Summary
The Pilot Plant Manufacturing Technician performs end-to-end production of radiopharmaceuticals in strict adherence to current Good Manufacturing Practices and approved Standard Operating Procedures, ensuring quality, sterility, and regulatory compliance at every stage. It prepares, handles, operates, and documents materials and equipment according to validated procedures, maintaining accurate, traceable records and promptly escalating any deviations. The position follows an internal rotation plan with morning and afternoon shifts, requiring flexibility and consistent coordination to meet operational timelines and batch release objectives.
About the Role
Key responsibilities:
- Shift work for preparation, production, and packaging/shipping of sterile radioactive drugs in compliance with HSE, EU GMP Annex 1/3, and applicable regulations
- Perform setup, cleaning, and environmental microbiological monitoring (viable and non-viable) of areas and equipment with GMP-based periodic cleaning
- Prepare raw materials and batch kits; manage stock and waste per Production Supervisor instructions and HSE SOPs
- Complete GMP documentation per ALCOA+ and promptly report deviations/OOS to Production Supervisor, Qualified Person, and HSE Manager
- Handle inbound logistics, restock areas, prepare shipping packaging; check for radioactive contamination and perform decontamination
- Manage proper radioactive waste disposal with related records and transport
- Support maintenance/qualification, train new personnel, contribute to the site quality system and continuous improvement in line with safety and GMP
- Perform technical tests and support process/product qualification and validation; drive feedback and improvements, tracking KPIs (successful batches, delays, OOS/deviations, audit findings, qualifications)
Essential requirements:
- Technical or scientific high school education required; university degree in Science (Pharmacy, Chemical Engineering, Pharmaceutical Technology) or equivalent experience desirable
- Minimum 2 years in GMP manufacturing support or technical roles, preferably in sterile injectables; radiopharmaceutical experience is a plus
- Strong scientific/technical understanding and quick grasp of production processes
- Quality and compliance mindset with knowledge of regulatory requirements across multiple health authorities
- Proficiency with manufacturing IT systems (e.g., SCADA, HMI) and good office software skills
- Team player with strong team spirit, adaptability, and change management
- Ability to work under pressure and maintain standards
- Language skills: Italian proficient; English desirable
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life
Handbook.https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines
Location
Italy
Site
Ivrea
Company / Legal Entity
IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl
Functional Area
Research & Development
Job Type
Tempo pieno
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.