Job Description Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for an experienced validation professional to help us reach our ambitious goals. As the Process & Validation Expert, you will execute and manage 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 global regulatory expectations. Key Responsibilities: Stewardship: Support Product Steward in maintaining the process control strategy. Translate applicable process parameters and the process control strategy into a focused validation plan for process validation. Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed). Validation: Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning. Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities. Author and review process, packaging or cleaning validation protocols & reports, ongoing process and cleaning verification protocols & reports. Support execution of validation activities at the shop floor. Support Product Steward for KPI reporting. Review Master Batch Records and associated change controls. Confirm revalidation need based on technical changes. Provide technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. Work collaboratively and cross-functionally to help ensure that process risks are analyzed, appropriately controlled and documented. Ensure that all Site validation activities are performed in line with current Novartis requirements and cGMP, manage deviations associated with process validation and make recommendations for deviation resolution as well as prevention of reoccurrence. Launch & Transfer: Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled, and to ensure that commercial processes are validation ready. Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation. Essential Requirements: BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology and 2 years of experience in manufacturing, manufacturing science and technology, technical development or quality; including prior experience in executing process validation. Thorough understanding of manufacturing processes and related process equipment. Fundamental understanding of standard pharmaceutical analytical testing. Strong working knowledge of quality systems and regulatory requirements across multiple health authorities. Expert in reviewing and writing technical reports. Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: novartis-life-handbook.pdf. 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. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodationsnovartis.com or call 1(877)395-2339 and let us know the nature of your request and your contact information. Salary Range: $97,600.00 - $146,400.00 Skills Desired: Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General HSE Knowledge, Including GDP, Knowledge Of CAPA, Knowledge Of GMP, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, SOP (Standard Operating Procedure) J-18808-Ljbffr