SME - PROCESS VALIDATION

Chiesi Global Manufacturing Division Chiesi Group has four 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 , 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).
Niefern (Germany), specialized in the production of certain products for rare diseases.
The site holds a production license and a GMP certificate for secondary packaging, testing, and release of sterile semi-solid medicinal products.
In , 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.
Purpose The person will be a subject matter expert of Process Validation and technical maintenance activities within industrialization & product technology transfer and will interface with internal and external stakeholders as R&D, Operations and contract manufacturers/subcontractors.
The person will be also responsible for coordinating in-market products maintenance activities.
Main Responsibilities Act as point of contact for GMD functions (incl.
plant Site Process SME) on technical expertise for maintenance activities for in-market products, regarding maintenance needs collection, planning and execution, challenges identification and reporting to dedicated governance bodies, including plant Site Process SME (Chiesi sites & CMO).
Act as point of contact for root cause analysis of material/product/production process deviation and OOS, where required multiple data sources and data interpretation methods.
Align and collaborate with GMD PM to define LCM activities action plan, accountabilities and ensure LCM initiatives monitoring.
Support GMD PM with the preparation of key deliverables for governing bodies (TMPT/GMD LT) updates on LCM activities (e.
., business case).
Participate constructively or Coordinate Extended Teams and work packages development meetings when required (e.
., ETTs, Technical Maintenance, Operative Teams…).
Collaborate with Virtual Plant Managers and Procurement in defining commercial agreements technical contents Participate to diligence activities in projects involving more disciplines, as needed.
Experience Required At least 5 years’ experience in the Chemical – Pharmaceutical industry At least 3 years’ experience in development / scale-up or technology transfer products in international pharmaceutical environment Preferred professional experiences.
Process Validation, Production, Quality Control or Quality Assurance, Process Development in Pharma environment   Education Bachelor or Master's Degree in scientific disciplines Languages Fluent English Technical Skills Sound competences in pharmaceutical technologies.
Sterile product/DPI/pMDI(preferred) Good Knowledge on Lean Six Sigma and Six Sigma methods.
Good knowledge of pharmaceutical legislation and main international regulatory frameworks (cGMP, EMA guidelines, FDA and ICH) Soft Skills Communication skills Decision making Goal orientation Leadership and social influence Negotiation skills Planning and organizational skills Team working What we offer You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.
Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.
That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.