Pilot Plant Manufacturing Technician
3 giorni fa
Job Description SummaryThe 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 DescriptionKey ResponsibilitiesShift work for preparation, production, and packaging/shipping of sterile radioactive drugs in compliance with HSE, EU GMP Annex 1/3, and applicable regulationsPerform setup, cleaning, and environmental microbiological monitoring (viable and non-viable) of areas and equipment with GMP-based periodic cleaningPrepare raw materials and batch kits; manage stock and waste per Production Supervisor instructions and HSE SOPsComplete GMP documentation per ALCOA+ and promptly report deviations/OOS to Production Supervisor, Qualified Person, and HSE ManagerHandle inbound logistics, restock areas, prepare shipping packaging; check for radioactive contamination and perform decontaminationManage proper radioactive waste disposal with related records and transportSupport maintenance/qualification, train new personnel, contribute to the site quality system and continuous improvement in line with safety and GMPPerform technical tests and support process/product qualification and validation; drive feedback and improvements, tracking KPIs (successful batches, delays, OOS/deviations, audit findings, qualifications)Essential RequirementsTechnical or scientific high school education required; university degree in Science (Pharmacy, Chemical Engineering, Pharmaceutical Technology) or equivalent experience desirableMinimum 2 years in GMP manufacturing support or technical roles, preferably in sterile injectables; radiopharmaceutical experience is a plusStrong scientific/technical understanding and quick grasp of production processesQuality and compliance mindset with knowledge of regulatory requirements across multiple health authoritiesProficiency with manufacturing IT systems (e.g., SCADA, HMI) and good office software skillsTeam player with strong team spirit, adaptability, and change managementAbility to work under pressure and maintain standardsLanguage skills: Italian proficient; English desirableWhy 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 usLearn more here: You will receive:You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.Commitment to Diversity and InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Join our Novartis NetworkIf 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: Skills DesiredEnvironmentHealth And Safety (Ehs)Laboratory EquipmentManufacturing ProcessMaterials ScienceProcess SimulationSop (Standard Operating Procedure)#J-*****-Ljbffr
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