Job Description 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.
Job Description
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 training of 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
Novartis purpose is to reimagine medicine to improve and extend peoples 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: You can find everything you need to know about our benefits and rewards in the Novartis Life.
Key Skills
* Lean Manufacturing
* Hand Tools
* Basic Math
* Math
* Mechanical Knowledge
* Assembly Experience
* Computer Literacy
* Schematics
* cGMP
* Clamp Truck
* Programmable Logic Controllers
* Manufacturing
Employment Type: Full-Time
Vacancy: 1
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