment and isolator technology.
• Fluent in English (B2-C1).
• 2-4 years of relevant professional experience in pharmaceutical process/maintenance engineering.

Mansioni

• Supports maintenance and reliability of sterile pharmaceutical equipment and isolator systems.
• Interacts with Process Engineering to troubleshoot production problems and deviations.
• Executes RCA, CAPA and continuous improvement in line with EHS, cGMP and Data Integrity requirements.
• Coordinates suppliers/contractors for maintenance work and service visits.

Conoscenze

Maintenance engineering

Interface with Process Engineering

Troubleshooting

Regulatory compliance

Project management

Formazione

Master's or Bachelor's degree in Chemical/Mechanical/Industrial/Automation/Pharmaceutical Engineering

Strumenti

RCM tools

Dashboards

Data analytics

Descrizione del lavoro

Job Description

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, 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 Engineering discipline.
• 2-4 years of relevant professional experience in pharmaceutical process engineering, maintenance engineering, equipment engineering or technical support
• Must: practical experience with sterile filling equipment and isolator technology.
• Fluent in English (B2-C1)
• A process-engineering educational background or demonstrated process-engineering experience in sterile filling operations and isolator technology is preferred.
• Structured troubleshooting and field-oriented problem-solving capabilities.
• Prioritization and project-management skills
• Ability to manage simultaneous activities, competing priorities, and challenges
• Ability to influence through technical competence, collaboration and clear communication.

Locations

ITA - Pisa

Base Salary Range:

€34,300.00 - €47,080.00

The 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.

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time