Business Area: Industrial Operations & HSE\nJob Type: Direct Employee\nContract Type: Permanent\nLocation: Milano, IT\nAbout us\nChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.\nAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.\nDiversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.\nChiesi Global Manufacturing Division\nChiesi Group has three production plants:\nParma (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.\nIn 2024, a new Biotech Centre of Excellence has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.\nBlois-La Chaussée Saint Victor plant (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.\nSantana de Parnaiba (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).\nIn 2025, a new investment in Nerviano (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.\nWho we are looking for\nThis is what you will do\nFor our new Site in Nerviano (Milan) we are looking for a new Validation Engineer.\nThe Validation Engineer is responsible for the execution and coordination of the Commissioning and Qualification activities relevant to Systems, Equipment, Facilities, and Utilities at the pharmaceutical manufacturing site, specialized in respiratory spray and bio-pharmaceuticals products.\nYou will be responsible for Develop Validation Master Plans (VMP) for Systems, Equipment, Facilities, and Utilities according to Chiesi standards.\nSupport the Validation Manager in the management of the Commissioning and Qualification activities (FAT, SAT, DQ, IQ, OQ, PQ).\nPrepare, or oversight external partners in the preparation, of Qualification Protocols for Systems, Equipment, Facilities, and Utilities.\nExecute, or oversight external partners in the execution, of Qualification Protocols for Systems, Equipment, Facilities, and Utilities.\nOversight Equipment Vendors and Contractors in the execution of FAT, SAT and Commissioning activities, ensuring compliance to Chiesi standards.\nReview and approve FAT, SAT, Commissioning and Technical Documentation issued by Equipment Vendors and Contractors.\nAssure Data integrity application.\nSupport the Validation Manager in the management and implementation of the Change Controls on qualified Systems and Equipment.\nCollaborate with cross-functional teams, including Engineering, Maintenance, Production, Quality Control and QA for C&Q; activities. You will need to have Degree in Engineering, Pharmacy, Chemistry, or related scientific discipline.\nMinimum 5 years of experience in pharmaceutical Commissioning and Qualification, preferably on large scale Projects.\nSolid knowledge of EU GMP, FDA CFR 21 Part 11, Annex 15, GAMP 5, and validation best practices.\nExperience with aseptic/sterile production, preferably in respiratory devices and biopharmaceuticals.\nDemonstrated experience in Systems and Equipment Commissioning and Qualification, including HVAC/Cleanrooms, Clean media and Process Equipment.\nExperience in FAT, SAT and Commissioning activities.\nStrong understanding of risk management methodologies (e.g., FMEA, QRM).\nFluent in English (written and spoken). Any other language wi