摘要
About the Role
Major Accountabilities
- Guarantee the correct operation of the equipment, systems, plants present in the production site through the coordination of all the Technical activities, carried out by internal and external resources
- Coordinate the technical activities on the equipment / systems as improvement projects and upgrade projects on the same ones
- Support the production activities participating in the multi-department workshops and projects
- Guarantee the Aseptic process compliance (by equipment upgrade) and Aseptic Process improvement
- Collaborate with MS&T and Production department to understand better their needs and processes for systems compliance, efficiency, and reliability (evaluating needs for upgrade or substitution)
- Accountability and/or responsibility for the GMP documentation both external and internal
- Improvement of the qualification, validation and other GMP / technical documentation adapting it to the corporate standards
- Execute qualification (and sometimes) validation activities or coordinate external resources in the execution under own accountability
- Support the process of Continuous Improvement and Compliance for aseptic processes
- Support eCompliance improvement projects
- Guarantee the safety of internal and external resources working on the equipment, in accordance with applicable normative and corporate procedures (through the implementation of preventive measures).
- Participate in the technical investigations on the GMP deviations on the site production systems and processes
Essential requirements:
- Technical background (i.e. degree in Mechanical/Chemical/Energy Engineering or High school degree in technical field).
- Direct experience in managing pharmaceutical equipment (maintenance, calibration, requalification) with particular attention to Aseptic processes (sterilization, depyrogenation, freeze drying, aseptic filling, WFI loops, …).
- Direct experience in preparation of the GMP documentation for pharmaceutical equipment.
- Direct experience in management and coordination of external contractors and consultants.
- Fluent in Italian. Good knowledge of English.
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
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.
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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
