The Process & Validation Expert is responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.The person will be also responsible for scale-up and line transfer for hot products by developing and executing a validation strategy according to cGxP for scale-up and line transfers and alignment with all the sites.Executing and managing process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with general regulatory expectations.**Your key responsibilities**:Your responsibilities include, but are not limited to:- Support Product Steward in maintaining the process control strategy.- Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).- Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.- Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.- Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.- Contribute to registration strategy and support registration activities.- Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.- Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV).- Ensure that all manufacturing and cleaning processes are validated; overview on state of validation at site is maintained.- Support MS&T; activities in ensuring that responsible departments execute and maintain the VMP activities.- Partner with Engineering, IT, QC, AS&T; to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation.- Provide all necessary information to perform the validation documentation, align with stability experts and QC labs to organize the stability samples.**Commitment to Diversity & Inclusion**:- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._**Minimum requirements****What you’ll bring to the role**:- BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent.- 2-3 years experience in executing equipment qualifications, process validation, having led and managed validation projects, including sterile manufacturing.- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.- Ideally also 2-3 years experience in manufacturing / manufacturing science and/or technology / technical development / quality.- Thorough understanding of manufacturing processes and related process equipment.- Fluent in English and proficient in Spanish.Work location: Zaragoza.**Why Advanced Accelerator Applications?**Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, 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!****Division**Oncology**Business Unit**ADVANCED ACCELERATOR APPLICATIONS**Country**Spain**Work Location**Zaragoza**Company/Legal Entity**AAA Ibérica S.L.U.**Functional Area**Technical Operations**Job Type**Full Time**Employment Type**Regular**Shift Work**No**Early Talent**No