Validation Lead – Neuchatel, Switzerland 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 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 ‘day to day’ • Define, document and maintain the risk assessments (Project and Change) of new and existing system to support risk-based validation approach. • Establish validation plan (Strategy) & validation report (Control) of the project. • Perform QA review of SME documentation produced to support the system validation. • Perform 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 in the development / improvement of QMS procedures and practices for data integrity / 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 carry out the activities. • Train and coach on CSV validation and DI strategy / practices. • 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 technology, science, engineering or equivalent. • Substantial experience in computerized system validation area or validation activities (CSV/GAMP). • IS business experience in SAP, MES, PLM, Veeva is an advantage • Sound expertise interacting with external suppliers and third party. • Good knowledge of GxP/ISO17025/TPMP for CSV. • Good communication, coaching, negotiation project management skills • Fluent in written and spoken English; French is an asset. What we offer Our success depends on the people 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: a smoke-free future. #LI-Hybrid
