COMMISSIONING & QUALIFICATION SPECIALIST

About the Role The Commissioning & Qualification Specialist 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 Specialist coordinate and executes commissioning and qualification activities to maintain and improve existing manufacturing technologies and to aid in the implementation of innovative improvements.
Maollaborates 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.
• Collaborating with the C&Q Engineers for the generation and maintenance of the Commissioning and Qualification relevant procedures and documents (Risk Assessment/Periodic Requalification Planning/System Impact Assessment).
• Writing, reviewing or approving C&Q protocols and reports under its area of responsibility (HVAC, Utilities, Production Equipment, Lab Equipment).
• Executing the C&Q activities assigned internally on Plants and Equipment and collaborating with the C&Q Engineers for the planning/coordination of the C&Q activities assigned to external technicians.
• Working 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.
• Collaborating with the C&Q Engineers for the management of Change Controls and Deviations related to Plants and Equipment.
• Supporting Maintenance and Calibration Functions to improve compliance and quality.
• Supporting 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.
• Collaborating with technical development, other sites, and the global engineering network to facilitate the transfer of technical knowledge Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams 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 2 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.
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