COMMISSIONING & QUALIFICATION ENGINEER

About the Role The Commissioning & Qualification Engineer provides the Site with Subject Matter Expert (SME) knowledge and skills related to commissioning and qualification activities and requirements of Plants and Equipment as well as management of related Changes and Deviations.
The C&Q Engineer oversees processes and standards to maintain and improve existing manufacturing technologies and to aid in the implementation of innovative improvements.
Manages and collaborates with external consultants and internal resources to achieve timely document generation and execution according to regulatory and project requirements.
Your key responsibilities.
Your responsibilities include, but are not limited to.
• Being responsible for the generation and maintenance of the Commissioning and Qualification relevant procedures and documents (Risk Assessment/Periodic Requalification Planning/System Impact Assessment).
• Write, review or approve C&Q protocols and reports under its area of responsibility (HVAC, Utilities, Production Equipment, Lab Equipment).
• Manage and support external/internal validation technicians during planning and execution of C&Q activities.
• Work with the local Engineering team and Site Leadership Team to define priorities on the C&Q of new equipment as well as process/compliance improvements on existing processes and equipment.
• Being responsible for the management of Change Controls and Deviations related to Plants and Equipment.
• Support Maintenance and Calibration Functions to improve compliance and quality • Supports the Aseptic Expert(s) / Process Experts in troubleshooting / root cause investigation by providing a second level of specialist expertise as SME and by harmonizing and optimizing related technical processes across the units • Interfaces with local and global Engineering networks and with the technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
• Collaborate with technical development, other sites, and the global engineering network to facilitate the transfer of technical knowledge.
Diversity & Inclusion / EEO Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Role Requirements What you’ll bring to the role.
• Education.
BSc.
or MSc in Chemical Engineering, Pharmaceutical Technology, or equivalent scientific degree.
A degree in Radiochemistry is a plus • English and Italian.
proficient.
• At least 5 years of experience in GMP manufacturing relevant to the area of expertise.
Work location.
Colleretto Giacosa – Ivrea (TO) Why Advanced Accelerator Applications (AAA)? Thousands of people die of cancer around the world every day.
At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer.
How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation.
That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.
And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges.
Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Imagine what you could do at Novartis! 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.
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