29 ott - Montà
Novartis Italia
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.
Summary
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.
About The Role
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, Autoca