Job Posting

Critical System Engineer

Rieti, Italy

Rieti, Italy| Santa Rufina, Italy

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Job ID R0185945 Category Manufacturing Engineering Subcategory Manufacturing & Supply Business Unit Plasma-Derived Therapies Job Type Full time

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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 projectsas 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