Summary
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 external resources
· Coordinate the technical activities on the equipment 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 equipment 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 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).
Key Performance Indicators
Active collaboration in multi-department teams to guarantee:
· Compliance of the production processes (by equipment and systems compliance)
· Execution of the Production planning (by efficiency and reliability of the equipment)
· GMP compliance and eCompliance of the equipment and systems (by respecting maintenance, calibration, and requalification plans)
· Qualification and Validation of the new equipment or systems respecting scheduling and budget of the Investment projects
· Execution of the Site Quality Plan
Job Dimensions
Subordinate Functions: None
Number of Associates: Direct: 0; Indirect: 2-3
Financial responsibility (where appropriate): N/A
Impact on the organisation (where appropriate): High.
Efficiency and Reliability of the equipment as well
as GMP Compliance and eCompliance is
necessary pre-requirement to guarantee:
- Product quality
- Production planning
- Quality Plan respect
Ideal Background (State the minimum and desirable education and experience level)
Education: Batchelor Degree In Engineering (5 years) – preferably electrical or mechanical
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.
