Salary Range

Salary Range: €45,300.00 - €84,100.00

Job Description Summary

Job Description Summary

Location

Location: Ivrea, Italy #onsite

Role Purpose

The Senior Expert Engineering is part of the TRD RLT Engineering organization and in particular in the Colleretto Giacosa Pilot Plant team, providing technical and maintenance expertise, coordination and execution for the management of all Pilot Plant equipment and facility&utilities;, in order to ensure the asset expected performances in terms of safety, quality, productivity, efficiency and flexibility, in full compliance with all HSE and GxP relevant requirements.

Job Description Main Activities

Strategy

- Support plant strategy execution ensuring technical reliability, continuous improvement and compliance with HSE and quality requirements
- Execute assigned projects according to expected deliverables and quality, life cycle costs and project schedules
- Ensure state of the art technical solutions according compliance standards and HSE regulations including radioprotection regulations
- Responsible for the technical availability, reliability, and condition of the production plants
- Participate in the definition and implementation of the maintenance strategy, program, and budget
- Participate in sharing and leveraging of best practices and expertise within the Novartis engineering community
- Lead the implementation of technology strategy and the approved equipment standards and project execution standards
- Apply initiatives and strategies from global improvement programs and engineering standards and push and support roll out and implementation




- Ensure needed flexibility for TRD processes is applied to the Colleretto Giacosa plant

Leadership & Organization

- Provide engineering expertise and technical leadership to the rest of the team and broader organization
- Ensure technical know-how is correctly built and shared along the TRD RLT network
- Provide technical training and mentoring to Pilot Plant and Operations team members
- Coordinate and lead external resources from engineering and maintenance service providers
- Coordinate and manage equipment and systems suppliers as needed

Quality & Compliance

- Support internal and external audits
- Ensure compliance with Quality Manual / Quality Modules / Standard Procedures
- Implement global SOPs and Standards
- Create and manage site specific SOPs/WPs & templates
- Manage investigations, deviation handling, CAPAs implementation, Change Control executions and Quality events as relevant

Maintenance & Calibration

- Drive / improve technical availability, reliability, and condition of assets
- Develop, monitor and improve KPI for engineering
- Establish/support cost efficient repair and maintenance processes in compliance with local regulations, HSE, GMP
- Define and execute asset strategy and proper asset lifecycle management, calibration, re-qualification and maintenance plans included




- Manage maintenance improvement projects and initiatives
- Create and control maintenance / calibration budget, drive efficiencies

System & Tools

- Manage, coordinate centrally shared systems/ databases and provide professional infrastructure for design, installation, qualification and lifecycle management of facilities and equipment
- Act as system owner for assigned systems
- Use of CAD systems and other engineering digital tools
- Support the use and handling of Asset Management tools (SAP, CMX, Kneat, etc.)

Ideal Background Education (minimum/desirable)

- Minimum degree in Engineering (industrial field) or equivalent
- Desirable MSc in Engineering (industrial field) or equivalent

Languages

- Proficiency in Italian, fluent in English

Experience / Professional Requirement

- At least 7 years in Plant Engineering or similar in pharmaceutical field or other comparable highly regulated field
- Resource coordination as well as maintenance coordination and execution experience
- Extended technical knowledge in industrial systems (clean and black utilities, etc.) and pharmaceutical production equipment
- In-depth technical knowledge in pharmaceutical processes, specifically aseptic processes and equipment
- Experience with radiopharmaceutical production would be a plus
- Wide interdisciplinary knowledge and experience in international and multi-disciplinary complex environments
- Extended HSE and GxP knowledge
- Radiation and radioprotection knowledge is desirable
- Good IT knowledge: SAP, MS Office, Autocad / Solidworks or similar, coding languages
- Excellent communication skills, ability to e

📌 Senior Expert Engineering (Ivrea)
🏢 IT58 (FCRS = IT058) Advanced Accelerator Applications Italy
📍 Ivrea