الملخص
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, Autocad / Solidworks or similar, coding languages
- Excellent communication skills, ability to effectively present complex ideas and solutions to executive management, technical experts, and regional/local teams
- Excellent organizational skills as well as capability to effectively work in a team with multiple different backgrounds
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: € 45,300 to €84,100
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
