Subject Matter Expert Process Validation & Life Cycle Management - Respiratory Orals & Small Mol.

Date: 19 May 2026 Department: Corporate Products Industrialisation Business Area: Industrial Operations & HSE Job Type: Direct Employee Contract Type: Permanent Location: About us Chiesi 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. At 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 Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity 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. Global Technical Operations & Supply Global Technical Operations & Supply (Global TechOp&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global TechOp&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners. Who we are looking for This is what you will do You will act as Subject Matter Expert for Process Validation and technical maintenance activities, supporting industrialization, product technology transfer and life cycle management for Respiratory, Orals & Small Molecules products. You will provide specialist technical support to R&D, Operations, Quality and external stakeholders, including contract manufacturers and subcontractors, ensuring robust and compliant manufacturing processes throughout the product lifecycle. As part of R&D Product Teams and the Extended Technical Team, you will support industrial process validation activities and coordinate technical maintenance on in‑market products, contributing to solutions aligned with Quality requirements and business needs. You will be responsible for Participating to Technology transfer process between different Chiesi group sites (R&D included) and/or subcontractors operated by Global TechOP&S with a focus on Process validation and all the propaedeutic activities Collaborating in designing TT documents and matrix, supporting the identification of scientific rationales to be reported in quality and regulatory documentation Finalizing the industrialization of new products within the R&D Product Teams (as a member of the Extended technical team) and to structure the industrial Process validation Executive responsibility for Technology transfer activities between different Chiesi group sites (R&D included) and/or subcontractors operated by Global TechOP&S, both for primary and secondary technology transfer activities, with a focus on Process validation and all the propaedeutic activities Scouting for new equipment/technologies and tools to improve manufacturing execution and process robustness Being the key reference person for Global TechOP&S functions (incl. plant Site Process SME - Parma, Blois, Santana, Nerviano Virtual plant) supporting with technical expertise for maintenance activities for in-market products, regarding maintenance needs collection, planning and execution, challenges identification, supporting geo-expansion and module X maintenance Being the key reference person in Global TechOP&S functions for product lifecycle, reporting to dedicated governance bodies. Supporting Chiesi functions (Global and Local) in preparation to audits (inspection readiness streams) Partecipating constructively or coordinate Extended Teams and work packages development meetings (e.g., ETTs, Technical Maintenance, Operative Teams…) Supporting the development and evolution of Chiesi products toward sustainability-driven initiatives, through the Ecofriendly challenge and perform product Sustainability Assessment and define improvement plans Providing scientific evaluation and effective methodological support in problem solving, contributing in a significative way to identify root causes. Participating constructively to the Extended Teams for Task forces You will need to have Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field. 5+ pharmaceutical/biotech industry years in drug product manufacturing, with at least 3 years of experience in a similar role or in Manufacturing/Technology and Analytical Quality/QC area. Fluency in written and verbal communication in English. Willingness to travel up to 30%. Business trips may not be required at all times, travel frequency can vary depending on project/business needs. We would prefer for you to have Direct experience on respiratory products (DPI and/or pMDI) and/or oral solid and small molecules. Direct and solid experience in Process Validation and Lifecycle Management activities. Experience working in multicultural and multinational environments. Experience working within a CRO or CMO environment. Technical Skills Demonstrated strength in problem‑solving, and interpersonal communication, with a proven ability to work effectively across diverse technical, business, and operational functions. Solid understanding of the pharmaceutical industry and end‑to‑end drug products manufacturing. Experience in pharmaceutical or biotech MSAT process development and/or GMP manufacturing. Strong working knowledge of current regulations, quality expectations, and industry trends related to manufacturing and testing. Soft Skills Ability to lead cross-functional project teams in an international environment, including internal and external manufacturing (CMOs/CDMOs). Work and think in a proactive way to support business continuity. Strong interpersonal skills and ability to interact with different stakeholders. Location The primary work location is Parma (Italy). The role offers flexibility, combining on‑site presence with remote work. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. DISCOVER ALL OUR JOB OPPORTUNITIES Please enable JavaScript Screen readers cannot read the following searchable map. 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