Critical System Engineer
Pubblicato il 05-08-2026 - Takeda Pharmaceutical in Rieti
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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 e/o lavoratori delle aziende del territorio di riferimento coinvolte da tavoli di crisi attivi presso il MIMIT.
OBJECTIVES/PURPOSE:
- Act as System Owner 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.
- Promote and develop optimization and continuous improvement initiatives for process equipment/ systems, turning opportunities into technical proposals supported by Business Case (incl. TCO analysis) and a data-driven approach.
- Execute and coordinate (within the assigned scope) project execution for initiatives and projects, contributing to deliverables throughout the project life cycle (e.g., URS, FAT/ SAT, commissioning, qualification/ validation, handover).
- Contribute the development of critical system capacity models to identify critical utilities capacity bottlenecks supporting GMP manufacturing processes/production processes.
- Support for management of site utilities budget.
ACCOUNTABILITIES:
- Perform 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.
- Manage quality change control 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.
- Perform 3rd level troubleshooting 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).
- Support project execution 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.
- Manage assigned small projects as end-to-end PM (within the defined scope): definition of technical scope, activity scheduling, coordination of stakeholders and suppliers/ contractors, control of timelines/ costs and deliverable quality.
- Formulate scope of work and RFx Packages for plant equipment vendors, critical system engineering consultants, and architectural/engineering services, including commissioning services and subcontractors.
- Identify optimization and improvement opportunities on equipment/ systems (efficiency, reliability, downtime reduction, robustness), propose prioritized initiatives and develope Business Case (incl. TCO) to support investment decisions and value creation.
- Support Capacity Modeling through data collection/ validation, input updates and contribution to identifying constraints/ capacity bottlenecks for the area of competence, ensuring the quality of shared information.
- Development and standardization of energy management and sustainability of Critical System in Rieti Facility.
- Participation in energy saving and environmental impact improvement projects.
- Support EHS/ Process Safety activities (e.g., participation in PHA-Hazop) as technical representative within the area of competence, preparing evidence and technical inputs consistent with required expectations.
- Ensure transfer of knowledge to the Maintenance & Reliability Engineering group, through structured knowledge sharing, documentation, training sessions and technical alignment to support asset reliability and long-term maintainability.
CORE ELEMENTS RELATED TO THIS ROLE:
- Operational System Ownership: direct responsibility for technical governance and lifecycle of assigned assets/ equipment, with strong focus on compliance, traceability and long-term robustness.
- Execution & Delivery: 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.
- Small Projects PM: ability to manage small projects end-to-end (scope/ schedule/ cost/ quality) with structured escalation.
- Improvement and Value Creation: attitude to identify opportunities,
propose solutions and contribute to Business Case/ TCO for optimization initiatives.
- Capacity Modeling: contribution to data quality and model updates within own scope, supporting site analyses and decisions.
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise
Technical 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).
Leadership
Individual Contributor role; ownership on assigned activities, ability to influence stakeholders and work within project teams; clear and solution-oriented communication.
Decision-making and Autonomy
Autonomy 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).
Interaction
Interactions 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.
Innovation
Search for robust and sustainable solutions; application of lessons learned and standardization; data-driven approach for diagnosis and optimization, with attention to traceability and compliance.
Complexity
Regulated 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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Engineering degree required (Chemical, Biochemical, Mechanical or Industrial engineering is preferred) and experience in a GMP/ GxP environment.
- Skills: technical writing, structured problem solving (RCA), risk-based thinking, planning and prioritization, cross-functional collaboration, supplier management, effective communication and ability to clearly share/ escalate.
- Basic/ 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
Locations
ITA - Rieti
Base Salary Range:
€34,300.00 - €47,080.00
For information about our benefits, please click here.
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Tempo pieno