ph3Job Description /h3pPrevia 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 e/o lavoratori delle aziende del territorio di riferimento coinvolte da tavoli di crisi attivi presso il MIMIT. /ph3OBJECTIVES/PURPOSE /h3ulliAct as bSystem Owner: /b for assigned assets/ equipment, supporting quality change control and the management of complex technical issues, contributing with analysis, recommendations and implementation of structural solutions through escalation and approvals according to the defined governance. /liliPromote and develop boptimization and continuous improvement initiatives: /b for process equipment/ systems, turning opportunities into technical proposals supported by Business Case (incl. TCO analysis) and a data-driven approach. /liliExecute and coordinate (within the assigned scope) bproject execution: /b for initiatives and projects, contributing to deliverables throughout the project life cycle (e.g., URS, FAT/ SAT, commissioning, qualification/ validation, handover). /liliContribute the development of bcritical system capacity models: /b to identify bcritical utilities capacity bottlenecks: /b supporting GMP manufacturing processes/production processes. /liliSupport for bmanagement of site utilities budget: /b. /li /ulh3ACCOUNTABILITIES /h3ulliPerform the System Owner role for assigned assets/ equipment maintain and update governance documentation (specifications, applicable technical standards, set points/ ranges where applicable, acceptance criteria, change history), ensuring completeness, quality and traceability. /liliManage bquality change control: /b operationally (within the assigned scope) preparation of technical content, support to risk assessment, definition of impacts and requirements, contribution to the test/ qualification strategy where applicable. /liliPerform b3rd level troubleshooting: /b on complex/ recurring issues related to assets/ equipment within scope advanced diagnosis, data analysis, definition of technical options/ alternatives and recommendations, and manage implementation (change, upgrade, re-qualification). /liliSupport bproject execution: /b for major site projects, contributing to Critical System Engineering work packages URS, technical inputs for vendor selection, FAT/ SAT support and qualification/ validation, preparation/ review of the handover package, punch list/ issue management and follow-up of actions. /liliManage assigned bsmall projects: /b bas end-to-end PM: /b (within the defined scope)



definition of technical scope, activity scheduling, coordination of stakeholders and suppliers/ contractors, control of timelines/ costs and deliverable quality. /liliFormulate bscope of work and RFx Packages: /b for plant equipment vendors, critical system engineering consultants, and architectural/engineering services, including commissioning services and subcontractors. /liliIdentify boptimization: /b and bimprovement: /b opportunities on equipment/ systems (efficiency, reliability, downtime reduction, robustness), propose prioritized initiatives and develope Business Case (incl. TCO) to support investment decisions and bvalue creation: /b. /liliSupport bCapacity Modeling: /b through data collection/ validation, input updates and contribution to identifying constraints/ capacity bottlenecks for the area of competence, ensuring the quality of shared information. /liliDevelopment and standardization of benergy management and sustainability: /b of Critical System in Rieti Facility. /liliParticipation in benergy saving and environmental impact improvement projects.: /b /lilibSupport EHS/ Process Safety: /b activities (e.g., participation in PHA-bHazop: /b) as technical representative within the area of competence, preparing evidence and technical inputs consistent with required expectations. /liliEnsureb transfer of knowledge: /bto the Maintenance Reliability Engineering group, through structured knowledge sharing, documentation, training sessions and technical alignment to support asset reliability and long-term maintainability. /li /ulh3CORE ELEMENTS RELATED TO THIS ROLE /h3ullibOperational System Ownership: /b direct responsibility for technical governance and lifecycle of assigned assets/ equipment, with strong focus on compliance, traceability and long-term robustness. /lilibExecution Delivery: /b strong orientation to deliverable quality and execution discipline (change, projects, handover), with ability to work in cross-functional teams and manage issues/ punch list with contractors and suppliers. /lilibSmall Projects PM: /b ability to manage small projects end-to-end (scope/ schedule/ cost/ quality) with structured escalation. /lilibImprovement and Value Creation: /b attitude to identify opportunities, propose solutions and contribute to Business Case/ TCO for optimization initiatives. /lilibCapacity Modeling:



/b contribution to data quality and model updates within own scope, supporting site analyses and decisions. /li /ulh3DIMENSIONS AND ASPECTS /h3h3Technical/Functional (Line) Expertise /h3pTechnical competencies on equipment/ and process systems in a GxP environment; ability to define requirements, interpret data, produce high-quality technical documentation and contribute to change/ projects (URS, FAT/ SAT, commissioning, qualification/ validation, handover). Ability to contribute to optimization initiatives through technical and economic evaluations (Business Case/ TCO). /ph3Leadership /h3pIndividual Contributor role; ownership on assigned activities, ability to influence stakeholders and work within project teams; clear and solution-oriented communication. /ph3Decision-making and Autonomy /h3pAutonomy in execution and in owning the assigned scope; ability to propose technical alternatives and manage escalation within own organization for high-impact decisions (compliance, safety, costs, timelines, test/ qualification strategy). /ph3Interaction /h3pInteractions with Production, QA, Validation/ Qualification, Automation, IT, Reliability/ Maintenance, Procurement, suppliers and contractors; participation in project teams and technical meetings for requirements alignment, progress and issue management. /ph3Innovation /h3pSearch for robust and sustainable solutions; application of lessons learned and standardization; data-driven approach for diagnosis and optimization, with attention to traceability and compliance. /ph3Complexity /h3pRegulated and multi-stakeholder context; simultaneous management of system ownership, change, projects (execution and small projects PM) and technical support, with impacts on compliance, business continuity and planning. /ph3EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS /h3ulliEngineering degree required (Chemical, Biochemical, Mechanical or Industrial engineering is preferred) and experience in a GMP/ GxP environment. /liliSkills technical writing, structured problem solving (RCA), risk-based thinking, planning and prioritization, cross-functional collaboration, supplier management, effective communication and ability to clearly share/ elevate. /liliBasic/ operational knowledge to perform the accountabilities GMP/ GxP, quality change control, URS, FAT/ SAT, qualification/ validation, handover package, issue management, Business Case and TCO principles, forecasting/ cost tracking basics, Hazop analysis, capacity modeling tools /li /ulh3Locations /h3pITA - Rieti /ph3Base Salary Range /h3p€34,300.00 - €47,080.00 /ph3Worker Type /h3pEmployee /ph3Worker Sub-Type /h3pRegular /ph3Time Type /h3pFull time /p /p #J-18808-Ljbffr

📌 Critical System Engineer (Rieti)
🏢 Takeda
📍 Rieti