Pilot Plant Manufacturing Technician

Healthcare Businesswomen’s Association; Ivrea; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading healthcare organization in Piemonte, Ivrea, is seeking a Pilot Plant Manufacturing Technician to manage the production of radiopharmaceuticals. The ideal candidate should have a technical or scientific education, a minimum of 2 years in GMP roles, and be proficient in manufacturing IT systems. The role involves compliance with strict regulations and documentation standards, ensuring quality and sterility in production processes. Join us to make a difference in healthcare!

Competenze

• Minimum 2 years in GMP manufacturing support or technical roles, preferably in sterile injectables.
• Strong scientific/technical understanding and quick grasp of production processes.
• Quality and compliance mindset with knowledge of regulatory requirements.

Mansioni

• Shift work for preparation, production, and packaging/shipping of sterile radioactive drugs.
• Prepare raw materials and batch kits; manage stock and waste per Production Supervisor instructions.
• Complete GMP documentation per ALCOA+ and promptly report deviations/OOS.

Conoscenze

Environment

Health And Safety (EHS)

Laboratory Equipment

Manufacturing Process

Materials Science

Process Simulation

SOP (Standard Operating Procedure)

Formazione

Technical high school education

University degree in Science (Pharmacy, Chemical Engineering, Pharmaceutical Technology)

Strumenti

Manufacturing IT systems (e.g., SCADA, HMI)

Office software

Descrizione del 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)