Pilot Plant Manufacturing Technician

Pilot Plant Manufacturing Technician

Riassunto

Località

Ivrea

Divisione Aziendale

Tipo di contratto

Data di pubblicazione

07-11-2025

Descrizione Lavoro

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, 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
Skills Desired

Environment
Health And Safety (Ehs)
Laboratory Equipment
Manufacturing Process
Materials Science
Process Simulation
Sop (Standard Operating Procedure)

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