30 ott - Pisa
Takeda Pharmaceutical
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.
* Coordinate 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.
* Approximately 2-4 years of relevant professional experience in pharmaceutical