Parttime Engineer

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Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. We believe our differences make us stronger. Chiesi Global Manufacturing Division Chiesi Group has three production plants: Parma (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. In 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. Blois-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. Santana 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). In 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. For our new Site in Nerviano (Milan) we are looking for a new Validation Engineer. The 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. Develop Validation Master Plans (VMP) for Systems, Equipment, Facilities, and Utilities according to Chiesi standards. Support the Validation Manager in the management of the Commissioning and Qualification activities (FAT, SAT, DQ, IQ, OQ, PQ) . Prepare, or oversight external partners in the preparation, of Qualification Protocols for Systems, Equipment, Facilities, and Utilities. Execute, or oversight external partners in the execution, of Qualification Protocols for Systems, Equipment, Facilities, and Utilities. Oversight Equipment Vendors and Contractors in the execution of FAT, SAT and Commissioning activities, ensuring compliance to Chiesi standards. Review and approve FAT,



SAT, Commissioning and Technical Documentation issued by Equipment Vendors and Contractors. Assure Data integrity application. Support the Validation Manager in the management and implementation of the Change Controls on qualified Systems and Equipment. Collaborate with cross-functional teams, including Engineering, Maintenance, Production, Quality Control and QA for C&Q; activities. Degree in Engineering, Pharmacy, Chemistry, or related scientific discipline. Minimum 5 years of experience in pharmaceutical Commissioning and Qualification, preferably on large scale Projects . Solid knowledge of EU GMP, FDA CFR 21 Part 11, Annex 15, GAMP 5 , and validation best practices. Experience with aseptic/sterile production , preferably in respiratory devices and biopharmaceuticals . Demonstrated experience in Systems and Equipment Commissioning and Qualification , including HVAC/Cleanrooms, Clean media and Process Equipment. Experience in FAT, SAT and Commissioning activities. Strong understanding of risk management methodologies (e.g., FMEA, QRM). Fluent in English (written and spoken). Any other language will be considered as a plus. Commissioning (FAT, SAT, Commissioning) and Qualification (DQ, IQ, OQ, PQ) protocols and lifecycle management. Technical knowledge of Systems, Equipment, Facilities, and Utilities of a pharmaceutical manufacturing site and relevant functionalities. Compliance with global regulatory standards. Data integrity principles and Computerized System Validation (CSV). Cross-functional collaboration and stakeholder management. Willing to work in a dynamic, challenging and friendly environment No matter where your path starts at Chiesi, it leads to inspiring possi

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