Crespellano, Italy


Life Sciences



Job ID


Be a part of a revolutionary change. At PMI, we’ve chosen to do something incredible! We’re totally transforming our business and building our future on smoke-free products with the power to improve the lives of a billion smokers worldwide. We’re also exploring new categories, looking beyond nicotine to develop a new portfolio of innovative products. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products. Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free and beyond nicotine future, your work could change the lives of millions. Your ‘day to day’ As Validation Lead you will define, document, and maintain the risk assessments (Project and Change) of new and existing system to support risk-based validation approach. It includes to establish validation plan & validation report of project for which you are accountable for. More specifically, you will: • Perform assessment of computerized systems to determine need of validation • Establish and lead validation strategy for computerized systems related to manufacturing • Perform QA review of SME documentation produced to support the system validation. • Manage deviation during validation and ensure proper system compliance • Ensure compliance of systems during their entire lifecycle from commission to decommissioning including data retention need • QA review Data governance documentation which are produced prior to project to document data flow and conceptual data model supporting risk analysis of the envisaged system. • Participate to data maturity assessment in collaboration with data integrity teams to establish systems and process flow. • Participate in the development and improvement of QMS procedures and practices for data integrity and CSV as it relates to the area of responsibility. • Advice project manager and service manager for validation activities and workload to ensure proper planning and workforce mobilization to perform the activities. • Train and coach on the validation and DI strategy and practices as well as practices related to CSV and DI. • Advice the business system owner on the fit for purpose of the system and provide input to release the system for use by the business. Who we're looking for: • University degree in science, engineering or equivalent. • Seasoned experience in computerized system activities and validation (CSV/GAMP). • Demonstrated experience in Manufacturing automation and manufacturing 4.0 • Proven experience in cloud systems validation • Substantial experience working in regulated environment such as GxP and ISO 17025 for CSV. • Proven experience in dealing with external suppliers and third parties. • Effective communicator with the ability to negotiate and influence. • Managerial courage coupled with project management skills. • IS and business experience would be an asset. • Fluent in English both oral and written. What we offer Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: • Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore. • Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong. • Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress. • Take pride in delivering our promise to society: to improve the lives of a billion smokers.