PpSelect how often (in days) to receive an alert: /p h3Technical Leader Sterile Products Large Molecules (Process Validation Life Cycle Management) /h3 pDate: Feb 24, 2026 /p pJob Type: Direct Employee /p pBusiness Area: Industrial Operations HSE /p pContract Type: Permanent /p pLocation: Parma, IT /p pbAbout us /b /p pChiesi 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. /p pAt 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. /p pDiversity 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. /p pbChiesi Global Manufacturing Division /b /p pChiesi Group has three production plants: /p pbParma /b (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. /p pIn 2024, a new bBiotech Centre of Excellence /b has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins. /p pbBlois-La Chaussée Saint Victor plant /b (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. /p pbSantana de Parnaiba /b (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). /p pIn 2025, a new investment in bNerviano /b (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. /p h3This is what you will do /h3 pYou will act as the bglobal technical reference /b for sterile biotech products, ensuring technical robustness throughout the product lifecycle and delivering innovative, compliant solutions supporting the business and Quality organization. /p pYou will contribute to the definition and execution of the industrialization strategy for new products within the RD Product Teams, acting as a member of the Extended Technical Team. You will structure, plan, and coordinate industrial process validation activities to ensure robust and compliant manufacturing processes. In addition, you will provide technical leadership for lifecycle management projects concerning established products, overseeing the technical assessment and implementation of modifications to critical components, including APIs, excipients, devices, and packaging materials. /p h3You’ll be responsible for: /h3 ul liLeading and overseeing Technology Transfer activities from RD or external partners to Chiesi Group manufacturing sites or third‑party subcontractors managed by Global Tech OpS, with a strong focus on process validation. /li liCoordinating Product Technical Teams and/or contributing actively to cross‑functional workstreams and development meetings to ensure alignment and timely execution of project milestones. /li liProviding technical leadership for Industrial Management projects related to products within the established portfolio, particularly in the case of production site transfers or changes to critical components. /li liReviewing and approving technical protocols and reports, as well as bills of materials and material master data within the company information systems. /li liSupporting Program Managers, product team in the preparation of key deliverables and updates for governance bodies (e.g., TRB-PRB, Global Tech OpS, Leadership Team), including lifecycle management activities and business cases. /li liCollaborating with Virtual Plant Managers and Procurement to define the technical content of commercial agreements. /li liParticipating in due diligence activities for multidisciplinary projects, as required. /li liContributing to the global harmonization of biotech sterile manufacturing processes in collaboration with relevant stakeholders (Gloabal-Sites QA-Regulatory-Audit-Sterility assurance). /li liPerforming product Sustainability Assessments and defining improvement plans. /li /ul h3You will need to have /h3 ul liBachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field. /li li10+ pharmaceutical/biotech industry years in drug product manufacturing, with experience in aseptic processing. Manufacturing/Technology and Analytical Quality/QC /li liFluency in written and verbal communication in English. /li liWillingness to travel up to 30%. Business trips may not be required at all times, travel frequency can vary depending on project/business needs. /li /ul h3We would prefer for you to have /h3 ul liExperience working in multicultural and multinational environments. /li liExperience working within a CRO or CMO environment. /li /ul h3Technical Skills /h3 ul liDemonstrated strength in project management, problem‑solving, and interpersonal communication, with a proven ability to work effectively across diverse technical, business, and operational functions. /li liSolid understanding of the pharmaceutical industry and end‑to‑end Biotech sterile products manufacturing. /li liExperience in pharmaceutical or biotech MSAT process development and/or GMP manufacturing. /li liStrong working knowledge of current regulations, quality expectations, and industry trends related to sterile manufacturing and testing. /li /ul h3Soft Skills /h3 ul liAbility to lead bcross‑functional project teams /b in an binternational /b environment, including internal and external manufacturing (CMOs/CDMOs). /li liStrong interpersonal skills and ability to interact with different stakeholders. /li /ul h3Location /h3 pThe primary work location is Parma (Italy). The role offers flexibility, combining on‑site presence with remote work, and may allow working from other strategic European locations. /p pbWhat we offer /b /p pNo 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. /p pWe 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. /p pChiesi 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. /p pbDiscover all our opportunities /b /p /p #J-18808-Ljbffr